DDrare: Database of Drug Development for Rare Diseases

46. 悪性関節リウマチ
［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (+) erythromefloquine; (+) isomer of racemic mefloquine; (+) isomer or racemic mefloquine; (+)erythromefloquine; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepropanenitrile,; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,; (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-beta-oxo-1-; (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-; (CDP6038; 0109-0012A 100 mg/ml; 0109-0012A 25 mg/ml; 0109-0012A 50 mg/ml; 0114-0006B; 0881; 1 ml 0.9 % NaCl; 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c; 100 mg LX3305 QD; 118-42-3; 13-valent pneumococcal conjugate vaccine; 15-O labeled water; 150 mg LX3305 QD; 18F-FDG; 18F-GE-180; 1H-Pyrazol; 2 million hMSC/kg; 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt; 200 mg LX3305 QD; 23-Valent Pneumococcal Polysaccharide Vaccine; 23-valent pneumococcal polysaccharide vaccine; 250 mg LX3305 BID; 250 mg LX3305 QD; 2593; 300 mg LX3305 QD; 331731-18-1; 4 million hMSC/kg; 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide; 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide; 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide; 40 mg MSB11022; 400 mg LX3305 QD; 42942019; 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin; 50 mg AP1189; 50 mg Etanercept; 50 mg LX3305 QD; 500 mg LX3305 QD; 6 million hMSC/kg; 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate; 68Ga-BNOTA-PRGD2; 68Ga-FAPI; 68Ga-NEB; 7-valent Pneumococcal Conjugate vaccine; 70930.00.00; 8594739041288; 89Zr-DFO-CZP; 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline; 9512; 99mTc-3PRGD2; 99mTc-S-HYNIC Certolizumab pegol; 99mTc-rhAnnexin V-128; A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs; AB1010; ABA, open-label (OL); ABATACEPT; ABBV-105; ABBV-105, A-1519938.0; ABBV-257; ABBV-3373; ABP 501; ABP 710; ABP 710 - Biosimilar to infliximab; ABP 798; ABP 798 - Biosimilar to rituximab; ABP 798 Biosimilar to Rituximab; ABT 494; ABT 494 12mg; ABT 494 3mg; ABT-122; ABT-494; ABT-494 15mg; ABT-494 30mg; ABT-Humira; ABX464; ABX464 100mg; ABX464 50mg; AC430; ACTHAR; ACTHAR gel; ACZ885; ACZ885 (investigational); ACZ885 Drug Substance; AD 452; AD 452 18 mg tablet; AD 452 4.5 mg Tablet; AD 452 9 mg tablet; ADALIMUMAB; ADALIMUMAB HUMIRA; ADALIMUMAB-EU; ADL5859; AGM 719; AIN457; AIN457F; AK106-001616; ALD518; ALD518 monoclonal antibody (anti IL-6 mAb); ALENDRONIC ACID; ALLOGENEIC MESENCHYMAL PRECURSOR CELLS; ALX-0061; ALX-0061 Nanobody; AMG 108; AMG 162; AMG 357; AMG 570; AMG 592; AMG 714; AMG 719; AMG 827; AMG 827 140 mg; AMG 827 210 mg; AMG 827 70 mg; AMG592; AMOXICILLIN; AMP; AMP-110; AMT; AMT-101; ANAKINRA; ANIFROLUMAB; AP1189; APLA12; ARA290; ARAVA; ARAVA®; ARCOXIA; ARRY-371797, p38 inhibitor; ARRY-438162; ARRY-438162, MEK inhibitor; ART621; AS; ASK8007; ASP015K; ASP015K hydrobromide; ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide; ASP1707; ASP2408; ASP2409; ASP5094; ATACICEPT; ATI-450; ATN-103; ATN-103 10 mg q4wks; ATN-103 10 mg q8wks; ATN-103 30 mg q4wks; ATN-103 80 mg q4wks; ATN-103 80 mg q8wks; ATORVASTATIN; AVE9897; AZATHIOPRINE; AZD5672; AZD9056; AZD9056 hydrochloride; AZD9567; AZD9567 10 mg; AZD9567 125 mg; AZD9567 155 mg; AZD9567 20 mg; AZD9567 40 mg; AZD9567 80 mg; AZD9567 Monohydrat; AZD9567 monohydrate; Abatacept; Abatacept (ABA) + Methotrexate (MTX), double-blind (DB); Abatacept (BMS-188667); Abatacept (IV); Abatacept (SC); Abatacept + Methotrexate; Abatacept + Vaccines; Abatacept + csDMARD; Abatacept + vaccines; Abatacept Injection; Abatacept Placebo; Abatacept Prefilled Syringe; Abatacept, rituximab or tocilizumab; Acalabrutinib; Aceclofenac; Acellbia; Acetaminophen; Acetaminophen tablets; Acetate; Acetylsalicylic Acid; Acetylsalicylic acid; Acide folique; Actemra; Actemra(EU-licensed); Acthar; Acthar Gel; Acthar Injectable Product; Active comparator; Acycloguanosine; Adalimuab, Etanercept, Tocilizumab, or Abatacept; Adalimumab; Adalimumab (ADA); Adalimumab (HUMIRA®); Adalimumab (Humira); Adalimumab (Humira®); Adalimumab (up to 9 months exposure); Adalimumab - GP2017; Adalimumab - US licensed Humira; Adalimumab 40 mg; Adalimumab 40 mg subcutaneous (SC) every other week (EOW); Adalimumab 40mg q2w; Adalimumab 80 mg; Adalimumab Injection; Adalimumab PFS and Pen; Adalimumab with methotrexate; Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe; Adalimumab, current formulation; Adalimumab, new formulation; Adalimumab, plus prednisone; Adalimumab-Pfizer; Adalimummab; Adefovir; Adenin; Administration of Cimzia®; Agrippal S1 (Influenza vaccination); Alemtuzumab; Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994); Alendronat Teva; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alendronic Acid; Alendronic acid; Alfacalcidol; Alkaline Phosphatase; Allogeneic Mesenchymal Precursor Cells; Allopurinol; Aluminium; Aluminium hydroxide; Aluminium phosphate; Amgevita; Aminopterin; Amoxapine; Amoxapine & dipyridamole; Amoxicilina; Amoxicillin; Anakinra; Anakinra (Kineret®); Anakinra (r-metHuIL-1ra); Anakinra and PEG sTNF-R1; Andecaliximab; Angiotensin; Angiotensin receptor blockers; Anifrolumab; Anifrolumab (MEDI-546); Anti IL 6 mAb; Anti IL-1beta antibody; Anti IL-1beta antibody, subclass IgG4; Anti IL-1ß antibody; Anti IL-1ß antibody, subclass IgG4; Anti LP40 antibody, subclass IgG4 LA294; Anti Lymphotoxin Alpha; Anti TNF + Meth; Anti human granulocyte-macrophage colo; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody; Anti lymphotoxin alpha; Anti-C5aR; Anti-CD20 small modular immunopharmaceutical, WYE-400087; Anti-GM-CSF receptor alpha; Anti-IL-20; Anti-IL-20 (109-0012); Anti-IL-6 mAb; Anti-Interleukin-6 Monoclonal; Anti-Interleukin-6 Monoclonal Antibody; Anti-TNF; Anti-TNF Biologics Therapy; Anti-TNF biologics; Anti-TNF humanized antibody Fab fragment - PEG conjugate; Anti-TNF humanized antibody Fab' fragment - PEG conjugate; Anti-TNF suspended perioperatively; Anti-TNF therapy; Anti-TNF therapy (etanercept or adalimumab); Anti-TNF-alpha; Anti-TNFa continued perioperatively; Anti-Tumor Necrosing Factor (TNF) Therapy; Anti-inflammatory drugs; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R.; Antihistamine; Apratastat; Apremilast; Apremilast 20 mg; Apremilast 30 mg; Arava; Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.); Arava 20 mg filmdrasjerte tabletter; Arcoxia; Arginine; Arm B: Rituxan®/Mabthera®; Arthroscopy & saline irrigation alone; Artilog; Ascal(r) / carbasalate calcium; Asendis; Asendis 50 mg; Aspirin; Aspirin 81mg tablet; Aspirin Tablets; Atacicept; Atacicept: with loading dose; Atorvastatin; Atorvastatin tablet 20 mg; Auto Injector; Autologous adipose derived stem cells; Autologous apoptotic cells injection; Autologous mesenchymal stem cells; Autologous stromal vascular fraction cells; Avelox- Moxifloxacin; Avelox®; Azathioprin; Azathioprine; B03BB01; BARICITINIB; BAT1806; BAT1806 injection; BCD-055; BCD-089; BCD-089, 162 mg, s/c, q2w; BCD-089, 162 mg, s/c, qw; BD; BDMARD; BDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept); BETAMETHASONE ACIBUTATE; BG00012; BG9924; BGX-0214; BI 655064; BI 655064 high dose; BI 655064 low dose; BI 655064 medium dose; BI 695500; BI 695501; BI 695501 Autoinjector; BI 695501 Prefilled syringe; BIAP; BIBR 796 BS; BIIB023; BIIB057; BIIL 284 BS high dose; BIIL 284 BS low dose; BIIL 284 BS medium dose; BIMEKIZUMAB; BIRB 796 BS, high dose; BIRB 796 BS, low dose; BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin); BMS-188667; BMS-582949; BMS-582949 and Methotrexate; BMS-817399; BMS-945429; BMS-986104; BMS-986142; BMS-986142 200mg; BMS-986142 350mg; BMS-986195; BMS-986251; BMS188667; BMS986142; BMS986195; BNP; BORTEZOMIB; BOW015; BR9001; BR900A; BREDININ; BRL-049653; BT061; BT061 (CD4 monoclonal antibody); BT971; BTK Inhibitor; BTT-1023; BUMEKIZUMAB; BUPIVACAINE HYDROCHLORIDE; Balance; Baminercept; Baminercept alfa; Baminercept alfa (BG9924); Baricitinib; Baricitinib, olumiant®; Behavioral: AbbVie Care 2.0; Behavioral: Balance exercise; Behavioral: Cannabis questionnaire; Behavioral: Dietary Counseling; Behavioral: Dietary guidance; Behavioral: Dietary recommendations; Behavioral: Instructional handouts; Behavioral: Marching in place; Behavioral: Physical therapist instruction and monitoring via teleconferencing; Behavioral: Posture training; Behavioral: Questionnaire; Behavioral: Resistance exercise; Behavioral: TIP / IMPACT Plus Care Coordination; Behavioral: Web-based instructional videos; Belatacept; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 4 mg/kg; Benepali; Benzimidazole; Benzimidazole,5-methoxy-2-[[(4-methoxy- 3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole; Benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole; Betamethasone; Bi 695500; Bicain spinal; Bimekizumab; Binyrebarkhormon; Binyrebsrkhormon; Biodmards; Biologic Agents; Biologic DMARD; Biologic TNFi; Biological agents; Biologics; Biosimilar; Biosimilar Infliximab; Biosimilar infliximab; Biosimilar product to adalimumab; Blood; Blood sample; Blood samples; Blood tests; Boostrix; Boostrix®; Borage seed oil; Bortezomib; Bovine intesastinal alkaline phosphatase (bIAP); Branebrutinib; Bredinin tablet 150mg; Bredinin tablet 50mg; Bucillamine; Bupivacaine; Bupivacaine hydrochloride; Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Buprenorphine; Buprenorphine Transdermal Patch; Buprenorphine transdermal patch; C. albicans; C10AA05; CAM-3001; CANNABIDIOL; CAPTURE; CBD; CC; CC-10004; CC-292; CCI-779; CCR1 Antagonist; CCX 354; CCX 354-C; CCX-354; CCX-354-C; CCX354; CCX354-C; CD; CDMARD; CDP; CDP 6038 SC; CDP6038; CDP870; CDP870 100mg; CDP870 200mg; CDP870 400mg; CDP870 Fab'-PEG; CE 224,535; CE-224,535; CELBESTA®; CELEBREX; CELEBREX 200MG 20CPS; CELEBREX®; CELECOXIB; CERTOLIZUMAB PEGOL; CERTOLUZIMAB PEGOL; CF101; CF101 1 mg; CF101 2 mg; CFZ533; CH-1504; CH-4051; CHS-0214; CICLOSPORIN; CIMZIA; CKD-374 5mg Tab.; CKD-506; CLAZAKIZUMAB; CLS; CMAB008; CNTO 136; CNTO 136 100 mg; CNTO 136 25 mg; CNTO 136 50 mg; CNTO 136 IgG; CNTO 148; CNTO 1959; CNTO 1959 + MTX (Group 4); CNTO 1959 + MTX (Group 5); CNTO 1959 IgG; CNTO 6785 100 mg; CNTO 6785 15 mg; CNTO 6785 200 mg; CNTO 6785 50 mg; CNTO1275; CNTO136; CNTO148; CNTO6785; COLECALCIFEROL; CP; CP 690,550; CP 690550 MR; CP-195,543; CP-690, 550 - 10; CP-690,55-10; CP-690,550; CP-690,550 (tasocitinib); CP-690,550 (tofacitinib); CP-690,550 + methotrexate; CP-690,550 – 10; CP-690,550-10; CP-690-550; CP690,550; CR 1; CR 2; CR 3; CR0686; CR6086; CR6086Z; CRX-139; CRx-102; CRx-102 (2.7/180); CRx-102 (2.7/360); CRx-139; CRx-150; CT- P10; CT-P10; CT-P13; CT-P17; CT-P17 SC; CT-P17 SC AI (adalimumab); CTLA4Ig; CZP; Caffeine; Calcitriol; Calcium; Calcium and cholecalciferol; Calcium carbonate; Calcium citrate; Canakinumab; Canakinumab (investigational); Canakinumab (proposed); Cannabidiol; Cannabidiol tablet 10 mg; Cannabis; Carbasalate calcium; Carbon; Carbonate; Celebra; Celebra (celecoxib); Celebrex; Celebrex 200 mg; Celebrex 200 mg Hartkapseln; Celebrex 200 mg capsule, hard; Celecoxib; Celecoxib 200mg capsule; Ceramic on Polyethylene articulation; Certolizumab; Certolizumab Pegol; Certolizumab Pegol (CZP); Certolizumab Pegol (CZP) 200 mg; Certolizumab Pegol (CZP) 400 mg; Certolizumab Pegol + Methotrexate (MTX); Certolizumab Pegol 200 MG/ML [Cimzia]; Certolizumab pegol; Certolizumab pegol (CDP870); Certolizumab pegol (CDP870, tradename Cimzia); Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg); Certolizumab pegol (CZP); Cetrorelix; Cevidoplenib; Chicken; Chicken type II collagen; Chimeric Human-Murine IgG1 <Monocolonal Antibody; Chimeric human/mouse anti-CD-20 monoclonal antibody; Chlor; Chloride; Chloroquine; Cholecalciferol; Chong Kun Dang Tofacitinib Tablet; Chromium; Ciclosporin; Cimzia; Cimzia 200 mg injeksjonsvæske, oppløsning; Cimzia 200 mg solution for injection; Cimzia®; Citalopram; Classic DMARDs treatment group; Clazakizumab; Clindamycin; Clobetasol; Clobetasol Propionate; Clobetasol propionate; Clofarabine; Co-medication: Synthetic DMARDs; Cobalt; Cobiprostone; Cod; Cod liver oil; Coenzyme Q10; Colchicine; Colecalciferol; Collect of 10 ml of peripheric blood for DNA extraction; Combination; Combination Product: Methotrexate; Combination Steroid; Combination fish oil and borage seed oil; Combination of Minocycline and MTX or MTX alone; Commercial Formulation Etanercept; Comparator: Diclofenac sodium; Comparator: diclofenac; Comparator: naproxen tablet 500 mg; Control; Control group; Control intervention (no dexamethasone); Conventional DMARD combination; Conventional DMARDs; Conventional Synthetic DMARD; Corn; Corn oil capsules; Corticosteroid and non-biological agents.; Corticosteroid or NSAID; Corticosteroids; Corticotrophin; Corticotrophin 80 units; Corticotropin; Creatine; Creatinine; CsDMARD(s); CsDMARDs; Cura-100; Curcumin; Curcumin (Longvida™); Cyclophosphamide; Cyclosporin; Cyclosporin A; Cyclosporine; Cyklokapron®; D2E7; D569 Tab.; DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS; DELTACORTENE FORTE*10CPR 25MG; DEPALGOS*20+325MG 28CPR RP; DFO; DHA; DIBASE*IM OS 2F 1ML 300000UI/M; DIPHTHERIA TOXOID; DMARD; DMARD Therapy; DMARD cessation; DMARD maintenance; DMARDS; DMARDs; DMARDs (disease-modifying antirheumatic drugs); DMARDs (methotrexate; DMARDs or Biologics; DRL_RI; DRONABINOL; DWP422 25mg; Dacortin ®; Dalacin C; Dalacin C phosphate; Decortin; Decortin 5mg tablets; Decortin®; Decrease Tocilizumab, Abatacept; Defanyl 50 and 100 mg; Dekavil; Deltacortril; Deltacortril Enteric; Denosumab; Depemedrone; Depo Medrol; Depo medrol; Depo-Medrone; Device: AI-1000 G2; Device: AS Domelock System; Device: Abatacept combination product (ACP); Device: Active stimulation; Device: Adalimumab delivered in Physiolis autoinjector; Device: Adalimumab delivered in Physiolis syringe; Device: Adalimumab delivered in current autoinjector; Device: Adalimumab delivered in current syringe; Device: Auto-Injector Device (AID); Device: Autoinjector; Device: C-Stem™ AMT Femoral Component (standard and high off-set variants); Device: CLS Brevius stem with Kinectiv technology; Device: Carbon Modular Radial Head; Device: Carbon Modular Radial Head replacement; Device: Ceramic on Ceramic articulation; Device: Cobalt™ Bone Cement; Device: Doppler ultrasound.; Device: E1-Hip Bearing; Device: ESAOTE MyLab60; Device: Fluorescence Imaging; Device: High-resolution peripheral quantitative computed tomography (HR-pQCT); Device: Hyperbaric Oxygen; Device: Integra TITAN™ Total Shoulder Generation 1.0; Device: Integra Titan Modular Shoulder System 2.5; Device: Magnetic Resonance Imaging (MRI); Device: Metal Radial Head; Device: Metal Radial Head replacement; Device: Metal on Polyethylene articulation; Device: MultiSpectral Imaging System; Device: Pre-filled Syringe (PFS); Device: Primus FGTI (Flexible Great toe Implant); Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001; Device: Scorpio NRG posterior stabilized (PS); Device: Sham stimulation; Device: Sham vagus nerve stimulation; Device: SimpleJectTM; Device: Simplex® Bone Cement; Device: Sofusa DoseConnect; Device: TC-A PS Total Knee Replacement System; Device: TC-PLUS Solution PS Total Knee Replacement System; Device: Technetium labelled glucosamine; Device: Total hip arthoplasty (THA); Device: Transcutaneous electrical vagus nerve stimulation; Device: VIBEX MTX; Device: Vanguard 360 TiNbN Femur with PS bearing; Device: Vanguard 360 TiNbN Femur with PSC bearing; Device: Vanguard DA 360; Device: Vanguard SSK 360 with PS Bearing; Device: Vanguard SSK 360 with PSC bearing; Device: conventional syringe - BD Ref 309604; Device: transthoracic echocardiographic; Dexamethason; Dexamethasone; Dexmedetomidine; Dextromethorphan; Dextromethorphan hydrobromide; Diacerein; Diagnostic Test: 11C-ER176; Diagnostic Test: 11C-MC1; Diagnostic Test: Adalimumab serum trough concentration; Diagnostic Test: Adalimumab trough concentration; Diagnostic Test: Biotherapy Prescription with SinnoTest® software; Diagnostic Test: CRQ; Diagnostic Test: Disease activity; Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system; Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels; Diazepam; Diazepam, melatonin; Diclofenac; Diclofenac + Omeprazole; Diclofenac sodium; Dietary Fiber Supplementation; Dietary supplement omega3 fatty acids aand vitamins; Digoxin; Dihuang; Dimeythl Fumarate; Diphtheria toxoid; Dipotassium Salt; Diprofos Depot; Dipyridamole; Dipyridamole and Amoxapine; Disease modified antirheumatic drugs or biological agents; Disease-modifying anti-rheumatic drugs; Disease-modifying antirheumatic drug; Disease-modifying antirheumatic drugs (DMARDs); DnaJ peptide; Dolquine; Donepezil; Dose level 1; Dose level 2; Dose level 3; Dose level 4; Double-blind Abatacept; Double-blind adalimumab; Doxycycline; Doxycycline Tablets; Dr. Reddy’s Rituximab (DRL_RI) 100mg; Dr. Reddy’s Rituximab (DRL_RI) 500mg; Dronabinol; Dronabinol capsule 2.5. mg; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; Drug treatment; Drug: Abatacept; Drug: Salirumab; Drug: Tocilizmab; Dummy Qing Re Huo Xue (QRHX); E-Device; E1; E6011; EC 3.1.3.1; EFALIZUMAB; EMEA/H/C000262; EN; ENBREL; ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL; ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.; ENBREL 25MG PFS INJ.; ENBREL*SC 4FL 25MG+4SIR 1ML; ENBREL*SC 4FL 50MG+4SIR+4AGHI+; ENBREL*SC 4SIR 25MG 0,5ML+8TAM; ENBREL*SC 4SIR 50MG 1ML+8TAMP; ENBREL®; ENIA11; EPA; EPAX 6000 EE 1000mg (0.6 gr DHA+EPA); ERB-041; ERMM-1; ETANERCEPT; ETN; ETN Alone; ETN+MTX; ETORICOXIB; EU-Humira; EU-approved RoActemra; EU/1/99/126/017; EU/1/99/126/020; Ebetrexat; Edoxaban; Efalizumab; Efexor XL 75 mg; Efexor XL 75 mg (venlafaxine); Eldecalcitol; Enalapril; Enalapril Maleate; Enbrel; Enbrel (Etanercept); Enbrel (etanercept); Enbrel 25 mg; Enbrel 25 mg powder and solvent for solution for injection; Enbrel 25mg PFS; Enbrel 50 mg; Enbrel 50 mg powder and solvent for solution for injection; Enbrel 50 mg solution for injection in pre-filled syringe; Enbrel 50mg PFS; Enbrel 50mg pre-filled pen; Enbrel 50mg pre-filled syringe; Enbrel Auto Injector; Enbrel Pre-filled syringe; Enbrel liquid; Enbrel pre-filled pen; Enbrel pre-filled syringe; Enbrel, Benepali, Erelzi; Enbrel®; Enbrel® 50 mg Solution for Injection in Pre-filled Syringe; Engineered humanized monoclonal anti-human CD19 antibody.; Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml); Enoxaparin; Entanercept; Entecavir; Epaxal; Epinephrine; Epoetin alfa; Erbium citrate; Erelzi; Ergocalciferol; Ergocalciferol 1.25 mg tablet; Esbriet; Esomeprazole; Esomeprazole 20 mg; Estradiol; Eszopiclone; Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab; Etanercept; Etanercept (ETN); Etanercept (Enbrel); Etanercept (EnbrelTM); Etanercept + Methotrexate; Etanercept , Methotrexate; Etanercept / Autoinjector A; Etanercept 50 MG/ML; Etanercept 50mg; Etanercept Auto-Injector; Etanercept Liquid; Etanercept Optimal dosing; Etanercept Pre-filled syringe; Etanercept Treatment; Etanercept biosimilar; Etanercept or adalimumab; Etanercept pre-filled syringe sq injection; Etanercept via Autoinjector A; Etanercept via Autoinjector B; Etanercept, methotrexate and depomedrone; Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc; Ethinyl estradiol; Etodolac; Etoricoxib; Etoricoxib 60 mg; Etoricoxib 90 mg; Evobrutinib; Experimental: Arm A: DRL_RI; F8IL10; FANG(30); FB704A; FILGOTINIB; FKB327; FKB327 AI; FKB327 PFS; FPA008; FR104; FSME-IMMUN; FURESTEM-RA Inj; FURESTEM-RA Inj.; FX125L; Faecal sampling; Famotidine; Fang yi qing feng shi granule; Fendrix; Fendrix suspension for injection; Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).; Fentanyl; Fentanyl transdermal patch; Ferrograd; Ferrograd Folic Tablets; Filamentous haemagglutinin; Filamentous haemagglutinin adsorbed; Filgotinib; Filgrastim; Fish Oil; Fish oil; Fish oil supplement; Fish oil, gamma-linolenic acid; Fludarabine; Flurbiprofen; Focetria; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic (or folinic) acid; Folic Acid; Folic acid; Folic acid or folate; Folic/folinic acid; Folimet; Folinic acid; Fontolizumab; FosD; Fosfamatinib Disodium; Fostamatinib; Fostamatinib 50 mg blue film-coated tablet; Fostamatinib Disodium; Fostamatinib Disodium (R935788); Fostamatinib disodium; Fostamatinib disodium (R935788); Fresenius-Kabi); G1567970; GB224 10mg; GB224 15mg; GB224 20mg; GB224 2mg; GB224 30mg; GB224 5mg; GB242; GCK 100 mg; GCK 200 mg; GCK 300 mg; GDC-0853; GDC-0853 RO7010939; GFI 38518168-AEK-B-007; GLPG0259; GLPG0259 (Part B); GLPG0259 oral capsule; GLPG0634; GLPG3970; GOL; GOLIMUMAB; GP2013; GP2013 - A Proposed biosimilar rituximab; GP2015; GP2017; GRC 4039; GS-5745; GS-6034; GS-9876; GSK 3196165; GSK1827771; GSK1841157; GSK2982772; GSK2982772 60 mg; GSK2982772A, where A denotes the free base; GSK3117391; GSK3152314A; GSK315234; GSK315234 Injection 100mg/mL; GSK3196165; GSK3196165 Dose 1; GSK3196165 Dose 2; GSK3196165 Dose 3; GSK706769; GW274150; GW274150 Tablets; GW406381; GW406381X; GW856553; Gadobutrol; Gadolinium; Gamma-Linolenic acid; Gerilimzumab; Ginger; Ginseng; Ginsenoside; GlucoCorticoid; Glucocorticoid Agent; Glucocorticoids (permitted,not necessary); Glucophage (metformin); Glucosamine; Gold; Golimumab; Golimumab 100 mg; Golimumab 100 mg injections; Golimumab 2 mg/kg IV; Golimumab 50 mg; Golimumab 50 mg SC; Golimumab 50 mg injections; Golimumab Final Vialed Product (FVP); Golimumab Intravenous; Golimumab Intravenous (IV); Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Pre-Filled Syringe; Golimumab liquid in prefilled pen; Golimumab liquid in prefilled pen or Prefilled Syringe; Golimumab liquid in prefilled pen or prefilled syringe; Golimumab pre-filled syringe; Golimumab prefilled pen; Golimumab prefilled pen or prefilled syringe; Grapefruit; Green Tea; Green tea group; Group 1 or Orencia treated group; Growth Hormone; Growth hormone; Gum Arabic; Gum arabic; Guna-Anti Interleukin 1; Guna-Antiinterleukin 1 alfa; Guna-Antiinterleukin 1 beta; Guna-Interleukin 10; Guna-Interleukin 4; H.P. Acthar Gel; H.P. Acthar gel; H02AB07; HA20 (IMMU-106); HA20 (Immu-106); HB-adMSCs; HBVAXPRO; HBVAXPRO 5 micrograms/0.5 ml; HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA); HBVAXPRO® 40 micrograms; HBvaxpro; HCQ; HD-TIV; HE3286; HEPATITIS B VACCINE (RDNA); HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN); HL237; HL237 tablet; HLX01; HM71224 Multiple ascending dose; HM71224 food effect; HM71224 single ascending dose; HMPL-523; HUC-MSC + DMARDs; HUC-MSC suspension; HUMIRA; HUMIRA 40 mg solución inyectable en jeringa precargada; HUMIRA*SC 2SIR+F 40MG 0,8ML+2T; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE SULFATE; HZT-501; Havrix; Hbvaxpro; Hematopoietic Stem Cell Transplantation; Hepatitis A Vaccine; Hepatitis A vaccine; Hepatitis A vaccine ( HAVRIX or EPAXAL); Hepatitis A vaccine and tetanus vaccine; Hepatitis B Vaccine; Herpes Zoster Vaccine; High dose ORTD-1; High dose of BIIL 284 BS tablets; High dose vehicle control; HrIL-2 active; HuMax-CD20; HuMax-CD4; Huang qi gui zhi wu wu granule; Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human Recombinant IgG1, lambda; Human anti TNF-alpha monoclonal; Human anti TNF-alpha monoclonal antibody; Human anti-IL6 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Human monoclonal antibody directed against CD20 on B-cells; Humanised anti-CD 20 antibody; Humanised anti-CD4 IgG1 monoclonal; Humanized TNFa monoclonal antibody; Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody; Humira; Humira (adalimumab); Humira (adalimumab) 40 mg in 0.4 ml s.c. injection; Humira (adalimumab) 40 mg s.c. injection; Humira (adalimumab) 40mg in 0.4 ml s.c. injection; Humira (adalimumab) 40mg in 0.4ml s.c.injection; Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte; Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg/0.8 ml solution for injection; Humira 40mg Injektionslösung; Humira 40mg solution for injection in pre-filled syringe; Humira 40mg solution for injection in pre-filled syringe (adalimumab); Humira 40mg/0.8 ml solution for injection for paediatric use; Humira 40mg/0.8ml solution for injection in pre-filled syringe; Humira SC; Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe; Humira, 40 mg solution for injection in pre-filled syringe; Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi; Humira®; Humira® (adalimumab); Humira® 40 mg Injektionslösung in Fertigspritze; Humira® 40 mg solution for injection in pre-filled syringe; Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe; Hyaluronic acid; Hydrocortisone; Hydrocortisone 10mg; Hydroxide; Hydroxychloroquine; Hydroxychloroquine sulfate; Hydroxycholoquine; Hydroxycloroquina; Hylase; Hyrimoz; IB-MECA; ICG-Pulsion; ICP-022; IDEC-C2B8 (rituximab); IL-2; IL-6 receptor inhibitor, humanized monoclonal antibody; IL-6 receptor inhibitor, recombinant humanized monoclonal antibody; ILV-094; IMUREL; INCB018424; INCB028050; INCB028050 phosphate; INCB028050 phosphate salt; INCB047986; INDOCYANINE GREEN; INFLIXIMAB; INN - FILGOTINIB; INN not available; INTERLEUKIN 2; IPI 145; IPI-145; IR Prednisone; IRAK 4; ISIS 104838; ISIS CRP Rx; IV Abatacept; IV golimumab; Ianalumab; Ibandronate; Ibuprofen; Idacio; Iguratimod; Iguratimod (Careram); Imatinib; Immune ablation and hematopoietic stem cell transplant; Immunoscintigraphy with radiolabeled Cimzia®.; Immunosporin; Impact; Imraldi; Imurel; Inactivated hepatitis A virus; Indocyanine Green; Indocyanine green; Indocyanine green(ICG); Infliximab; Infliximab (INF) + MTX, DB; Infliximab (Remicade); Infliximab + methotrexate (MTX); Infliximab 10 mg/kg; Infliximab 3 mg/kg; Infliximab Control; Infliximab Increased Dose; Infliximab Increased Frequency; Infliximab [infliximab biosimilar 3]; Infliximab biosimilar; Infliximab group; Infliximab, etanercept; Infliximab, etanercept, adalimumab; Infliximab, methylprednisolone, methotrexate; Infliximab-EU; Infliximab-Pfizer; Influenza vaccine; Influvac; Infusion without ALD518'; Innovator infliximab; Insulin; Integrative Medicine; Interleukin 10; Interleukin 2; Interleukin 4; Intra-articular Compound Betamethasone; Intra-articular Tocilizumab; Intraarticular betamethasone; Intraarticular dexamethasone; Intraarticular injection; Intraarticular morphine; Intravenous (IV) Abatacept; Intravenous (IV) abatacept; Intravenous Dexamethasone 1 mg; Iodine; Itacitinib; JAK 3; JAK1 / JAK2 Inhibitor; JAK1 / JAK2 Inhibtor; JHL1101; JNJ 38518168; JNJ-16240159-AAC; JNJ-38518168; JNJ-38518168 (10 mg); JNJ-38518168 (3 mg); JNJ-38518168 (30 mg); JNJ-38518168 / MTX; JNJ-38518168 50-mg Over Encapsulated Tablet; JNJ-38518168-AEK - Over Encapsulated Tablet - 50 mg; JNJ-38518168-ZBQ; JNJ-38518168-ZBQ - film-coated tablet - 10 mg; JNJ-38518168-ZBQ - film-coated tablet - 10mg; JNJ-38518168-ZBQ - film-coated tablet - 3 mg; JNJ-38518168-ZBQ - film-coated tablet - 30 mg; JNJ-38518168-ZBQ - film-coated tablet - 30mg; JNJ-38518168-ZBQ - film-coated tablet - 3mg; JNJ-39758979; JNJ-39758979 (10 mg); JNJ-39758979 (100 mg); JNJ-39758979 (30 mg); JNJ-39758979 (300 mg); JNJ-39758979 / MTX; JNJ-39758979-AAC - enteric coated tablet - 10 mg; JNJ-39758979-AAC - enteric coated tablet - 100 mg; JNJ-39758979-AAC - enteric coated tablet - 30 mg; JNJ-40346527; JNJ-40346527-AAC - capsule - 50 mg; JTE-051; Juanbi pill; K-832; KB003; KC706; KEVZARA; KINERET*SC 7SIR 100MG 0,67ML; KN019, 10 mg/kg; KN019, 5mg/kg; KR002524; Kenacort; Kenalog; Ketoprofen; Kevzara; Keyhole limpet hemocyanin; Kineret; Kineret®; Kineret® (Anakinra); Kolbet; Kunxian Capsule; L-000124467; L-000124467 (freebase); L-000124467-009J (succinat; L-000883191; L-001069957; L-883191; L-arginine; L01BA01; L01X CO2; L01XC02; L04 AB04; L04041); L04AA11; L04AA24; L04AB01; L04AB04; L04AB05; L04AC07; LBAL; LBEC0101; LD-aminopterin; LEFLUNOMIDE; LNP1955; LO4AB04; LTS 0.25mg; LTS 0.5mg; LTS 1.0mg; LX3305; LX3305 Dihydrate; LX3305 high dose; LX3305 low dose; LX3305 mid dose; LY2127399; LY2127399 (Tabalumab); LY2189102; LY2439821; LY3009104; LY3090106 - IV; LY3090106 - SQ; LY3337641; LY3337641 20 mg; LY3337641 5 mg; LY3462817; Lacosamide; Lamivudine; Lantarel; Large protein molecule; Ledertrexate; Ledertrexato; Leflunomide; Leflunomide (permitted, not necessary); Leflunomide 10 milligram (MG); Leflunomide 20 mg Tablets (Geneva Pharmaceutical); Leflunomide 20Mg Tab; Leflunomide-Sulfasalazine-Hydroxychloroquine; Leflunomidum; Leucovorin; Levobupivacaine; Levofloxacin; Lidocaine; Lingzhi and Sen Miao San; Linolenic acid; Lipitor®; Lisinopril; Lodotra®; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Long-chain n-3 PUFA; Long-circulating liposomal prednisolone; Loratadine; Losartan; Losec; Losec Capsules 20 mg; Lovastatin; Low dose ORTD-1; Low dose of BIIL 284 BS tablets; Low dose vehicle control; Loxoprofen; Lumiracoxib; Lymphoseek; M2591 25 mg QD; M2951; M2951 50 mg BID; M2951 75 mg QD; M923; MABTHERA; MABTHERA 500 mg concentrado para solución para perfusión; MABTHERA*EV 1FL 50ML 500MG; MBS2320; MC1; MDA; MDX-1100; MDX-1342; MEDI-522; MEDI5117; METFORMINE ARROW 500mg; METHOTREXAT Lederle - Tabletten; METHOTREXATE; METHOTREXATE 2.5 mg tablets; METHOTREXATE DISODIUM; METHOTREXATE HOSPIRA 2,5 mg tablety; METHOTREXATE HOSPIRA 2.5 mg tablety; METHOTREXATE SODIUM; METHOTREXATE Sodium; METHOTREXATE*100CPR 2,5MG; METHOTREXATE*10MG/1,33ML 4S; METHOTREXATE*15MG/2ML 4SIR; METHOTREXATE*2,5MG 25CPR; METHOTREXATE*20MG/2,66ML 4S; METHOTREXATE*25CPR 2,5MG; METHOTREXATE*7,5MG/ML 4SIR.; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOTREXATO; METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP; METOTREXATO SODICO; METOTREXATO SODIO; METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS; METRONIDAZOLE; MK-0663; MK-0873; MK-8457; MK-8457 (free acid); MK-8457 100 mg; MK-8808; MK0359; MK0663, etoricoxib; MK0812; MK0812 / Duration of Treatment: 12 Weeks; MK0966; MK8457; MLN3897; MLTA3698A; MM-093; MONITOR; MOR103; MORAb-022; MORPHINE SULFATE; MP-435(dose1) + Methotrexate; MR Prednisone; MR prednisone; MRA; MRA (Tocilizumab); MRA (tocilizumab); MRA(Tocilizumab); MRA, Actemra; MRA-SC; MRC375; MRC375 150mg; MSB11022; MSB11456; MT203; MTRX1011A; MTX; MTX Goldshield Tablets; MTX HEXAL 2,5 mg Tabletten; MTX HEXAL 2,5mg Tabletten; MTX HEXAL Tablets; MTX plus anti-TNF; MTX start; MTX therapy; MabThera; MabThera (rituximab); MabThera 100mg; MabThera 500 mg; MabThera 500 mg (10 mg/ml) concentrate for solution for infusion; MabThera 500 mg (10mg/ml); MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung; MabThera 500 mg concentrate for solution for infusion; MabThera 500mg; MabThera infusions; MabThera/Rituxan; MabThera®; MabThera® (rituximab); MabThera®, 100 mg Concentrado para solución para perfusión; MabThera®, 100 mg concentrate for solution for infusion; MabionCD20; Mabthera; Mabthera (rituximab); Mabthera 500 mg Concentrate for solution for infusion; Magnesium; Manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome); Maraviroc; Masitinib; Masitinib (AB1010); Masitinib 3 mg; Masitinib 6.0 mg; Masitinib mesylate; Mavrilimumab; Mavrilimumab 10 mg; Mavrilimumab 100 mg; Mavrilimumab 150 mg; Mavrilimumab 30 mg; Mavrilimumab 50 mg; Maxtrex; Medium THC/medium CBD; Medrol; Medrol 4 mg tablets; Medrol A 16 mg tablets; Medrone; Mefloquine; Melatonin; Meloxicam; Meloxicam 0.125 mg/kg; Meloxicam 0.25 mg/kg; Meloxicam ampoule; Meloxicam oral suspension; Meloxicam tablet; Meriva; Mesalazine; Mesenchymal cell transplantation; Metex; Metex 10 mg/ml Injektionslösung, Fertigspritze; Metex 10mg Tabletten; Metex 2,5mg; Metex 2,5mg Tabletten; Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte; Metex 7,5mg Tabletten; Metex Pen; Metex®; Metex® 50 mg/ml Injektionslösung, Fertigspritze; Metformin; Metformin treatment; Metformin/CP-690,550; Metformine; Methorexate; Methotrexat; Methotrexat 2,5 mg Tabletten medac; Methotrexat HEXAL® 2,5 mg Tabletten; Methotrexat Lederle 2.5mg tablets; Methotrexate; Methotrexate 'Lederle' 2,5mg tablets; Methotrexate 'Lederle' 2.5mg Tablets; Methotrexate 'Lederle' Tablets; Methotrexate (MTX); Methotrexate (Metoject® prefilled pen); Methotrexate (stable dose); Methotrexate (tapering dose); Methotrexate + Infliximab; Methotrexate + Methylprednisolone; Methotrexate + biologic administration; Methotrexate + salazopyrine + hydroxychloroquine administration; Methotrexate - Amneal; Methotrexate - DAVA; Methotrexate - Delay; Methotrexate - Immediate; Methotrexate - etanercept - prednisolone arm; Methotrexate 10 mg; Methotrexate 10 mg tablets; Methotrexate 2.5 mg Tablets; Methotrexate 2.5 mg tablets; Methotrexate 2.5mg Tablets; Methotrexate 2.5mg Tablets BP; Methotrexate 50mg/ml solution for injection, pre-filled syringe; Methotrexate Disodium; Methotrexate Ebewe; Methotrexate Lederle 2.5 mg Tablets; Methotrexate Pfizer 2,5 mg tabletter; Methotrexate Placebo; Methotrexate Sodium; Methotrexate Sodium 2.5mg Tablets; Methotrexate Sodium Tablets 2.5 mg; Methotrexate Sodium Tablets 2.5mg; Methotrexate Sodium tablets 2.5mg; Methotrexate ``Lederle`` 2.5mg tablets; Methotrexate as methotrexate disodium; Methotrexate capsules; Methotrexate disodium; Methotrexate plus ENBREL or ENBREL alone; Methotrexate plus ERB-041 for 12 weeks; Methotrexate plus sulfasalazine; Methotrexate pre-filled pen; Methotrexate prefilled pen; Methotrexate prefilled syringe; Methotrexate sodium; Methotrexate sodium 2.5mg tablets; Methotrexate sodium tablets 2.5 mg; Methotrexate sodium tablets 2.5mg; Methotrexate tablets 2.5 mg; Methotrexate treatment; Methotrexate ® 2.5mg Tablets; Methotrexate(MTX); Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol; Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol.; Methotrexate(necessary); Methotrexate, Leucovorin and BMS-986142; Methotrexate,Adalimumab; Methotrexate-Lachema; Methotrexate-Sulfasalazine-Hydroxychloroquine; Methotrexate® 2.5 mg tablets; Methotrextate; Methoxsalen; Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-beta-Dribofuronamide; Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide; Methylaminopterin; Methylprednisolone; Methylprednisolone Sodium Succinate; Methylprednisone; Metoject; Metotab®; Metotrexat Orion; Metotrexato; Metotrexato Sodico; Metronidazol; Metronidazole; Mextrex; Micellar Paclitaxel for Injection; Microgynon® 30 (Oral contraceptive); Midazolam; Milnacipran; Minocycline; Minodronate; Minodronic acid; Misoprostol; Mizoribine; Modal; Montelukast; Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142; Morphine; Morphine Hexal; Morphinsulfat; Moxifloxacin; Multigrain powder (S); Mushroom; Mushroom extract; Mussel oil capsules; N-3 LC-PUFA; N.A.; NAMILUMAB; NC-503 (Anti-amyloidotic (AA) Agent); ND; NI-0101; NI-071; NNC 0109-0000-0012; NNC 0141-0000-0100; NNC 0142-0000-0002; NNC 0151-0000-0000; NNC 142-0002; NNC0109-0012; NNC0114-0000-0005; NNC0114-0006; NNC0142-0002; NNC0151-0000-0000; NNC0215-0384; NNC109-0012; NNC151-0000; NSAIDs; NSAIDs (permitted,not necessary); Na; Namilumab; Namilumab (MT203); Nanocort; Nanoparticulated Rebamipide; Naprosyn 500 mg; Naproxen; Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.); Naproxen 10 mg/kg; Naproxen 500 mg tablets (PN 200 minus omeprazole); Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.); Naproxen oral suspension; Naproxen sodium 550mg tablet; Nasopharyngeal swabs; Natalizumab; Natriumklorid 9mg/ml; Nerve block; New Formulation Etanercept; New formulation adalimumab; Niclosamide; Nimesulide; Nitric Oxide; Nitroglycerine; NiuBangZi pill; Nivolumab; No; Non-Biologic DMARDs; Non-anti-TNF biologics; Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD); Non-biologic anti-rheumatic drugs; Non-biological DMARD's; Non-biological DMARDs; Non-steroidal anti-inflammatory drug; Non-steroidal anti-inflammatory drug (NSAID); Non-steroidal anti-inflammatory drugs; Nonbiologic DMARDs of investigator's choice; None; None as of yet; Norethindrone; Normal Saline; Norspan; Null; Nulojix; OM 89.; OMALIZUMAB; ORENCIA; ORENCIA 125 mg solution for injection; ORENCIA 125 mg solution for injection in pre-filled syringe; ORENCIA 125 mg, solution injectable en seringue préremplie; ORENCIA 250 mg polvo para concentrado para sol. para perfusión; ORENCIA 250mg powder for concentrate for solution for infusion; ORENCIA Subcutaneous Injection; ORENCIA*IV 2FL 250MG+2SIR; OTILIMAB; OTL38; OXICODONE DC.IT; Observational study; Ocrelizumab; Ocrelizumab / rhuMAb 2H7; Ocrelizumab 500mg; Ocrelizumabu 200mg; Ocrelizumabu 50mg; Ofatumumab; Olikizumab; Olokizumab; Olokizumab 120 mg; Olokizumab 240 mg; Olokizumab 60 mg; Olokizumab 64 mg SC q2w; Olokizumab 64 mg SC q4w; Olokizumab 64mg q2w; Olokizumab 64mg q4w; Olokizumab q2w; Olokizumab q4w; Olumiant; Omalizumab; Omega-3; Omega-3 and Vitamin E supplementation; Omega-3 fatty acid; Omega3; Omegaven (10% fish-oil emulsion; Omeprazole; Oncoxin + Viusid; Open-label Abatacept; Open-label Adalimumab; Open-labelAdalimumabRescue; Oral; Oral Corticosteroids; Oral SCIO-469 capsule; Oral bovine type II collagen; Oral corticosteroids; Oral methotrexate; Orencia; Orencia (abatacept); Orencia 125 mg; Orencia abatacept; Originator; Originator (legacy) drug; Originator rituximab - Rituxan ® or MabThera ®; Orncia; Ortho-Novum® 1/35; Ortho-novum; Otelixizumab; Other Biologics; Other DMARDs; Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac; Other biological agent; Other: 18F-FDG; Other: 18F-GE-180; Other: Adalimumab; Other: Avise PG - Diagnostic test; Other: Baseline serum vitamin D level at or above 50 nmol/l; Other: Baseline serum vitamin D level below 50 nmol/l; Other: Dead Sea Solar and Water Treatment; Other: Determination of calcium intake by a dietician interview; Other: Dose reduction to 2mg/L; Other: Dose reduction to 5mg/L; Other: Dummy Tripterygium wilfordii Hook F (TwHF); Other: Exercise followed cold water immersion; Other: Gadobutrol; Other: Group 2 (DMARDS treated group); Other: Hand training; Other: Harkány medicinal water; Other: Healthy volunteers; Other: Hydroxychloroquine/Chloroquine; Other: Lab Work; Other: Losartan; Other: Metformin; Other: Methotrexate therapy; Other: Numerical rating scale; Other: Outpatient rheumatology department; Other: Plant-based diet; Other: QALCIMUM questionnaire; Other: Real-time data capture app; Other: Reduction group 1; Other: Reduction group 2; Other: Refered to general practice; Other: Resistance Exercise Program; Other: Simvastatin; Other: Sulfur Pool & Medicinal Mud; Other: Usual care; Other: Vegan Diet; Other: current treatment; Other: general population; Other: prednisone; Other: saline; Other: sterile saline; Otilimab; Otilimab (GSK3196165); Overencapsulated Prednisolone Tablets; Oxiklorin; Oxycodone; Oxycodone by patient-controlled analgesia (PCA); Oxygen; Ozoralizumab; P38 (4) Map Kinase Inhibitor; P38 Inhibitor (4); P38 Inhibitor (4) 150mg; P38 Inhibitor (4) 25mg; P38 Inhibitor (4) 300mg; P38 Inhibitor (4) 50mg; P38 Inhibitor (4) 75mg; P38 Map Kinase Inhibitor; P38(4) Map Kinase Inhibitor; PARACETAMOL; PARACETAMOLO DC.IT FU; PARALEN 500; PCA; PD 0360324; PDA001; PEG; PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE; PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE; PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE; PF-04171327; PF-04171327 10 mg; PF-04171327 25 mg; PF-05280586; PF-06410293; PF-06438179; PF-06650833; PF-06650833 100 mg; PF-06650833 20 mg; PF-06651600; PF-06835375; PG; PG-760564; PH-797804; PL 00095/5079R; PLA + MTX switched to ABA+ MTX, DB; PLA-695; PLX3397; PLX5622; PN 200 tablets (500 mg naproxen and 20 mg omeprazole); PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT); PNEUMOVAX® 23; PR-06410293; PRALIA 60 mg Subcutaneous Injection Syringe(denosumab); PRALIA 60mg Subcutaneous Injection Syringe(denosumab); PRD4862257; PREDNISOLONE; PREDNISONE; PRIMUS; PRO283698; PROPOFOL; PRTX-100; PRTX-100 at 1.5 mcg/kg; PRTX-100 at 12.0 mcg/kg; PRTX-100 at 240 mcg; PRTX-100 at 3.0 mcg/kg; PRTX-100 at 420 mcg; PRTX-100 at 6.0 mcg/kg; PS; Paclitaxel; Panax Quinquefolius; Pandemrix,; Paracetamol; Paracetamol (acetaminophen); Parecoxib; Paroxetine; Paroxetine & Prednisolone; Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP; Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP; Part A; Part B; Patient Current Care; Patient treated with DMARD; Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses; Peficitinib; Pegsunercept; Pegsunercept (PEG sTNF-RI); Pelubiprofen; Pelubiprofen 30 mg; Peri-neural Dexamethasone 1 mg; Permitted DMARDs; Persantin; Persantin 100 mg; Persantin 100 mg and; Pertactin; Pertactin adsorbed; Pertussis vaccine; Pharmacokinetics of certolizumab pegol; Phase 1: Conventiaonal DMARD; Phase 1: Etanercept; Phase 1: Methotrexate; Phase 2: Optional ETN, SSZ, HCQ, MTX; Phosphate; Piclidenoson; Pig whipworm eggs; Pioglitazone; Pirfenidone; Placebo; Plaebo; Plaquenil; Plaquenil 200 mg filmdrasjerte tabletter; Plasma analysis for bacterial translocation; Platelet Rich Plasma; Pneumo23 / Pneumovax; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F; Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; Pneumococcal polysaccharide vaccine; Pneumococcal serotypes; Pneumovax; Pneumovax 23; Potassium; Potassium supplement; Pravastatin; Pre-filled syringe; Pred; Pred + Meth; PredniHEXAL; PredniHEXAL® 10mg Tabletten; PredniHEXAL® 20mg Tabletten; PredniHEXAL® 5mg Tabletten; PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten; PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten; Predniso; Prednisolene tablets BP 1 mg; Prednisolon; Prednisolone; Prednisolone & dipyridamole; Prednisolone 20 mg; Prednisolone 40 mg; Prednisolone 5 mg; Prednisolone Labesfal; Prednisolone Tablets BP; Prednisolone Tablets BP 1 mg; Prednisolone Tablets USP 5 mg; Prednisolone-Dipyridamole; Prednison; Prednisona; Prednisone; Prednisone 1 mg; Prednisone 15 mg; Prednisone 2 mg; Prednisone 3 mg; Prednisone 4 mg; Prednisone 5 mg; Prednisone 7.5 mg; Prednisone Tablets USP, 1 mg; Prednisone Tablets USP, 5 mg; Pregabalin; Prevenar 13; Prevenar vaccination; Prevenar vaccine; Previously known as R935788; Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14; Procedure: Acupuncture; Procedure: Arthroscopic synovial tissue biopsy; Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: Blood Collection for PK Testing (15 Mins Before Injection); Procedure: Blood Collection for PK Testing (15 minutes post injection); Procedure: Blood Collection for PK Testing (18-20 hours post injection); Procedure: Blood Collection for PK Testing (180 minutes post injection); Procedure: Blood Collection for PK Testing (60 minutes post injection); Procedure: Blood Collection for PK Testing (after injection); Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Breast milk sampling; Procedure: Computed Tomography; Procedure: DEXA scan; Procedure: Exhaled nitric oxide assessment; Procedure: Extracorporeal Photopheresis; Procedure: FMT+MTX; Procedure: General anesthesia with tourniquet; Procedure: General anesthesia without tourniquet; Procedure: High frequency ultrasonography; Procedure: Implant Procedure; Procedure: Land exercises; Procedure: Planar Image with both Hands in Field of View; Procedure: Positron Emission Tomography; Procedure: Power doppler ultrasonography; Procedure: Quantiferon-TB Gold assay; Procedure: SPECT Imaging (180 Minutes post-injection); Procedure: SPECT Imaging (60 Minutes post-injection); Procedure: Spinal anesthesia with tourniquet; Procedure: Spinal anesthesia without tourniquet; Procedure: Synovial biopsy; Procedure: Tuberculin skin test; Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.; Procedure: Water exercises; Procedure: Whole body Protein turnover; Procedure: Whole body planar SPECT imaging (15 Minutes post-injection); Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection); Procedure: Whole body planar SPECT imaging (180 Minutes post-injection); Procedure: Whole body planar SPECT imaging (60 Minutes post-injection); Procedure: intra-articular injection of etanercept; Procedure: intra-articular injection of steroid; Progressive spacing of TNF-blocker injections; Propofol; Propolipid; Proposed INN - FILGOTINIB; Propsoed INN - FILGOTINIB; Protein; Puerarin; Puerarin injection 400 mg; Puerarin tablet 50 mg; QAL964; Qing Re Huo Xue (QRHX); Qingkailing injection 40 ml; Quensyl; R788; R788 Sodium, R788 Na, R788; R788 sodium hexahydrate, RIG2-01, RIG-G; R935788; RAYOS (delayed-release prednisone); RC18 160 mg plus MTX; RECOMBINANT FACTOR FC FUSION PROTEIN; REGN88; REMICADE; REMICADE 100 mg polvo para concentrado para solución para perfusión; REMICADE*EV F 100MG+F 2ML; REMICADE® (Infliximab); REMSIMA; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RGB-03; RITUXIMAB; RO 001-9265/F02-01; RO 487-7533; RO 496-4913; RO 496-4913/F03; RO 551-6922; RO-496-4913; RO001-9265/F04; RO0029893; RO045-2294; RO04877533; RO04877533/F05/F04; RO0506997; RO4402257; RO452294/V02; RO487-7533/F01-F05; RO487-7533/F10-04; RO4877533; RO4877533 (TCZ); RO4877533/F01; RO4877533/F04-F05; RO496-4913; RO7010939; RO7123520; RO7123520/F03-01; ROACTEMRA; ROACTEMRA 20 mg/ml, concentrado para solución para perfusión; RTNV148B IgG; RWJ-445380 100 mg; RWJ-445380 200 mg; RWJ-445380 300 mg; RWJ-445380 Capsules 50 mg; RWJ-445380 capsule 100 mg; RWJ-445380 capsules 150 mg; RWJ-445380-002; RYR; Radiation: Fluorine F 18 Clofarabine; Radiation: Stress myocardial perfusion PET; Radiofrequency; Raloxifene; Raloxifene hydrochloride; Ramelteon; Ramipril; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Rebamipide; Recombinant TNF-a receptor: IgG Fc fusion protein; Recombinant human Mab of IgG4 subtype; Recombinant human anti IL-22 monoclonal antibody IgG1; Recombinant human monoclonal antibody; Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class; Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class; Recombinant humanised anti-human monoclonal antibody directed against the IL-6R; Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal; Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody; Recombinant humanized anti-human Interleukin-6; Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Reditux; Remicade; Remicade (infliximab); Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.; Remicade®; Remsima; Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Repository corticotropin injection; Response to anakinra associated with methotrexate; Response to infliximab associated with methotrexate; Reumatocept (etanercept); Revamilast; Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs); RhuMAb 2H7; RhuTNFR:Fc; RhumAb to Il-17A (IgG1-k-class); Rhustoxicodendron 30; Ribazen; Riboflavin; Rifampicin; Rimacalib; Risedronate; Ritumax®; Rituxan; Rituxan (INN: Rituximab), brand name in the US; Rituxan (INN: Rituximab), brand name in the United States; Rituxan (US, Canada, Japan), MabThera (rest of the world); Rituxan®; Rituxan® (rituximab); Rituximab; Rituximab (EU); Rituximab (US); Rituximab - MabThera; Rituximab MabThera; Rituximab [MabThera/Rituxan]; Rituximab [MabThera]; Rituximab [Mabthera/Rituxan]; Rituximab, MTX, folic acid; Rituximab, observational study amon patients with active RA; Rituximab-EU+ Rituximab-Pfizer x 2 Courses; Rituximab-Pfizer; Rituximab-Pfizer (PF-05280586) x 3 courses; Rituximab-US + Rituximab-Pfizer x 2 Courses; Rivaroxaban; Rixathon; Ro 002-9893/F02; Ro 45-2294; Ro 48-77533; Ro 487-7533; Ro 487-7533/F01; Ro 487-7533/F10; Ro 487-7533/F10-02; Ro 487-7533/F10-04; Ro 496-4913; Ro Actemra; Ro-Actemra; Ro487-7533; RoACTEMRA; RoActemra; RoActemra (R); RoActemra 162 mg; RoActemra 162 mg solution injectable en seringue préremplie; RoActemra 20 mg/ml Concentrate for solution for infusion; RoActemra 20 mg/ml concentrado para solución para perfusión; RoActemra 20 mg/ml concentrate for solution for infusion.; RoActemra(R); RoActemra®; RoActemra®EV Product Code: PRD82321; RoActerma; RoActmera; Roactemra; Rob 803; Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali; Rob 803 (capsules 12.5 mg); Rob 803 (capsules 15 mg); Rob 803 (capsules 25 mg); Rob 803 (capsules 6.25 mg); Rob 803 12.5mg capsule; Rob 803 15mg capsule; Rob 803 25mg capsule; Rob 803 6.25mg capsule; Rob 803 6.5mg capsule; Rofecoxib; Romosozumab; Ropivacaine; Rosiglitazone; Rosiglitazone Extended Release Tablets; Rosiglitazone XR; Rosiglitazone maleate; Rosuvastatin; Roxithromycin; Rupatadine; S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide; S.c. injections of bovine intestinal Alkaline Phosphatase; S1; SAIT101; SAIT101 (proposed rituximab biosimilar); SAIT101 (rituximab biosimilar); SAN-300; SANDIMMUN NEORAL*30CPS 100MG; SANDIMMUN NEORAL*50CPS 25MG; SAR153191; SAR153191 (REGN88); SARILUMAB; SB 681323; SB-681323; SB-681323 Tablets; SB-681323 oral tablets; SB2; SB2 (infliximab biosimilar); SB2 (proposed biosimilar to infliximab); SB4; SB4 (etanercept biosimilar); SB4 (proposed biosimilar to etanercept); SB5; SB5 (proposed biosimilar to adalimumab); SBI-087; SC golimumab; SC12267; SC12267 (4SC-101); SCH 900259; SCH900259; SCIO-469; SD-QIV; SECUKINUMAB; SHR0302; SIMPONI; SIMPONI 50 mg solución inyectable en pluma precargada; SKI-O-703; SKI-O-703 capsule; SM03; SMP-114; SODIUM CHLORIDE; SSR150106; SSR150106XB; STA 5326 mesylate; STNF-R1; SULFASALAZINE; Salazopyrin; Salazopyrin EN; Salazopyrin EN 500 mg enterotabletter; Salazopyrin EN-Tabs; Salazopyrin En-Tabs; Salazopyrine; Salazosulfapyridine; Sar; Sarilumab; Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]; Sarilumab SAR153191 (REGN88); Seasonal Influenza vaccine; Seasonal influenza vaccine; Secukinmab; Secukinumab; Secukinumab (AIN457); See D.3.9.3 'Other descriptive name' below; Shingrix; Sildenafil; Simponi; Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.; Simponi®; Simvastatin; Simvastatin 20 mg; Sirolimus; Sirukuma; Sirukumab; Sirukumab 100 mg; Sirukumab 50 mg; Sodium aurothiomalate; Sodium aurothiomalate (intramuscular gold); Sodium chloride; Sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate; Sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate; Solu-Medrone 125mg; Solu-Medrone 2 Gram; Solu-Medrone 2mg; Somatropin; Somatropin [rDNA origin] for injection; Stable weekly dose of methotrexate; Standard DMARDs (Disease Modifying Anti Rheumatic Drugs); Standard of Care; Statins; Stem Cell Transplantation; Steroids; Stool analysis; Stools; Subcutaneous (SC) Abatacept; Subcutaneous (SC) abatacept; Subcutaneous Abatacept; Subcutaneous tocilizumab; Subcutaneous(SC) Abatacept; Subcutanious administration; Sublingual nitroglycerine; Sulfasalazine; Sulfate; Sulphasalazine; Sulphasalazine + Hydroxychloroquine OR Prednisolone; Sunflower oil; Suspension IR; Synovial biopsy; Synthetic DMARD(s); Systemic non-biological treatments; T-614; T0001; TA-650 (Infliximab); TA-650 10 mg/kg; TA-650 3 mg/kg; TA-650 6 mg/kg; TAB08; TABALUMAB; TACI - FC5; TACI-Fc5; TAK-715; TAK-715 and methotrexate; TAK-783; TAK-783 and methotrexate; TAS5315 high dose; TAS5315 low dose; TBE-vaccine; TC99m-tilmanocept; TDMARDs; TETANUS TOXOID; THA; THC; TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED); TILMANOCEPT; TJ003234 injection; TL011; TL011, anti CD20, for the treatment of rheumatoid arthritis; TMI-005; TMI-005 (WAY-177005); TMI-005 WAY-177005; TNF Antagonist (enbrel, humire, remicade, cimzia, symponi); TNF Inhibitor; TNF alpha blockers; TNF alpha inhibitors; TNF antagonist; TNF blockers (infliximab, adalimumab, etanercept); TNF blockers monotherapy; TNF inhibitor/TCZ; TNF inhibitors; TNF kinoid; TNF start; TNF-K; TNF-Kinoid; TNF-a antagonists, non-TNFs, DMARD non-biologics; TNF-a inhibitor OR JAK inhibitor; TNF-alpha Inhibitor; TNF-alpha antagonist and other biotherapy; TNF-alpha antagonists; TNF-blockers suspension in patients with rheumatoid arthritis; TNFR:Fc; TNFa Kinoid; TNR-001; TOCILIZUMAB; TOCILIZUMAB SC; TOFACITINIB; TOFACITINIB CITRATE; TOFACITINIB CITRATE CP-690550; TRIAMCINOLONACETONID; TRIAMCINOLONACETONID EP; TRIAMCINOLONE ACETONIDE; TRU-015; TS-152; TSO; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Tacrolimus (Prograf®); Tacrolimus with Methotrexate; Tasocitinib; Tasocitinib (proposed INN); Tasocitinib citrate; Tasocitinib plus Methotrexate; Tc 99m tilmanocept; Tc99m-tilmanocept; Tea; Technetium Tc 99m; Technetium Tc 99m Tilmanocept; Technetium Tc 99m tilmanocept; Teriparatide; Tetanus + pnemococcal vaccines alone; Tetanus Toxoid Adsorbed Vaccine; Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed); Tetanus toxoid; Tetanus toxoid adsorbed; Tetanus toxoid adsorbed booster vaccine; Tetraccycline; Tetraccycline-hydrochloride; Tetracycline; Tetrandrine; The effectiveness of Xeljanz in rheumatoid arthritis patients; Therapy with disease-modifying anti rheumatic drugs (DMARD); Ticagrelor; Tilmanocept; Tirabrutinib; Titan; To be confirmed; Tocilizumab; Tocilizumab (Actemra or RoActemra); Tocilizumab (Actemra); Tocilizumab (Actemra®); Tocilizumab (TCZ); Tocilizumab + methotrexate(MTX); Tocilizumab 162 mg; Tocilizumab 162mg/0.9ml SC PFS SC; Tocilizumab 162mg/0.9ml jeringa SC; Tocilizumab 162mg/0.9ml syringe SC; Tocilizumab IV; Tocilizumab Prefilled Syringe; Tocilizumab Roche; Tocilizumab SC; Tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI); Tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tocilizumab [RoActemra]; Tocilizumab plus methotrexate; Tocilizumab+Methotrexate(MTX); Tocilizumab, Abatacept; Tocilizumabum; Tofacitinb; Tofacitinib; Tofacitinib (Xeljanz); Tofacitinib (Xeljanz®); Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet; Tofacitinib 5 MG [Xeljanz]; Tofacitinib 5 mg; Tofacitinib 5mg po bid; Tofacitinib citate (Phase III formulation); Tofacitinib citrate; Tofacitinib citrate (Phase III formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercial formulation- debossed); Tofacitinib citrate (clinical trial image); Tofacitinib citrate (commercial image); Tofacitinib citrate( Phase III formulation); Tofacitinib or Baricitinib; Tofacitinib with methotrexate; Tofacitinib without methotrexate; Tofacitinib/baricitinib; TolDC; Tolerogenic dendritic cells; Tolicizumab; Tolicizumab Roche; Topical compound tripterygium; Topical tripterygium gel; Traditional antirheumatic drugs; Tramadol; Tramadol hydrochloride + acetaminophen; Tranexamic acid; Tranilast; Treat to target; Treatment A; Treatment B; Treatment C; Treatment I; Treatment II; Treatment III; Treatment of MTX; Treatment of MTX and HCQ; Treatment of MTX and TwHF; Treatment of TCM; Treatment of TwHF; Tregalizumab; Trexan; Trexan+Salazopyrin+Oxiklorin+prednisolone; Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab; Triam 40 mg Lichtenstein; Triamcinolone; Triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip); Triamcinolone acetonide; Triamcinolone hexacetonid (Lederspan); Triamcinolone hexacetonide; Triamcinolone hexacetonide (Lederspan); Trichuris suis ova; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii Hook F; Tripterygium wilfordii Hook F (TwHF); Trivalent inactivated influenza vaccine; Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab); Tumor Necrosis Factor Inhibitors; TwHF; UC-MSC+DMARDS; UC-MSCs; UCB4940; UK-427,857; US-licensed Humira®; UVADEX; UVEDOSE; Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs); Umbilical cord mesenchymal stem cells; Upadacitinib; Upadacitinib 12mg; Upadacitinib 15mg; Upadacitinib 30mg; Upadacitinib 3mg; Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level; Ustekinumab; Ustekinumab + MTX (Group 2); Ustekinumab + MTX (Group 3); Uvadex; VAY736; VIB4920; VX-509; VX-702; Vaccination against TBE; Valdecoxib; Vancomycin; Varicella Zoster Vaccine; Velcade; Velcade®; Veltuzumab; Veltuzumab solution 75mg/ml; Venlafaxine; Venlafaxine Hydrochloride; Venous blood sample; Vidofludimus; Vitamin D; Vitamin D in arm B; Vitamin D3; Vitamin E; Vitamin K; Voltarol; Voltarol SR; Voltarol SR (generics also available in the EU); Voltrarol SR; WAY-177005; Warfarin; Warfarin+ Vitamin K; Water; Whale blubber oil; Whey Protein&Prebiotic Supplement; XELJANZ; XELJANZ 5 mg film-coated tablets; XELJANZ 5Mg Tablet; XENP5871; XOMA 052; Xeljanz; Xeljanz 5mg; Xinfeng capsule; XmAb5871_0.3MG; XmAb5871_1.0MG; XmAb5871_10.0MG; XmAb5871_3.0MG; XmAb®5871; Xolair; YLB113; YRA-1909 high dose; YRA-1909 low dose; YRA-1909 mid dose; Yellow Fever Vaccine; Yellow Fever vaccine (17D); Yisaipu; Z102; Z102 (Prednisolone and Dipyridamole).; ZD 4522; ZOLEDRONIC ACID; Zoledronate; Zoledronic Acid; Zoledronic acid; Zolpidem; Zostavax; Zostavax (varicella zoster virus) vaccine; Zostavax vaccine; Zostavax®; [18F]PEG-Folate; [BMS-188667]; [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04117165 (ClinicalTrials.gov)	March 1, 2021	30/9/2019	Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis	Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)	Arthritis, Rheumatoid;Biological Therapy	Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care	University Hospital, Grenoble	NULL	Not yet recruiting	18 Years	70 Years	All	180	N/A	France
2	ChiCTR2000036094	2021-01-01	2020-08-21	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage	Rheumatoid Arthritis	Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;	Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Pending	18	70	Both	Experimental group:60;Control group:60;		China
3	JPRN-jRCTs071200007	01/01/2021	20/04/2020	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
4	NCT04196868 (ClinicalTrials.gov)	December 3, 2020	5/12/2019	Methotrexate and Metformin in Rheumatoid Arthritis Patients	Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients	Arthritis, Rheumatoid	Drug: Metformin treatment;Other: Placebo;Drug: Methotrexate treatment	University Hospital, Bordeaux	Ministry for Health and Solidarity, France	Recruiting	18 Years	N/A	All	128	Phase 2	France
5	NCT04559412 (ClinicalTrials.gov)	December 2020	3/9/2020	Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis	Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Device: Sofusa DoseConnect;Drug: Enbrel	Sorrento Therapeutics, Inc.	NULL	Not yet recruiting	18 Years	75 Years	All	10	Phase 1	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT04292067 (ClinicalTrials.gov)	November 23, 2020	26/2/2020	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Spondyloarthritis;Rheumatoid Arthritis	Biological: Faecal sampling	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	400		France
7	JPRN-jRCTs071200054	18/11/2020	18/11/2020	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	40	Phase 4	Japan
8	EUCTR2019-000878-30-BE (EUCTR)	18/11/2020	21/09/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
9	NCT04608344 (ClinicalTrials.gov)	November 4, 2020	23/10/2020	Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	Rheumatoid Arthritis	Drug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: Filgotinib	Gilead Sciences	Galapagos NV	Recruiting	18 Years	55 Years	All	30	Phase 1	United States
10	NCT04470453 (ClinicalTrials.gov)	November 2020	9/7/2020	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug	Rheumatoid Arthritis	Biological: Blood sample;Diagnostic Test: CRQ	Centre Hospitalier Universitaire de Saint Etienne	NULL	Not yet recruiting	18 Years	N/A	All	60	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2020-000658-83-BG (EUCTR)	21/10/2020	07/10/2020	A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2	Poland;Ukraine;Georgia;Bulgaria
12	NCT04577781 (ClinicalTrials.gov)	October 12, 2020	30/9/2020	A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Arthritis, Rheumatoid	Drug: GLPG3970;Drug: Placebo	Galapagos NV	NULL	Recruiting	18 Years	64 Years	All	25	Phase 2	Georgia;Poland;Ukraine
13	NCT04311567 (ClinicalTrials.gov)	October 7, 2020	5/3/2020	Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease	Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial	Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD	Drug: Tofacitinib;Drug: Methotrexate	Vastra Gotaland Region	Göteborg University	Not yet recruiting	18 Years	80 Years	All	48	Phase 4	Sweden
14	EUCTR2019-002205-22-FR (EUCTR)	01/10/2020	13/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
15	NCT04586933 (ClinicalTrials.gov)	October 2020	22/9/2020	Nutrition in Rheumatic Diseases	Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance	Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis	Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance	Haukeland University Hospital	GC Rieber Oils AS	Not yet recruiting	18 Years	75 Years	All	120	N/A	Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT04638426 (ClinicalTrials.gov)	September 10, 2020	13/11/2020	Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis	For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)	Rheumatoid Arthritis	Drug: HL237 tablet;Drug: Placebo of HL237 tablet	Hanlim Pharm. Co., Ltd.	NULL	Enrolling by invitation	19 Years	N/A	All	196	Phase 2	Korea, Republic of
17	EUCTR2019-000878-30-BG (EUCTR)	04/09/2020	11/08/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
18	EUCTR2019-002676-14-BG (EUCTR)	20/08/2020	27/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
19	EUCTR2019-002205-22-DE (EUCTR)	12/08/2020	07/07/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
20	NCT04457856 (ClinicalTrials.gov)	August 6, 2020	28/6/2020	A Study of TJ003234 in Rheumatoid Arthritis Patients	A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Biological: TJ003234 injection	I-Mab Biopharma Co. Ltd.	NULL	Recruiting	18 Years	70 Years	All	63	Phase 1	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT04413617 (ClinicalTrials.gov)	July 29, 2020	19/5/2020	TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis	Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib	Pfizer	NULL	Recruiting	18 Years	70 Years	All	450	Phase 2	Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine
22	JPRN-jRCTs071190030	28/07/2020	11/10/2019	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
23	EUCTR2019-002676-14-CZ (EUCTR)	07/07/2020	11/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
24	EUCTR2019-002676-14-HU (EUCTR)	18/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
25	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
27	NCT04584541 (ClinicalTrials.gov)	June 11, 2020	10/6/2020	SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism	Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments	Spondyloarthritis;Rheumatoid Arthritis;Covid19	Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	150	N/A	France
28	EUCTR2019-002676-14-SE (EUCTR)	01/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
29	EUCTR2019-001185-15-BG (EUCTR)	29/05/2020	15/05/2020	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
30	NCT04333147 (ClinicalTrials.gov)	May 12, 2020	27/3/2020	Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)	A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Otilimab (GSK3196165);Drug: csDMARD(s)	GlaxoSmithKline	Iqvia Pty Ltd	Recruiting	18 Years	N/A	All	2640	Phase 3	United States;Argentina;Canada;Czechia;Japan;Korea, Republic of;Latvia;Lithuania;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2019-002205-22-GB (EUCTR)	01/05/2020	07/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
32	NCT04350216 (ClinicalTrials.gov)	April 30, 2020	8/4/2020	Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)	Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Atherosclerosis	Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]	Instituto de Investigación Marqués de Valdecilla	NULL	Not yet recruiting	18 Years	100 Years	All	20	Phase 4	NULL
33	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
34	NCT04268771 (ClinicalTrials.gov)	April 8, 2020	31/1/2020	A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products	A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®	Dr. Reddy's Laboratories Limited	PPD	Recruiting	18 Years	N/A	All	140	Phase 3	United States
35	EUCTR2019-002205-22-ES (EUCTR)	06/04/2020	23/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2019-002205-22-PL (EUCTR)	29/03/2020	07/02/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
37	EUCTR2019-000878-30-HU (EUCTR)	26/03/2020	28/02/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany
38	NCT04389320 (ClinicalTrials.gov)	March 15, 2020	11/5/2020	Antimalarial and Covid 19 in Rheumatoid Arthritis	Antimalarial and Covid 19 in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Hydroxychloroquine	Assiut University	NULL	Completed	20 Years	70 Years	All	60		Egypt
39	EUCTR2019-003700-12-FR (EUCTR)	13/03/2020	04/06/2020	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug	rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	France
40	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	ChiCTR2000030400	2020-03-01	2020-03-01	Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia	Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia	Interstitial pneumonia	Case series:Tetrandrine;	The First People's Hospital of Yancheng	NULL	Recruiting	36	78	Both	Case series:41;		China
42	EUCTR2019-000878-30-CZ (EUCTR)	26/02/2020	06/01/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan
43	EUCTR2019-001185-15-NO (EUCTR)	19/02/2020	07/11/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Sweden
44	EUCTR2019-000878-30-LT (EUCTR)	13/02/2020	25/11/2019	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
45	EUCTR2019-000284-24-CZ (EUCTR)	03/02/2020	17/10/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 4	United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2018-004558-30-PT (EUCTR)	03/02/2020	21/05/2019	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Portugal;Spain
47	NCT04230213 (ClinicalTrials.gov)	January 13, 2020	14/1/2020	A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis	Drug: PF-06410293;Drug: adalimumab	Pfizer	NULL	Recruiting	18 Years	70 Years	All	420	Phase 3	United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine
48	EUCTR2019-004179-38-SE (EUCTR)	10/01/2020	19/11/2019	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA	Patients with early active rheumatoid arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Västra Götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	145	Phase 4	Sweden
49	NCT04186871 (ClinicalTrials.gov)	January 7, 2020	28/11/2019	Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis	Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome	Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	65 Years	All	185	Phase 2	United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
50	JPRN-UMIN000042632	2020/01/01	03/12/2020	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis	Rheumatoid arthritis	low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	34	Not applicable	Asia(except Japan)
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2019-000284-24-LT (EUCTR)	18/12/2019	07/11/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
52	EUCTR2018-004287-56-FR (EUCTR)	21/11/2019	31/01/2020	Methotrexate and Metformin in rheumatoid arthritis patients	Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2	rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		CHU de Bordeaux	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	128	Phase 2	France
53	EUCTR2019-001185-15-SE (EUCTR)	06/11/2019	01/07/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization). The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Moldova, Republic of;Sweden
54	NCT03194204 (ClinicalTrials.gov)	October 1, 2019	10/6/2017	Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial	Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Doxycycline Tablets	Assiut University	NULL	Completed	18 Years	60 Years	All	160	N/A	Egypt
55	ChiCTR1900026257	2019-09-28	2019-09-28	A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue	Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial	Rheumatoid arthritis (RA)	High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;	Zhejiang Provincal Hospital of TCM	NULL	Pending	18	70	Both	High-dose experimental group :30;Low-dose experimental group:30;Control group :30;	Phase 2	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	NCT03971253 (ClinicalTrials.gov)	September 2, 2019	30/5/2019	Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis	Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis	Rheumatoid Arthritis (RA)	Drug: Peficitinib	Astellas Pharma Inc	NULL	Recruiting	N/A	N/A	All	3000		Japan
57	JPRN-jRCTs071190001	29/08/2019	02/04/2019	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study	Rheumatoid arthritis	Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study. Control group combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation. Intervention group monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation. The discontinuation criteria for the study are as follows: 1) When subjects requested to discontinue the treatment 2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events 3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study 4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits 5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above	Miyazaki Yusuke	Tanaka Yoshiya	Recruiting	>= 16age old	Not applicable	Both	150	Phase 4	Japan
58	JPRN-JapicCTI-194928	26/8/2019	22/08/2019	-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	Rheumatoid Arthritis	Intervention name : methotrexate INN of the intervention : methotrexate Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg. Control intervention name : methotrexate INN of the control intervention : methotrexate Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.	medac GmbH	NULL	complete	20	75	BOTH	100	Phase 3	Japan
59	NCT04068246 (ClinicalTrials.gov)	August 1, 2019	21/8/2019	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.	Rheumatoid Arthritis	Drug: Metformin;Drug: Placebo	Sadat City University	NULL	Recruiting	18 Years	N/A	All	150	Early Phase 1	Egypt
60	NCT04464642 (ClinicalTrials.gov)	July 10, 2019	6/7/2020	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tofacitinib	Dr. Mohammad Mamun Khan	NULL	Active, not recruiting	18 Years	N/A	All	110	Phase 4	Bangladesh
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	NCT03912428 (ClinicalTrials.gov)	June 14, 2019	10/4/2019	Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Myositis	Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176	National Institute of Mental Health (NIMH)	NULL	Recruiting	18 Years	N/A	All	86	Phase 4	United States
62	EUCTR2018-003877-91-DE (EUCTR)	13/06/2019	26/02/2019	B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy	Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA	Active rheumatoid arthritis with ACPA antibodies failing methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	INN or Proposed INN: RITUXIMAB Trade Name: Orencia INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
63	EUCTR2019-001185-15-DK (EUCTR)	06/06/2019	12/04/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Sweden
64	NCT04344405 (ClinicalTrials.gov)	June 1, 2019	9/4/2020	Vitamin D as a Key Player in Rheumatoid Arthritis	Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response	the Immunomodulatory Effect	Drug: Vitamin D;Drug: Placebo	Assiut University	NULL	Recruiting	20 Years	70 Years	All	60	Phase 3	Egypt
65	EUCTR2018-004558-30-ES (EUCTR)	16/05/2019	11/04/2019	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2018-002306-31-GB (EUCTR)	15/05/2019	14/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom
67	EUCTR2018-002306-31-BE (EUCTR)	30/04/2019	07/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom
68	EUCTR2018-002306-31-ES (EUCTR)	04/04/2019	12/04/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
69	NCT03700021 (ClinicalTrials.gov)	April 2019	2/10/2018	Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis	Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Abatacept + csDMARD	New York University School of Medicine	NULL	Not yet recruiting	18 Years	N/A	All	25	Phase 4	United States
70	NCT03890302 (ClinicalTrials.gov)	March 14, 2019	25/3/2019	Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A	A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A	Rheumatoid Arthritis	Drug: FB704A;Drug: Placebo	Fountain Biopharma Inc.	Oneness Biotech Co., Ltd.	Completed	18 Years	55 Years	All	31	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2018-002306-31-HU (EUCTR)	08/03/2019	11/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom
72	NCT03813771 (ClinicalTrials.gov)	March 2019	12/9/2018	Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification	Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.	Rheumatoid Arthritis	Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine	University of Leeds	Samsung Bioepis Co., Ltd.	Not yet recruiting	18 Years	N/A	All	106	Phase 4	United Kingdom
73	NCT03852355 (ClinicalTrials.gov)	February 25, 2019	22/2/2019	the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis	the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial	Rheumatoid Arthritis;Headache	Drug: Radiofrequency;Drug: Steroids	Assiut University	NULL	Completed	18 Years	60 Years	All	60	N/A	Egypt
74	EUCTR2018-000666-10-BE (EUCTR)	19/02/2019	16/11/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom
75	NCT03737708 (ClinicalTrials.gov)	February 13, 2019	8/11/2018	A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)	Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial	Rheumatoid Arthritis (RA)	Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept	Astellas Pharma Korea, Inc.	NULL	Completed	19 Years	75 Years	All	22	Phase 4	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2018-000666-10-ES (EUCTR)	23/01/2019	22/01/2019	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
77	EUCTR2018-000666-10-HU (EUCTR)	03/01/2019	29/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
78	NCT03574545 (ClinicalTrials.gov)	December 19, 2018	21/6/2018	Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: ianalumab	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	65 Years	All	50	Phase 1	Germany;Jordan
79	EUCTR2018-000666-10-GB (EUCTR)	17/12/2018	24/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
80	EUCTR2017-004226-15-DK (EUCTR)	26/10/2018	05/01/2018	Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.	CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art	Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		King Christian 10th Hospital for Rheumatology	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	NCT03660059 (ClinicalTrials.gov)	September 27, 2018	26/8/2018	A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)	A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX	Rheumatoid Arthritis (RA)	Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)	Astellas Pharma China, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	385	Phase 3	China;Korea, Republic of;Taiwan
82	NCT03691909 (ClinicalTrials.gov)	September 25, 2018	27/9/2018	A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis	A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: HB-adMSCs	Hope Biosciences	NULL	Completed	18 Years	65 Years	All	15	Phase 1;Phase 2	United States
83	NCT03699293 (ClinicalTrials.gov)	September 22, 2018	21/9/2018	NSAIDs vs. Coxibs in the Presence of Aspirin	NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease	Rheumatoid Arthritis;Cardiovascular Diseases	Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet	Inova Health Care Services	NULL	Unknown status	18 Years	75 Years	All	30	Phase 4	United States
84	NCT04056039 (ClinicalTrials.gov)	August 14, 2018	21/6/2019	Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.	Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.	Cardiovascular Diseases;Arthritis, Rheumatoid	Drug: Atorvastatin;Drug: Colchicine	Hospital Central Dr. Ignacio Morones Prieto	NULL	Completed	18 Years	N/A	All	60	Phase 2	Mexico
85	EUCTR2018-002368-18-ES (EUCTR)	25/07/2018	25/07/2018	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO ® 40 micrograms Product Code: HBVAXPRO ® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)	FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	740	Phase 4	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	NCT03445871 (ClinicalTrials.gov)	July 2, 2018	20/2/2018	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate	Rheumatoid Arthritis	Biological: Blood sample;Diagnostic Test: CRQ	Centre Hospitalier Universitaire de Saint Etienne	NULL	Completed	18 Years	N/A	All	60	Phase 4	France
87	EUCTR2016-002344-16-GB (EUCTR)	28/06/2018	29/11/2017	Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.	Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University of Leeds	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	106	Phase 4	United Kingdom
88	NCT03084419 (ClinicalTrials.gov)	June 26, 2018	7/3/2017	APRIL (AbatacePt in Rheumatoid Arthritis-ILD)	Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial	Rheumatoid Arthritis;Interstitial Lung Disease	Drug: Abatacept	Cambridge University Hospitals NHS Foundation Trust	Bristol-Myers Squibb	Recruiting	18 Years	N/A	All	30	Phase 2	United Kingdom
89	NCT03535402 (ClinicalTrials.gov)	June 1, 2018	9/5/2018	Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics	Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.	Rheumatoid Arthritis	Drug: Sarilumab	Gaylis, Norman B., M.D.	NULL	Active, not recruiting	18 Years	N/A	All	20	Phase 3	United States
90	EUCTR2017-001944-36-ES (EUCTR)	21/05/2018	10/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	137	Phase 1;Phase 2	United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT03492658 (ClinicalTrials.gov)	May 17, 2018	3/4/2018	Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)	Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).	Rheumatoid Arthritis;Rheumatic Diseases	Drug: Abatacept;Drug: Methotrexate	Leiden University Medical Center	NULL	Recruiting	18 Years	N/A	All	46	Phase 4	Netherlands
92	EUCTR2016-002569-68-GB (EUCTR)	04/05/2018	18/05/2018	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL	Rheumatoid-associated Interstitial Lung Disease (RA-ILD) MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	United Kingdom
93	JPRN-UMIN000030584	2018/04/18	27/12/2017	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis	Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1). Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated. Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage	Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine	Eisai Co., Ltd.	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	300	Not selected	Japan,Asia(except Japan)
94	JPRN-jRCT1031180088	18/04/2018	18/01/2019	MIRACLE Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis Rheumatoid Arthritis	Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period). To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle. If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1). If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week. Subjects in whom MTX at a dosage >=	Kaneko Yuko	Eisai Co., Ltd.	Not Recruiting	>= 18age old	Not applicable	Both	300	Phase 4	South Korea;Taiwan;Japan
95	NCT03505008 (ClinicalTrials.gov)	April 18, 2018	16/4/2018	Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan	MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Adalimumab	Keio University	Eisai Co., Ltd.	Active, not recruiting	18 Years	N/A	All	300	Phase 4	Japan;Korea, Republic of;Taiwan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	JPRN-jRCTs071180018	13/04/2018	15/02/2019	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.	Rheumatoid arthritis	Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.	Kawakami Atsushi	Nakagaki Hisashi;Daiichi Sankyo co.,LTD.	Not Recruiting	>= 20age old	Not applicable	Both	44	Phase 4	Japan
97	JPRN-UMIN000030575	2018/03/31	26/12/2017	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Rheumatoid arthritis	Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.	Daiichi Sankyo Company, Limited	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	44	Not applicable	Japan
98	EUCTR2017-001944-36-BG (EUCTR)	13/03/2018	24/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: N/A Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
99	ChiCTR1800014584	2018-03-01	2018-01-22	Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.	Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.	Knee osteoartritis;Rheumatoid arthritis	Experimental group:Asprin;Controlled group:Rivaroxaban;	Department of Orthopaedics, West China Hospital, Sichuan University	NULL	Pending	70	100	Both	Experimental group:90;Controlled group:30;		China
100	EUCTR2017-004348-39-FR (EUCTR)	15/02/2018	16/01/2018	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU	rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: methotrexate Product Code: 1	CHU Saint-Etienne	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2016-003630-25-NL (EUCTR)	08/02/2018	06/09/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
102	EUCTR2017-002878-38-NL (EUCTR)	07/02/2018	12/09/2017	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA	Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia 125 mg INN or Proposed INN: ABATACEPT	Leiden University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	46	Phase 4	Netherlands
103	NCT04022525 (ClinicalTrials.gov)	February 1, 2018	15/7/2019	Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches	Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches	Rheumatoid Arthritis	Drug: Leflunomide 20Mg Tab	Assiut University	NULL	Completed	18 Years	N/A	All	80		Egypt
104	NCT01694693 (ClinicalTrials.gov)	January 31, 2018	24/9/2012	Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study	Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study	Rheumatoid Arthritis	Drug: Orencia	Bristol-Myers Squibb	NULL	Withdrawn	18 Years	N/A	All	0	N/A	NULL
105	NCT03368235 (ClinicalTrials.gov)	January 18, 2018	3/11/2017	Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: AZD9567;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	80 Years	All	21	Phase 2	Netherlands;Sweden;Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	NCT04312815 (ClinicalTrials.gov)	December 28, 2017	16/3/2020	A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX	A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate	Rheumatoid Arthritis(RA)	Drug: SM03;Drug: Placebo;Drug: MTX	SinoMab Pty Ltd	NULL	Recruiting	18 Years	70 Years	All	510	Phase 3	China
107	EUCTR2014-000555-93-ES (EUCTR)	18/12/2017	10/10/2017	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 3	Czech Republic;Brazil;Spain;Germany
108	EUCTR2017-001944-36-PL (EUCTR)	23/11/2017	11/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG 592 INN or Proposed INN: AMG592 Other descriptive name: AMG592	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
109	EUCTR2017-000838-64-NL (EUCTR)	10/11/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
110	NCT03329885 (ClinicalTrials.gov)	November 2, 2017	31/10/2017	A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis	A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis	Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis	Drug: BMS-986251;Other: Placebo	Bristol-Myers Squibb	NULL	Terminated	18 Years	70 Years	All	38	Phase 1;Phase 2	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	JPRN-UMIN000029759	2017/11/01	01/11/2017	Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial		Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	32	Not selected	Japan
112	EUCTR2016-002126-36-IT (EUCTR)	26/10/2017	31/01/2018	A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01	F. Hoffmann - Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
113	EUCTR2017-000149-30-GB (EUCTR)	25/10/2017	05/09/2017	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1	Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]		University Hospitals of Leicester NHS Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Canada;Australia;United Kingdom
114	JPRN-UMIN000029003	2017/10/01	05/09/2017	Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial		Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty No percutaneous periarticular analgesic injection at one day after total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
115	NCT03257852 (ClinicalTrials.gov)	September 29, 2017	20/8/2017	A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate	A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate	Rheumatoid Arthritis (RA)	Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy	Astellas Pharma Inc	NULL	Completed	20 Years	N/A	All	66	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	NCT03312465 (ClinicalTrials.gov)	September 28, 2017	12/10/2017	Anatomical Shoulder Domelock System Study	Anatomical Shoulder™ Domelock System A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study	Advanced Wear and Tear of the Shoulder Joint;Avascular Necrosis;Conditions Consequent to Earlier Operations;Omarthrosis;Rheumatoid Arthritis;Revision of Shoulder Prosthesis	Device: AS Domelock System	Zimmer Biomet	NULL	Recruiting	18 Years	80 Years	All	123		Belgium;Germany;Switzerland;United Kingdom
117	EUCTR2017-000838-64-SE (EUCTR)	11/09/2017	19/05/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
118	NCT04177173 (ClinicalTrials.gov)	September 1, 2017	7/4/2019	Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis	Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.	Arthritis, Rheumatoid	Drug: Simvastatin 20 mg;Drug: Methotrexate 10 mg	King Edward Medical University	NULL	Completed	18 Years	N/A	All	100	Phase 4	Pakistan
119	NCT03254966 (ClinicalTrials.gov)	September 2017	15/8/2017	Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients	Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: SHR0302;Drug: Placebo	Jiangsu HengRui Medicine Co., Ltd.	NULL	Not yet recruiting	18 Years	70 Years	All	170	Phase 2	China
120	EUCTR2017-000838-64-DK (EUCTR)	25/08/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2017-000947-41-FR (EUCTR)	18/08/2017	21/06/2017	ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.	ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR	Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie	Groupement des Hôpitaux de l’Institut Catholique de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	France
122	EUCTR2016-003630-25-DE (EUCTR)	14/08/2017	13/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
123	NCT03156023 (ClinicalTrials.gov)	August 14, 2017	15/5/2017	Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis	A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: AMG 570;Drug: Placebo	Amgen	NULL	Completed	18 Years	75 Years	All	34	Phase 1	United States;Germany
124	EUCTR2013-005543-90-EE (EUCTR)	07/08/2017	02/06/2017	This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
125	NCT03155347 (ClinicalTrials.gov)	August 2, 2017	15/5/2017	An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	70 Years	All	340	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2016-003630-25-BE (EUCTR)	01/08/2017	12/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
127	EUCTR2016-002126-36-ES (EUCTR)	31/07/2017	02/06/2017	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
128	EUCTR2016-003630-25-GB (EUCTR)	19/07/2017	15/08/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
129	EUCTR2016-000569-21-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
130	EUCTR2016-000568-41-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	JPRN-jRCT2071200057	08/07/2017	25/11/2020	Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study	A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study	Rheumatoid arthritis;D001172	Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug	Yazawa Rie	NULL	Complete	>= 20age old	< 45age old	Male	130	Phase 1	Japan
132	NCT03394131 (ClinicalTrials.gov)	July 1, 2017	25/12/2017	?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients	Treatment of Carpal Tunnel in Rheumatoid Arthritis	Treatment Resistant Carpal Tunnel in RA Patients	Drug: Hylase;Drug: Insulin;Other: saline	Assiut University	NULL	Unknown status	20 Years	80 Years	All	90	N/A	Egypt
133	NCT03278470 (ClinicalTrials.gov)	June 26, 2017	7/9/2017	A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject	A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject	Rheumatoid Arthritis	Drug: HL237;Drug: Placebo Oral Tablet	Hanlim Pharm. Co., Ltd.	NULL	Completed	20 Years	45 Years	Male	57	Phase 1	Korea, Republic of
134	EUCTR2016-003630-25-SK (EUCTR)	15/06/2017	04/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3068	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
135	EUCTR2016-003630-25-ES (EUCTR)	09/06/2017	09/06/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2016-000569-21-FR (EUCTR)	08/06/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
137	EUCTR2016-003630-25-PL (EUCTR)	07/06/2017	24/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
138	EUCTR2016-002337-30-HR (EUCTR)	05/06/2017	12/09/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
139	EUCTR2016-003630-25-HU (EUCTR)	29/05/2017	12/04/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong
140	EUCTR2016-002337-30-DE (EUCTR)	24/05/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	269	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2016-000897-39-DE (EUCTR)	10/05/2017	27/10/2016	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
142	EUCTR2014-005368-13-IT (EUCTR)	10/05/2017	16/02/2018	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ARCHIGEN BIOTECH LIMITED	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
143	EUCTR2016-002337-30-CZ (EUCTR)	03/05/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
144	EUCTR2016-000569-21-DE (EUCTR)	02/05/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
145	EUCTR2016-000570-37-DE (EUCTR)	19/04/2017	24/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2016-000568-41-DE (EUCTR)	19/04/2017	24/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
147	EUCTR2016-002126-36-DE (EUCTR)	18/04/2017	23/11/2016	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom
148	EUCTR2016-002337-30-BG (EUCTR)	11/04/2017	30/01/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
149	EUCTR2016-002337-30-SK (EUCTR)	10/04/2017	08/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	,NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
150	EUCTR2016-000897-39-BE (EUCTR)	03/04/2017	02/02/2017	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2016-002862-30-PL (EUCTR)	28/03/2017	03/04/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
152	EUCTR2016-002337-30-ES (EUCTR)	27/03/2017	10/03/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
153	EUCTR2011-004720-35-NL (EUCTR)	22/03/2017	22/02/2017	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE	The Karolinska Institute, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Iceland;Netherlands;Sweden
154	EUCTR2016-002862-30-CZ (EUCTR)	22/03/2017	14/12/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
155	EUCTR2016-000568-41-BG (EUCTR)	21/03/2017	24/01/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2016-000570-37-BG (EUCTR)	21/03/2017	13/02/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
157	EUCTR2016-002337-30-HU (EUCTR)	16/03/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
158	EUCTR2016-002862-30-DE (EUCTR)	15/03/2017	26/01/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
159	EUCTR2016-002126-36-AT (EUCTR)	01/03/2017	11/11/2016	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany
160	NCT03025308 (ClinicalTrials.gov)	February 28, 2017	17/1/2017	Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis	RheumatoId Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib	Gilead Sciences	Galapagos NV	Active, not recruiting	18 Years	N/A	All	2731	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2016-002862-30-BG (EUCTR)	16/02/2017	10/01/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
162	EUCTR2016-002862-30-SK (EUCTR)	16/02/2017	14/12/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
163	EUCTR2016-000569-21-PL (EUCTR)	15/02/2017	14/02/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
164	EUCTR2016-000570-37-PL (EUCTR)	15/02/2017	13/02/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
165	EUCTR2016-000568-41-PL (EUCTR)	15/02/2017	14/02/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	EUCTR2016-002862-30-HU (EUCTR)	31/01/2017	23/11/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
167	EUCTR2016-000569-21-BE (EUCTR)	30/01/2017	28/10/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	423	Phase 3	Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary
168	EUCTR2016-000570-37-BE (EUCTR)	30/01/2017	17/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
169	EUCTR2016-000568-41-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
170	EUCTR2016-000570-37-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	EUCTR2016-000569-21-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of
172	EUCTR2016-000897-39-HU (EUCTR)	09/01/2017	19/10/2016	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
173	EUCTR2016-000568-41-CZ (EUCTR)	05/01/2017	21/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
174	EUCTR2016-001532-35-BG (EUCTR)	05/01/2017	14/11/2016	A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	Moderate to Severe Rheumatoid Arthritis. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: LNP1955	Lupin Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Poland;Bulgaria
175	EUCTR2016-000570-37-CZ (EUCTR)	05/01/2017	22/11/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2016-000568-41-BE (EUCTR)	04/01/2017	17/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
177	NCT02965599 (ClinicalTrials.gov)	December 27, 2016	14/11/2016	Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis	A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: GSK3117391;Drug: Placebo	GlaxoSmithKline	NULL	Terminated	18 Years	N/A	All	3	Phase 2	Poland;Romania;Mexico
178	EUCTR2016-000569-21-GB (EUCTR)	23/12/2016	01/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
179	EUCTR2016-000568-41-GB (EUCTR)	23/12/2016	13/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
180	NCT03001219 (ClinicalTrials.gov)	December 22, 2016	20/12/2016	A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors	Rheumatoid Arthritis	Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	109	Phase 2	United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	NCT02969044 (ClinicalTrials.gov)	December 20, 2016	17/11/2016	Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate	A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate	Rheumatoid Arthritis	Drug: Placebo;Drug: PF-06651600	Pfizer	NULL	Completed	18 Years	75 Years	All	70	Phase 2	United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia
182	EUCTR2014-004704-29-DE (EUCTR)	19/12/2016	23/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
183	EUCTR2014-004704-29-CZ (EUCTR)	15/12/2016	02/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
184	NCT02862574 (ClinicalTrials.gov)	December 15, 2016	8/8/2016	Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor	Gilead Sciences	NULL	Terminated	18 Years	80 Years	All	15	Phase 2	United States;Australia;Hungary;Taiwan
185	EUCTR2016-000569-21-HU (EUCTR)	12/12/2016	07/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2016-000570-37-HU (EUCTR)	02/12/2016	19/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
187	EUCTR2016-000568-41-HU (EUCTR)	02/12/2016	19/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
188	NCT03016260 (ClinicalTrials.gov)	December 2016	4/1/2017	RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis	Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.	RheumatoId Arthritis	Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar	TcLand Expression S.A.	European Commission	Terminated	18 Years	N/A	All	250		Czechia;France;Israel;Netherlands;Turkey;Czech Republic
189	EUCTR2014-004704-29-BG (EUCTR)	29/11/2016	15/09/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
190	NCT02986139 (ClinicalTrials.gov)	November 29, 2016	2/11/2016	Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis	A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis	Arthritis, Rheumatoid; Arthritis, Psoriatic	Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept	Amgen	NULL	Completed	18 Years	N/A	All	111	Phase 3	United States;Puerto Rico
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2016-000570-37-SK (EUCTR)	29/11/2016	04/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
192	EUCTR2014-004704-29-PL (EUCTR)	25/11/2016	04/10/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany
193	EUCTR2014-005368-13-DE (EUCTR)	22/11/2016	04/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
194	EUCTR2016-000570-37-GB (EUCTR)	14/11/2016	17/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
195	NCT02996500 (ClinicalTrials.gov)	November 10, 2016	13/10/2016	Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis	Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib	Pfizer	NULL	Completed	18 Years	75 Years	All	269	Phase 2	United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	EUCTR2015-005800-27-PL (EUCTR)	08/11/2016	03/10/2016	Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs	A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK3117391 Product Code: GSK3117391 INN or Proposed INN: Not applicable Other descriptive name: GSK3117391	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Poland;Romania;Russian Federation
197	NCT02919761 (ClinicalTrials.gov)	November 7, 2016	26/9/2016	Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis	A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment	Arthritis, Rheumatoid	Drug: Acthar Gel;Drug: Placebo	Mallinckrodt	NULL	Completed	18 Years	N/A	All	259	Phase 4	United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
198	ChiCTR-IPR-16009029	2016-11-01	2016-08-15	Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis	Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis	Rheumatoid arthritis	RA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid;RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid;OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed;OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed;	Guangdong Provincial Hospital of Chinese Medicine	NULL	Pending	18	65	Both	RA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60;		China
199	EUCTR2016-000568-41-SK (EUCTR)	11/10/2016	04/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
200	NCT02937701 (ClinicalTrials.gov)	October 10, 2016	30/8/2016	Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: ABP 710;Biological: Infliximab	Amgen	NULL	Completed	18 Years	80 Years	All	558	Phase 3	United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	NCT03403140 (ClinicalTrials.gov)	October 6, 2016	30/11/2017	Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )	Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept	Gema Biotech S.A.	QUID Quality in Drugs and Devices Latin American Consulting SRL	Unknown status	19 Years	99 Years	All	141	Phase 3	Argentina
202	EUCTR2014-004704-29-HU (EUCTR)	05/10/2016	08/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
203	EUCTR2014-004704-29-ES (EUCTR)	03/10/2016	05/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
204	NCT02881307 (ClinicalTrials.gov)	October 2016	19/8/2016	Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet	Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet	Rheumatoid Arthritis;Overweight	Dietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendations	Dr. Veena Ranganath	NULL	Active, not recruiting	18 Years	N/A	All	40	N/A	United States
205	NCT02805010 (ClinicalTrials.gov)	October 2016	12/6/2016	Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously	A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects	Rheumatoid Arthritis (RA)	Drug: Abatacept;Other: Placebo	Jiangsu Simcere Pharmaceutical Co., Ltd.	Bristol-Myers Squibb	Active, not recruiting	18 Years	45 Years	Both	22	Phase 1	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2014-005368-13-ES (EUCTR)	23/09/2016	15/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
207	NCT02648035 (ClinicalTrials.gov)	September 22, 2016	5/1/2016	EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis	Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	200		Greece
208	EUCTR2014-005368-13-HU (EUCTR)	19/09/2016	11/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
209	NCT02884635 (ClinicalTrials.gov)	September 16, 2016	26/8/2016	A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate	Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)	Rheumatoid Arthritis	Drug: ASP1707;Drug: Placebo;Drug: Methotrexate	Astellas Pharma Inc	NULL	Completed	N/A	N/A	Female	72	Phase 2	Japan
210	EUCTR2014-005368-13-CZ (EUCTR)	13/09/2016	13/09/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	NCT02666443 (ClinicalTrials.gov)	September 2016	24/1/2016	Low Dose Dexamethasone in Supraclavicular Blocks	Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study	Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury	Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg	University of Calgary	NULL	Recruiting	18 Years	80 Years	Both	306	N/A	Canada
212	NCT02889796 (ClinicalTrials.gov)	August 30, 2016	31/8/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTX	Gilead Sciences	Galapagos NV	Completed	18 Years	N/A	All	1759	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic;France
213	ChiCTR-IIR-16008693	2016-08-20	2016-06-20	Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously	A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects	Rheumatoid Arthritis	Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo;	The First Hospital, Jilin University	NULL	Pending	18	45	Both	Abatacept Group:20;Placebo Group:2;	I (Phase 1 study)	China
214	NCT02705989 (ClinicalTrials.gov)	August 18, 2016	7/3/2016	Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects	A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects	Rheumatoid Arthritis	Drug: BMS-986195;Other: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	55 Years	All	439	Phase 1	Australia
215	NCT02886728 (ClinicalTrials.gov)	August 8, 2016	29/8/2016	Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX	Gilead Sciences	Galapagos NV	Completed	18 Years	N/A	All	1252	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2016-000393-37-BG (EUCTR)	08/08/2016	17/06/2016	A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma Sprl	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom
217	EUCTR2016-001532-35-HU (EUCTR)	08/08/2016	15/06/2016	A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	Moderate to Severe Rheumatoid Arthritis. MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: LNP1955	Lupin Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Bulgaria
218	NCT02892370 (ClinicalTrials.gov)	August 2016	2/9/2016	Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects	An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers	Rheumatoid Arthritis	Drug: SHR0302	Jiangsu HengRui Medicine Co., Ltd.	NULL	Recruiting	18 Years	45 Years	Male	14	Phase 1	China
219	JPRN-JapicCTI-163317	28/7/2016	13/07/2016	Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors	Rheumatoid Arthritis	Intervention name : BMS-986142 INN of the intervention : - Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified	Bristol-Myers Squibb K.K.	NULL	complete	18	120	BOTH	408	Phase 2	Japan, Asia except Japan, North America, South America, Europe, Oceania
220	NCT02873936 (ClinicalTrials.gov)	July 27, 2016	17/8/2016	Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs	Gilead Sciences	Galapagos NV	Completed	18 Years	N/A	All	449	Phase 3	United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	NCT02867306 (ClinicalTrials.gov)	July 25, 2016	11/8/2016	A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis	A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ASP1707;Drug: methotrexate (MTX)	Astellas Pharma Global Development, Inc.	NULL	Completed	18 Years	65 Years	All	10	Phase 1	Moldova, Republic of
222	NCT02804581 (ClinicalTrials.gov)	June 2016	15/6/2016	Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients	Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Dietary Supplement: Gum Arabic	Lamis Kaddam	University of Khartoum;Military hospital	Recruiting	20 Years	50 Years	Both	45	Phase 2	Sudan
223	NCT02804204 (ClinicalTrials.gov)	June 2016	8/6/2016	Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF	Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Anti-TNF	Hospital Universitari Vall d'Hebron Research Institute	UCB Pharma	Unknown status	18 Years	N/A	All	200		Spain
224	NCT02792699 (ClinicalTrials.gov)	May 17, 2016	25/4/2016	Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab	A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)	Amgen	NULL	Completed	18 Years	80 Years	All	311	Phase 3	United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada
225	NCT02780388 (ClinicalTrials.gov)	May 12, 2016	3/5/2016	A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis	A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis	Adult Onset Rheumatoid Arthritis	Drug: VIB4920;Other: Placebo	Viela Bio	NULL	Completed	18 Years	70 Years	All	57	Phase 1	United States;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	NCT02760316 (ClinicalTrials.gov)	May 2, 2016	25/4/2016	A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.	A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control	Rheumatoid Arthritis	Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg	AstraZeneca	NULL	Completed	18 Years	55 Years	All	64	Phase 1	Germany;United Kingdom
227	NCT02762123 (ClinicalTrials.gov)	May 2016	3/5/2016	A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates	Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects	Rheumatoid Arthritis	Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg	Bristol-Myers Squibb	NULL	Completed	18 Years	50 Years	Both	28	Phase 1	United States
228	NCT01815411 (ClinicalTrials.gov)	May 2016	14/3/2013	Effect of Andosan in Patients With Rheumatoid Arthritis	Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Dietary Supplement: Mushroom extract	Egil Johnson	ImmunoPharma AS	Completed	19 Years	75 Years	All	10	N/A	Norway
229	NCT02746380 (ClinicalTrials.gov)	April 2016	5/4/2016	A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Arthritis, Rheumatoid	Drug: LBAL;Drug: Humira ®	LG Life Sciences	Mochida Pharmaceutical Company, Ltd.	Active, not recruiting	20 Years	75 Years	All	380	Phase 3	Japan;Korea, Republic of
230	NCT02679001 (ClinicalTrials.gov)	March 24, 2016	8/2/2016	A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.	A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT	Rheumatoid Arthritis	Drug: TNF inhibitor/TCZ	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	200		Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	NCT02636829 (ClinicalTrials.gov)	March 2016	17/11/2015	Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis	Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis	Multiple Sclerosis;Rheumatoid Arthritis	Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview	Centre Hospitalier Universitaire de Nimes	NULL	Completed	18 Years	69 Years	Both	100	N/A	France
232	EUCTR2015-002634-41-DE (EUCTR)	25/02/2016	10/11/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
233	EUCTR2015-002634-41-BG (EUCTR)	24/02/2016	21/12/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
234	NCT02698657 (ClinicalTrials.gov)	February 23, 2016	10/2/2016	A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate	A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate	Rheumatoid Arthritis (RA)	Drug: ASP5094;Drug: Placebo	Astellas Pharma Global Development, Inc.	NULL	Completed	18 Years	65 Years	All	30	Phase 1	United States;Poland
235	NCT02321930 (ClinicalTrials.gov)	February 16, 2016	23/9/2014	Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients	Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: tofacitinib 5mg po bid	University of California, Los Angeles	NULL	Completed	18 Years	N/A	All	37	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	NCT03332719 (ClinicalTrials.gov)	February 2016	21/4/2016	Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis	Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Etanercept;Drug: Methotrexate	Gema Biotech S.A.	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Completed	19 Years	99 Years	All	168	Phase 3	Argentina
237	EUCTR2015-002809-12-BG (EUCTR)	27/01/2016	02/12/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
238	NCT02640612 (ClinicalTrials.gov)	January 22, 2016	18/12/2015	Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis	Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab	Arthritis, Rheumatoid	Drug: BI 695501	Boehringer Ingelheim	NULL	Completed	18 Years	80 Years	All	430	Phase 3	United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine
239	EUCTR2015-002634-41-PL (EUCTR)	20/01/2016	16/12/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of
240	EUCTR2014-000358-13-DE (EUCTR)	14/01/2016	31/07/2015	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Trade Name: Zostavax ® Product Name: Zostavax	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	EUCTR2015-002634-41-HU (EUCTR)	07/01/2016	16/10/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
242	NCT02636907 (ClinicalTrials.gov)	January 6, 2016	18/12/2015	Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe	Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe	Arthritis, Rheumatoid	Drug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringe	Boehringer Ingelheim	NULL	Completed	18 Years	80 Years	All	77	Phase 2	United States;Poland;Ukraine
243	EUCTR2014-000352-29-HR (EUCTR)	29/12/2015	01/02/2016	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
244	EUCTR2015-002809-12-ES (EUCTR)	23/12/2015	30/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
245	JPRN-jRCT2071200058	21/12/2015	25/11/2020	Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects	A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study	Rheumatoid arthritis;D001172	Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug	Yonemura Takuma	NULL	Complete	>= 20age old	< 45age old	Male	130	Phase 1	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
246	EUCTR2015-004173-32-DK (EUCTR)	18/12/2015	20/10/2015	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.	Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Department of Clinical Biochemestry, Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Denmark
247	EUCTR2015-002634-41-ES (EUCTR)	17/12/2015	30/10/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
248	NCT02837146 (ClinicalTrials.gov)	December 2015	7/7/2016	Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis	Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)	Rheumatoid Arthritis	Biological: Tocilizumab (TCZ);Drug: Methotrexate (MTX)	Maria Stoenoiu	NULL	Recruiting	18 Years	75 Years	Both	45	Phase 3	Belgium
249	EUCTR2015-002809-12-CZ (EUCTR)	27/11/2015	02/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
250	NCT02557100 (ClinicalTrials.gov)	November 19, 2015	4/9/2015	Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis	A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	80	Phase 4	United States;Canada;Mexico;Algeria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
251	NCT02512575 (ClinicalTrials.gov)	November 18, 2015	6/7/2015	A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.	A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.	Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis	Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	55 Years	Male	72	Phase 1	Germany
252	NCT03172325 (ClinicalTrials.gov)	November 18, 2015	24/5/2017	Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis	A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis	Active Rheumatoid Arthritis	Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone	Cinnagen	NULL	Completed	18 Years	75 Years	All	136	Phase 3	NULL
253	EUCTR2015-002809-12-LV (EUCTR)	17/11/2015	21/09/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
254	EUCTR2015-002809-12-HU (EUCTR)	17/11/2015	26/08/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
255	EUCTR2012-003876-38-PL (EUCTR)	10/11/2015	16/11/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
256	EUCTR2014-000352-29-BG (EUCTR)	21/10/2015	31/08/2015	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
257	EUCTR2015-001246-28-BE (EUCTR)	19/10/2015	23/07/2015	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra	Cliniques Universitaires Saint-Luc, Université catholique de Louvain	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
258	EUCTR2014-003307-30-GB (EUCTR)	16/10/2015	25/08/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 2	Czech Republic;Hungary;Slovakia;Russian Federation;United Kingdom
259	EUCTR2014-000110-61-DE (EUCTR)	15/10/2015	04/05/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
260	NCT02534311 (ClinicalTrials.gov)	October 13, 2015	25/8/2015	A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)	Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	60	Phase 4	Slovakia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	NCT02605642 (ClinicalTrials.gov)	September 10, 2015	2/9/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade	PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)	Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis	Drug: CT-P13	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	351		Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
262	NCT02717988 (ClinicalTrials.gov)	September 2015	4/3/2016	Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers	A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers	Rheumatoid Arthritis	Drug: SKI-O-703 capsule;Drug: Placebo capsule	Oscotec Inc.	PPD	Completed	18 Years	55 Years	All	48	Phase 1	United States
263	NCT02350426 (ClinicalTrials.gov)	August 12, 2015	15/12/2014	A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques	An Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques	Arthritis, Rheumatoid	Other: Gadobutrol;Other: 18F-FDG;Other: 18F-GE-180	GlaxoSmithKline	Cambridge University Hospitals NHS Foundation Trust	Terminated	30 Years	85 Years	All	10	Phase 1	United Kingdom
264	EUCTR2014-004887-39-PL (EUCTR)	08/08/2015	07/07/2015	A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd	NULL	Not Recruiting			Female: yes Male: yes			Poland
265	NCT02797769 (ClinicalTrials.gov)	August 2015	8/6/2016	A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)	Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases	Rheumatoid Arthritis	Drug: Other Biologics;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Not yet recruiting	18 Years	N/A	Both	75000	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
266	NCT02481180 (ClinicalTrials.gov)	July 31, 2015	18/6/2015	Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)	An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: T0001;Drug: Enbrel	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.	NULL	Terminated	18 Years	65 Years	All	36	Phase 1	China
267	EUCTR2012-003876-38-HU (EUCTR)	28/07/2015	22/05/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
268	EUCTR2012-003876-38-DE (EUCTR)	21/07/2015	29/04/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
269	EUCTR2014-003034-42-BG (EUCTR)	15/07/2015	11/05/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
270	EUCTR2014-003034-42-BE (EUCTR)	13/07/2015	18/05/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
271	EUCTR2014-000110-61-ES (EUCTR)	06/07/2015	01/06/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
272	NCT02518620 (ClinicalTrials.gov)	July 2015	6/8/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061	Rheumatoid Arthritis	Biological: ALX-0061	Ablynx	NULL	Completed	18 Years	74 Years	All	406	Phase 2	Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of
273	NCT02531178 (ClinicalTrials.gov)	July 2015	14/7/2015	A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257	Rheumatoid Arthritis	Biological: ABBV-257;Biological: Placebo	AbbVie	NULL	Completed	18 Years	75 Years	Both	8	Phase 1	Germany
274	NCT02514772 (ClinicalTrials.gov)	July 2015	30/7/2015	GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®	Sandoz	Hexal AG	Completed	18 Years	N/A	All	107	Phase 3	United States;Germany;Hungary;Poland
275	EUCTR2014-003034-42-DE (EUCTR)	29/06/2015	18/03/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	NCT02480153 (ClinicalTrials.gov)	June 25, 2015	19/6/2015	A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis	Biological: PF-06410293;Biological: Adalimumab	Pfizer	NULL	Completed	18 Years	N/A	All	597	Phase 3	United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic
277	EUCTR2014-003034-42-ES (EUCTR)	19/06/2015	14/04/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
278	EUCTR2014-003012-36-BG (EUCTR)	19/06/2015	12/03/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
279	EUCTR2014-003012-36-CZ (EUCTR)	10/06/2015	05/01/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
280	EUCTR2014-000358-13-HR (EUCTR)	08/06/2015	10/11/2015	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1080	Phase 3b;Phase 4	United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
281	EUCTR2014-001471-31-DE (EUCTR)	02/06/2015	04/02/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
282	EUCTR2015-000538-31-DE (EUCTR)	01/06/2015	07/04/2015	Application into the joint of opioids in chronic arthritis of the knee joint	NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint	chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Morphine Hexal INN or Proposed INN: Morphinsulfat Other descriptive name: MORPHINE SULFATE Trade Name: Triam 40 mg Lichtenstein INN or Proposed INN: TRIAMCINOLONACETONID Other descriptive name: TRIAMCINOLONACETONID EP	Charité University medicine Berlin	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Germany
283	EUCTR2014-003012-36-ES (EUCTR)	27/05/2015	02/02/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
284	EUCTR2014-003012-36-DE (EUCTR)	21/05/2015	29/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
285	EUCTR2014-000110-61-CZ (EUCTR)	11/05/2015	04/05/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
286	EUCTR2014-003034-42-HU (EUCTR)	08/05/2015	03/03/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
287	EUCTR2013-004569-16-DE (EUCTR)	07/05/2015	26/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy
288	EUCTR2014-005418-45-SE (EUCTR)	04/05/2015	18/03/2015	Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)	Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE	Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE	Christine Bengtsson	Solveig Wållberg-Jonsson	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
289	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
290	NCT02566967 (ClinicalTrials.gov)	May 2015	1/10/2015	An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective	An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target	Rheumatoid Arthritis	Drug: tofacitinib	Norman B. Gaylis, MD	NULL	Completed	18 Years	N/A	All	20	Phase 3	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	EUCTR2013-004569-16-GR (EUCTR)	30/04/2015	29/01/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
292	EUCTR2014-003307-30-HU (EUCTR)	16/04/2015	22/01/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
293	EUCTR2014-003307-30-SK (EUCTR)	16/04/2015	02/02/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BUMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
294	EUCTR2014-002541-22-DE (EUCTR)	02/04/2015	09/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira , 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
295	NCT02800811 (ClinicalTrials.gov)	April 2015	20/5/2016	Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104	Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects	Rheumatoid Arthritis;Complication of Transplant	Drug: FR104;Drug: Placebo	OSE Immunotherapeutics	NULL	Completed	18 Years	60 Years	Both	64	Phase 1	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	NCT02423538 (ClinicalTrials.gov)	April 2015	7/4/2015	First-in-Human Single Ascending Dose of SHR0302	A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers	Rheumatoid Arthritis	Drug: SHR0302;Drug: SHR0302 placebo comparator	Jiangsu HengRui Medicine Co., Ltd.	NULL	Active, not recruiting	18 Years	45 Years	Both	64	Phase 1	China
297	NCT02430909 (ClinicalTrials.gov)	April 2015	27/4/2015	Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis	A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Bimekizumab;Biological: Certolizumab Pegol;Other: Placebo	UCB Celltech	PRA Health Sciences	Completed	18 Years	70 Years	All	159	Phase 2	Czechia;Hungary;Moldova, Republic of;Poland;Russian Federation;Slovakia;United Kingdom;Czech Republic
298	NCT02378506 (ClinicalTrials.gov)	April 2015	13/2/2015	Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects	A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	188	Phase 3	Bulgaria;Croatia;Germany;Greece;Hungary;Poland;Serbia;Slovakia;South Africa;Russian Federation
299	NCT02499315 (ClinicalTrials.gov)	April 2015	10/4/2015	Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis	A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: AMG 357;Drug: Placebo	Amgen	NULL	Terminated	25 Years	70 Years	Female	32	Phase 1	United States
300	EUCTR2014-003307-30-CZ (EUCTR)	31/03/2015	03/02/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
301	EUCTR2014-003012-36-BE (EUCTR)	23/03/2015	18/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
302	EUCTR2014-001471-31-HU (EUCTR)	23/03/2015	23/01/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
303	EUCTR2013-004569-16-BG (EUCTR)	18/03/2015	05/01/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
304	EUCTR2014-002541-22-GB (EUCTR)	18/03/2015	09/01/2015	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira , 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	sanofi-aventis recherche & développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	340		United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
305	EUCTR2014-000352-29-FR (EUCTR)	16/03/2015	18/06/2015	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
306	EUCTR2013-004569-16-HR (EUCTR)	16/03/2015	29/04/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
307	EUCTR2014-003012-36-HU (EUCTR)	10/03/2015	30/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
308	EUCTR2014-001471-31-CZ (EUCTR)	04/03/2015	27/01/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
309	NCT02287922 (ClinicalTrials.gov)	March 2015	5/11/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate	Rheumatoid Arthritis	Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab	Ablynx	NULL	Completed	18 Years	74 Years	All	251	Phase 2	United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
310	EUCTR2013-004148-49-FR (EUCTR)	23/02/2015	18/06/2015	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
311	EUCTR2014-001114-26-SE (EUCTR)	18/02/2015	26/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
312	EUCTR2014-002541-22-ES (EUCTR)	16/02/2015	22/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	340	Phase 3	United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
313	EUCTR2014-001114-26-NL (EUCTR)	13/02/2015	24/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden
314	EUCTR2014-002541-22-HU (EUCTR)	11/02/2015	15/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira , 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	sanofi-aventis recherche & développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	340		United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
315	NCT02466581 (ClinicalTrials.gov)	February 3, 2015	29/5/2015	Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity	A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity	Rheumatoid Arthritis	Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra	Karolinska Institutet	NULL	Active, not recruiting	18 Years	N/A	All	25	Phase 4	Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
316	EUCTR2013-004569-16-HU (EUCTR)	03/02/2015	18/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
317	NCT02373202 (ClinicalTrials.gov)	February 2015	12/2/2015	A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)	A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	N/A	All	91	Phase 3	Japan
318	NCT02357069 (ClinicalTrials.gov)	February 2015	29/1/2015	A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Arthritis, Rheumatoid	Drug: Enbrel;Drug: LBEC0101	LG Life Sciences	Mochida Pharmaceutical Company, Ltd.	Active, not recruiting	20 Years	75 Years	Both	372	Phase 3	Japan;Korea, Republic of
319	NCT02332590 (ClinicalTrials.gov)	February 2015	5/1/2015	Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)	A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab)	Sanofi	Regeneron Pharmaceuticals	Active, not recruiting	18 Years	N/A	All	369	Phase 3	United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France
320	NCT02330445 (ClinicalTrials.gov)	February 2015	18/12/2014	6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection	Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers	Arthritis, Rheumatoid	Drug: PRTX-100	Protalex, Inc.	NULL	Completed	18 Years	N/A	All	13	Phase 1;Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
321	EUCTR2014-002541-22-CZ (EUCTR)	26/01/2015	09/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira , 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
322	EUCTR2014-000109-11-DE (EUCTR)	22/01/2015	08/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	730	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
323	EUCTR2014-000109-11-BG (EUCTR)	21/01/2015	10/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	730	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
324	NCT03719469 (ClinicalTrials.gov)	January 20, 2015	6/9/2018	Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis	Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea	Rh Disease	Dietary Supplement: Green tea group	King Saud University	NULL	Completed	18 Years	85 Years	All	150		NULL
325	EUCTR2013-004569-16-SK (EUCTR)	14/01/2015	21/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	EUCTR2011-002067-20-FR (EUCTR)	13/01/2015	23/08/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
327	EUCTR2014-000358-13-ES (EUCTR)	13/01/2015	22/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
328	EUCTR2013-005543-90-BG (EUCTR)	06/01/2015	22/10/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
329	NCT02198651 (ClinicalTrials.gov)	January 5, 2015	22/7/2014	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)	Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases	Biological: Adalimumab;Other: Placebo	AbbVie	NULL	Completed	18 Years	N/A	All	149	Phase 4	United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
330	EUCTR2014-000352-29-EE (EUCTR)	05/01/2015	07/08/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	EUCTR2014-000109-11-CZ (EUCTR)	18/12/2014	09/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
332	EUCTR2014-001114-26-GR (EUCTR)	12/12/2014	02/12/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
333	EUCTR2014-001114-26-IE (EUCTR)	11/12/2014	14/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
334	EUCTR2014-000352-29-DE (EUCTR)	11/12/2014	13/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
335	NCT02328027 (ClinicalTrials.gov)	December 11, 2014	18/12/2014	99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)	A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis	Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: 99mTc-rhAnnexin V-128	Advanced Accelerator Applications	NULL	Terminated	18 Years	N/A	All	16	Phase 1;Phase 2	Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
336	EUCTR2014-000109-11-ES (EUCTR)	09/12/2014	04/11/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
337	EUCTR2014-000352-29-HU (EUCTR)	05/12/2014	09/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
338	EUCTR2014-000358-13-CZ (EUCTR)	04/12/2014	04/08/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
339	EUCTR2014-000358-13-PL (EUCTR)	03/12/2014	24/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
340	EUCTR2013-001417-32-BG (EUCTR)	27/11/2014	16/09/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
341	EUCTR2014-001114-26-GB (EUCTR)	25/11/2014	14/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
342	EUCTR2013-002622-23-GR (EUCTR)	20/11/2014	23/10/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
343	EUCTR2013-005543-90-DE (EUCTR)	19/11/2014	16/06/2014	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: RITUXIMAB Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
344	EUCTR2014-002374-36-SE (EUCTR)	19/11/2014	27/08/2014	A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity.	A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Methotrexate Trade Name: Metoject Trade Name: Azathioprine Trade Name: Leflunomide	The Karolinska Institutet, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 4	Sweden
345	EUCTR2014-001114-26-ES (EUCTR)	17/11/2014	01/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	EUCTR2014-001114-26-FR (EUCTR)	13/11/2014	18/06/2015	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden
347	EUCTR2014-000358-13-EE (EUCTR)	13/11/2014	07/08/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
348	EUCTR2014-000358-13-GB (EUCTR)	12/11/2014	12/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
349	EUCTR2014-001114-26-DE (EUCTR)	10/11/2014	08/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
350	EUCTR2014-000358-13-RO (EUCTR)	10/11/2014	10/03/2015	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1080	Phase 3b;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
351	EUCTR2014-000352-29-LT (EUCTR)	06/11/2014	08/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
352	EUCTR2014-000358-13-BG (EUCTR)	06/11/2014	28/10/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
353	EUCTR2014-001114-26-AT (EUCTR)	05/11/2014	10/10/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
354	EUCTR2014-001114-26-HU (EUCTR)	04/11/2014	10/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
355	NCT02319642 (ClinicalTrials.gov)	November 2014	15/12/2014	An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044	A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.	Rheumatoid Arthritis	Drug: Certolizumab Pegol	UCB Pharma SA	Parexel	Completed	18 Years	N/A	All	347	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
356	NCT02293902 (ClinicalTrials.gov)	November 2014	13/11/2014	A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)	A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy	Rheumatoid Arthritis	Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	75 Years	All	243	Phase 3	Japan
357	NCT02287610 (ClinicalTrials.gov)	November 2014	6/11/2014	A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis	A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting	Rheumatoid Arthritis	Drug: RAYOS (delayed-release prednisone)	Horizon Pharma Ireland, Ltd., Dublin Ireland	NULL	Completed	18 Years	N/A	All	75	N/A	NULL
358	NCT02030028 (ClinicalTrials.gov)	November 2014	6/1/2014	ACTH Gel Therapy in Rheumatoid Arthritis	Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ACTHAR gel	Dana Ascherman	Mallinckrodt	Recruiting	18 Years	100 Years	All	20	N/A	United States
359	EUCTR2014-000352-29-GB (EUCTR)	29/10/2014	09/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
360	EUCTR2014-000352-29-CZ (EUCTR)	27/10/2014	05/08/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
361	EUCTR2014-000352-29-ES (EUCTR)	23/10/2014	29/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
362	EUCTR2013-004148-49-PL (EUCTR)	21/10/2014	27/08/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan
363	EUCTR2014-001114-26-IT (EUCTR)	20/10/2014	16/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
364	EUCTR2013-004148-49-BG (EUCTR)	20/10/2014	01/09/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia
365	EUCTR2014-000706-34-GB (EUCTR)	06/10/2014	18/07/2014	A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT	RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib citrate Product Code: CP -690,550 – 10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	United States;Hungary;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
366	EUCTR2014-000358-13-LT (EUCTR)	03/10/2014	11/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany
367	EUCTR2014-000358-13-LV (EUCTR)	26/09/2014	11/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
368	EUCTR2011-005689-39-SK (EUCTR)	24/09/2014	07/07/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 2	United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
369	EUCTR2013-004555-21-GR (EUCTR)	22/09/2014	21/03/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
370	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	EUCTR2013-005543-90-PL (EUCTR)	09/09/2014	11/07/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
372	EUCTR2012-003654-86-BG (EUCTR)	04/09/2014	21/05/2014	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2b	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
373	EUCTR2011-005689-39-NL (EUCTR)	01/09/2014	23/06/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP -690,550-10 Product Code: CP -690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of
374	NCT02222493 (ClinicalTrials.gov)	August 26, 2014	19/8/2014	A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).	A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate	Rheumatoid Arthritis	Biological: PF-06438179;Biological: Infliximab	Pfizer	NULL	Completed	18 Years	N/A	All	650	Phase 3	United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France
375	EUCTR2013-005543-90-HU (EUCTR)	26/08/2014	13/05/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2013-004148-49-HU (EUCTR)	13/08/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
377	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway
378	NCT02308163 (ClinicalTrials.gov)	August 8, 2014	2/12/2014	A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs	Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: Peficitinib;Drug: Placebo;Biological: Etanercept	Astellas Pharma Inc	NULL	Completed	20 Years	N/A	All	509	Phase 3	Japan;Korea, Republic of;Taiwan
379	EUCTR2013-002622-23-DE (EUCTR)	06/08/2014	27/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
380	NCT02211469 (ClinicalTrials.gov)	August 2014	6/8/2014	A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects	A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects	Rheumatoid Arthritis	Drug: BMS-986104;Drug: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	49 Years	Male	41	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
381	EUCTR2013-002622-23-ES (EUCTR)	29/07/2014	25/04/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500 INN or Proposed INN: Not applicable	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
382	EUCTR2013-004148-49-DE (EUCTR)	28/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany
383	NCT02305849 (ClinicalTrials.gov)	July 25, 2014	1/12/2014	A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment	Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Rheumatoid Arthritis	Drug: Peficitinib;Drug: Placebo;Drug: Methotrexate	Astellas Pharma Inc	NULL	Completed	20 Years	N/A	All	519	Phase 3	Japan
384	EUCTR2013-004148-49-LT (EUCTR)	14/07/2014	23/05/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina
385	EUCTR2013-004148-49-GB (EUCTR)	03/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	NCT02151851 (ClinicalTrials.gov)	July 2014	28/5/2014	A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis	A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel Group, Randomized 24-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol (CZP) as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate	Rheumatoid Arthritis	Biological: Certolizumab Pegol;Drug: Methotrexate;Other: Placebo	UCB Pharma SA, Belgium	Parexel	Completed	18 Years	N/A	All	430	Phase 3	China
387	NCT02011334 (ClinicalTrials.gov)	July 2014	4/12/2013	A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.	A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	285	Phase 3	Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
388	EUCTR2013-001417-32-ES (EUCTR)	30/06/2014	22/05/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
389	EUCTR2013-005013-13-PL (EUCTR)	25/06/2014	31/03/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
390	EUCTR2013-002622-23-NL (EUCTR)	24/06/2014	17/02/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500 INN or Proposed INN: Rituximab	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	EUCTR2013-004148-49-CZ (EUCTR)	20/06/2014	05/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab -Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab -EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
392	EUCTR2013-001417-32-LT (EUCTR)	19/06/2014	07/04/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
393	EUCTR2013-002622-23-HU (EUCTR)	03/06/2014	02/04/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
394	EUCTR2013-001417-32-DE (EUCTR)	02/06/2014	18/02/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
395	EUCTR2013-002790-22-HU (EUCTR)	02/06/2014	03/04/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120		United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
396	NCT02147587 (ClinicalTrials.gov)	June 2014	22/5/2014	A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate	A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment	Rheumatoid Arthritis	Drug: Tofacitinib;Drug: Placebo	Pfizer	NULL	Completed	50 Years	N/A	All	112	Phase 2	United States;United Kingdom
397	NCT02277574 (ClinicalTrials.gov)	June 2014	23/7/2014	Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis	A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: AMP -110;Other: Placebo	MedImmune LLC	Daiichi Sankyo Co., Ltd.	Completed	18 Years	75 Years	Both	29	Phase 1	United States
398	NCT02121210 (ClinicalTrials.gov)	June 2014	21/4/2014	To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)	An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: sarilumab SAR153191 (REGN88)	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	132	Phase 3	United States;Chile;Czechia;Estonia;Hungary;Poland;Russian Federation;Czech Republic
399	EUCTR2013-002790-22-EE (EUCTR)	30/05/2014	07/05/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120		United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile
400	EUCTR2011-004720-35-DK (EUCTR)	28/05/2014	24/02/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Netherlands;Norway;Iceland;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	EUCTR2013-001417-32-HU (EUCTR)	27/05/2014	17/03/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
402	EUCTR2013-003493-27-GR (EUCTR)	27/05/2014	16/04/2014	Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.	A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: QAL964 Other descriptive name: QAL964	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	42		Hungary;Greece;Ukraine;Romania;Russian Federation
403	EUCTR2012-003654-86-LV (EUCTR)	26/05/2014	24/04/2014	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone.	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2b	United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand
404	EUCTR2013-002790-22-CZ (EUCTR)	21/05/2014	08/04/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile
405	EUCTR2013-002622-23-PT (EUCTR)	09/05/2014	28/02/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;United States;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	EUCTR2013-005013-13-BG (EUCTR)	28/04/2014	23/04/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
407	EUCTR2013-005013-13-LT (EUCTR)	08/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
408	EUCTR2013-003493-27-HU (EUCTR)	08/04/2014	30/01/2014	Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.	A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: QAL964 Other descriptive name: QAL964	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42		Hungary;Ukraine;Russian Federation
409	EUCTR2013-004555-21-SK (EUCTR)	07/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
410	EUCTR2013-004555-21-AT (EUCTR)	07/04/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
411	NCT04582084 (ClinicalTrials.gov)	April 4, 2014	3/10/2020	Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis	Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study	Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis	Drug: Etanercept	AryoGen Pharmed Co.	NULL	Completed	18 Years	N/A	All	583		Iran, Islamic Republic of
412	EUCTR2013-005013-13-CZ (EUCTR)	03/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira ® Product Name: Humira ® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
413	EUCTR2013-002622-23-BE (EUCTR)	02/04/2014	26/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
414	EUCTR2013-004555-21-HU (EUCTR)	02/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany
415	EUCTR2013-004555-21-DE (EUCTR)	31/03/2014	17/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
416	EUCTR2013-002622-23-BG (EUCTR)	27/03/2014	21/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
417	EUCTR2013-004555-21-PT (EUCTR)	24/03/2014	07/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04117165
(ClinicalTrials.gov)

March 1, 2021

30/9/2019

Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis

Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid;Biological Therapy

Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care

University Hospital, Grenoble

NULL

Not yet recruiting

18 Years

70 Years

All

180

N/A

France

ChiCTR2000036094

2021-01-01

2020-08-21

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage

Rheumatoid Arthritis

Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

NULL

Pending

Both

Experimental group:60;Control group:60;

China

JPRN-jRCTs071200007

01/01/2021

20/04/2020

Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS.
If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

NCT04196868
(ClinicalTrials.gov)

December 3, 2020

5/12/2019

Methotrexate and Metformin in Rheumatoid Arthritis Patients

Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients

Arthritis, Rheumatoid

Drug: Metformin treatment;Other: Placebo;Drug: Methotrexate treatment

University Hospital, Bordeaux

Ministry for Health and Solidarity, France

Recruiting

18 Years

N/A

All

128

Phase 2

France

NCT04559412
(ClinicalTrials.gov)

December 2020

3/9/2020

Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis

Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Device: Sofusa DoseConnect;Drug: Enbrel

Sorrento Therapeutics, Inc.

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 1

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04292067
(ClinicalTrials.gov)

November 23, 2020

26/2/2020

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Spondyloarthritis;Rheumatoid Arthritis

Biological: Faecal sampling

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

400

France

JPRN-jRCTs071200054

18/11/2020

Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial

Rheumatoid arthritis

Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

EUCTR2019-000878-30-BE
(EUCTR)

18/11/2020

21/09/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan

NCT04608344
(ClinicalTrials.gov)

November 4, 2020

23/10/2020

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

Rheumatoid Arthritis

Drug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: Filgotinib

Gilead Sciences

Galapagos NV

Recruiting

18 Years

55 Years

All

Phase 1

United States

NCT04470453
(ClinicalTrials.gov)

November 2020

9/7/2020

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

Rheumatoid Arthritis

Biological: Blood sample;Diagnostic Test: CRQ

Centre Hospitalier Universitaire de Saint Etienne

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-000658-83-BG
(EUCTR)

21/10/2020

07/10/2020

A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate

Rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Poland;Ukraine;Georgia;Bulgaria

NCT04577781
(ClinicalTrials.gov)

October 12, 2020

30/9/2020

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Drug: GLPG3970;Drug: Placebo

Galapagos NV

NULL

Recruiting

18 Years

64 Years

All

Phase 2

Georgia;Poland;Ukraine

NCT04311567
(ClinicalTrials.gov)

October 7, 2020

5/3/2020

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial

Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD

Drug: Tofacitinib;Drug: Methotrexate

Vastra Gotaland Region

Göteborg University

Not yet recruiting

18 Years

80 Years

All

Phase 4

Sweden

EUCTR2019-002205-22-FR
(EUCTR)

01/10/2020

13/01/2020

Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04586933
(ClinicalTrials.gov)

October 2020

22/9/2020

Nutrition in Rheumatic Diseases

Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance

Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis

Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance

Haukeland University Hospital

GC Rieber Oils AS

Not yet recruiting

18 Years

75 Years

All

120

N/A

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04638426
(ClinicalTrials.gov)

September 10, 2020

13/11/2020

Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis

For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)

Rheumatoid Arthritis

Drug: HL237 tablet;Drug: Placebo of HL237 tablet

Hanlim Pharm. Co., Ltd.

NULL

Enrolling by invitation

19 Years

N/A

All

196

Phase 2

Korea, Republic of

EUCTR2019-000878-30-BG
(EUCTR)

04/09/2020

11/08/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

EUCTR2019-002676-14-BG
(EUCTR)

20/08/2020

27/05/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-002205-22-DE
(EUCTR)

12/08/2020

07/07/2020

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04457856
(ClinicalTrials.gov)

August 6, 2020

28/6/2020

A Study of TJ003234 in Rheumatoid Arthritis Patients

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: TJ003234 injection

I-Mab Biopharma Co. Ltd.

NULL

Recruiting

18 Years

70 Years

All

Phase 1

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04413617
(ClinicalTrials.gov)

July 29, 2020

19/5/2020

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid Arthritis

Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib

Pfizer

NULL

Recruiting

18 Years

70 Years

All

450

Phase 2

Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine

JPRN-jRCTs071190030

28/07/2020

11/10/2019

Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade.
The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

EUCTR2019-002676-14-CZ
(EUCTR)

07/07/2020

11/05/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-002676-14-HU
(EUCTR)

18/06/2020

14/04/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-002810-37-PL
(EUCTR)

16/06/2020

11/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002810-37-BG
(EUCTR)

15/06/2020

28/04/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany

NCT04584541
(ClinicalTrials.gov)

June 11, 2020

10/6/2020

SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism

Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments

Spondyloarthritis;Rheumatoid Arthritis;Covid19

Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

150

N/A

France

EUCTR2019-002676-14-SE
(EUCTR)

01/06/2020

14/04/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-001185-15-BG
(EUCTR)

29/05/2020

15/05/2020

A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect

A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002

rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden

NCT04333147
(ClinicalTrials.gov)

May 12, 2020

27/3/2020

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Otilimab (GSK3196165);Drug: csDMARD(s)

GlaxoSmithKline

Iqvia Pty Ltd

Recruiting

18 Years

N/A

All

2640

Phase 3

United States;Argentina;Canada;Czechia;Japan;Korea, Republic of;Latvia;Lithuania;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002205-22-GB
(EUCTR)

01/05/2020

07/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04350216
(ClinicalTrials.gov)

April 30, 2020

8/4/2020

Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)

Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Atherosclerosis

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Instituto de Investigación Marqués de Valdecilla

NULL

Not yet recruiting

18 Years

100 Years

All

Phase 4

NULL

EUCTR2019-002810-37-LT
(EUCTR)

17/04/2020

03/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany

NCT04268771
(ClinicalTrials.gov)

April 8, 2020

31/1/2020

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis

Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®

Dr. Reddy's Laboratories Limited

PPD

Recruiting

18 Years

N/A

All

140

Phase 3

United States

EUCTR2019-002205-22-ES
(EUCTR)

06/04/2020

23/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002205-22-PL
(EUCTR)

29/03/2020

07/02/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom

EUCTR2019-000878-30-HU
(EUCTR)

26/03/2020

28/02/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Product Name: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany

NCT04389320
(ClinicalTrials.gov)

March 15, 2020

11/5/2020

Antimalarial and Covid 19 in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Hydroxychloroquine

Assiut University

NULL

Completed

20 Years

70 Years

All

Egypt

EUCTR2019-003700-12-FR
(EUCTR)

13/03/2020

04/06/2020

Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug

rheumatoid arthritis
MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Methotrexate
Product Code: MTX
Other descriptive name: METHOTREXATE DISODIUM
Product Code: bDMARD
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: CERTOLIZUMAB PEGOL
INN or Proposed INN: GOLIMUMAB

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

EUCTR2019-002810-37-HU
(EUCTR)

09/03/2020

20/01/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR2000030400

2020-03-01

Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia

Interstitial pneumonia

Case series:Tetrandrine;

The First People's Hospital of Yancheng

NULL

Recruiting

Both

Case series:41;

China

EUCTR2019-000878-30-CZ
(EUCTR)

26/02/2020

06/01/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Product Name: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan

EUCTR2019-001185-15-NO
(EUCTR)

19/02/2020

07/11/2019

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Sweden

EUCTR2019-000878-30-LT
(EUCTR)

13/02/2020

25/11/2019

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan

EUCTR2019-000284-24-CZ
(EUCTR)

03/02/2020

17/10/2019

A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 4

United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004558-30-PT
(EUCTR)

03/02/2020

21/05/2019

A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.

Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Ledertrexato
Product Name: Metotrexato
Product Code: Metotrexato
INN or Proposed INN: metotrexato
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Metex Pen
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Phase 4

Portugal;Spain

NCT04230213
(ClinicalTrials.gov)

January 13, 2020

14/1/2020

A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis

Drug: PF-06410293;Drug: adalimumab

Pfizer

NULL

Recruiting

18 Years

70 Years

All

420

Phase 3

United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine

EUCTR2019-004179-38-SE
(EUCTR)

10/01/2020

19/11/2019

Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis

Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA

Patients with early active rheumatoid arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Västra Götalandsregionen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

145

Phase 4

Sweden

NCT04186871
(ClinicalTrials.gov)

January 7, 2020

28/11/2019

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome

Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

65 Years

All

185

Phase 2

United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom

JPRN-UMIN000042632

2020/01/01

03/12/2020

THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS

THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis

Rheumatoid arthritis

low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses.
The laser apparatuses used for therapy in this study were the following,
1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW.
2.GaAIAs diode laser (830 nm, maximum output power 300 mW).
12 patients
placebo laser and naproxen
Naproxen is given as tablet 500mg twice per day.
12 patients
naproxen
Naproxen is given as tablet 500mg twice per day.
10 patients

Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not applicable

Asia(except Japan)

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000284-24-LT
(EUCTR)

18/12/2019

07/11/2019

A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina

EUCTR2018-004287-56-FR
(EUCTR)

21/11/2019

31/01/2020

Methotrexate and Metformin in rheumatoid arthritis patients

Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2

rheumatoid arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

CHU de Bordeaux

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

128

Phase 2

France

EUCTR2019-001185-15-SE
(EUCTR)

06/11/2019

01/07/2019

A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization). The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect

rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Moldova, Republic of;Sweden

NCT03194204
(ClinicalTrials.gov)

October 1, 2019

10/6/2017

Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial

Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Doxycycline Tablets

Assiut University

NULL

Completed

18 Years

60 Years

All

160

N/A

Egypt

ChiCTR1900026257

2019-09-28

A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue

Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial

Rheumatoid arthritis (RA)

High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;

Zhejiang Provincal Hospital of TCM

NULL

Pending

Both

High-dose experimental group :30;Low-dose experimental group:30;Control group :30;

Phase 2

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03971253
(ClinicalTrials.gov)

September 2, 2019

30/5/2019

Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Drug: Peficitinib

Astellas Pharma Inc

NULL

Recruiting

N/A

All

3000

Japan

JPRN-jRCTs071190001

29/08/2019

02/04/2019

Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity

Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study

Rheumatoid arthritis

Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study.

Control group
combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

Intervention group
monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

The discontinuation criteria for the study are as follows:
1) When subjects requested to discontinue the treatment
2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events
3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study
4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits
5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above

Miyazaki Yusuke

Tanaka Yoshiya

Recruiting

>= 16age old

Not applicable

Both

150

Phase 4

Japan

JPRN-JapicCTI-194928

26/8/2019

22/08/2019

-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101

An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101

Rheumatoid Arthritis

Intervention name : methotrexate
INN of the intervention : methotrexate
Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg.
Control intervention name : methotrexate
INN of the control intervention : methotrexate
Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.

medac GmbH

NULL

complete

BOTH

100

Phase 3

Japan

NCT04068246
(ClinicalTrials.gov)

August 1, 2019

21/8/2019

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.

Rheumatoid Arthritis

Drug: Metformin;Drug: Placebo

Sadat City University

NULL

Recruiting

18 Years

N/A

All

150

Early Phase 1

Egypt

NCT04464642
(ClinicalTrials.gov)

July 10, 2019

6/7/2020

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Tofacitinib

Dr. Mohammad Mamun Khan

NULL

Active, not recruiting

18 Years

N/A

All

110

Phase 4

Bangladesh

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03912428
(ClinicalTrials.gov)

June 14, 2019

10/4/2019

Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Myositis

Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176

National Institute of Mental Health (NIMH)

NULL

Recruiting

18 Years

N/A

All

Phase 4

United States

EUCTR2018-003877-91-DE
(EUCTR)

13/06/2019

26/02/2019

B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy

Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA

Active rheumatoid arthritis with ACPA antibodies failing methotrexate
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
INN or Proposed INN: ABATACEPT

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

EUCTR2019-001185-15-DK
(EUCTR)

06/06/2019

12/04/2019

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Sweden

NCT04344405
(ClinicalTrials.gov)

June 1, 2019

9/4/2020

Vitamin D as a Key Player in Rheumatoid Arthritis

Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response

the Immunomodulatory Effect

Drug: Vitamin D;Drug: Placebo

Assiut University

NULL

Recruiting

20 Years

70 Years

All

Phase 3

Egypt

EUCTR2018-004558-30-ES
(EUCTR)

16/05/2019

11/04/2019

Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.

rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-002306-31-GB
(EUCTR)

15/05/2019

14/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)

Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom

EUCTR2018-002306-31-BE
(EUCTR)

30/04/2019

07/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom

EUCTR2018-002306-31-ES
(EUCTR)

04/04/2019

12/04/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom

NCT03700021
(ClinicalTrials.gov)

April 2019

2/10/2018

Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis

Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: Abatacept + csDMARD

New York University School of Medicine

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

United States

NCT03890302
(ClinicalTrials.gov)

March 14, 2019

25/3/2019

Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A

A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A

Rheumatoid Arthritis

Drug: FB704A;Drug: Placebo

Fountain Biopharma Inc.

Oneness Biotech Co., Ltd.

Completed

18 Years

55 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-002306-31-HU
(EUCTR)

08/03/2019

11/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom

NCT03813771
(ClinicalTrials.gov)

March 2019

12/9/2018

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.

Rheumatoid Arthritis

Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine

University of Leeds

Samsung Bioepis Co., Ltd.

Not yet recruiting

18 Years

N/A

All

106

Phase 4

United Kingdom

NCT03852355
(ClinicalTrials.gov)

February 25, 2019

22/2/2019

the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis

the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial

Rheumatoid Arthritis;Headache

Drug: Radiofrequency;Drug: Steroids

Assiut University

NULL

Completed

18 Years

60 Years

All

N/A

Egypt

EUCTR2018-000666-10-BE
(EUCTR)

19/02/2019

16/11/2018

A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom

NCT03737708
(ClinicalTrials.gov)

February 13, 2019

8/11/2018

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial

Rheumatoid Arthritis (RA)

Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept

Astellas Pharma Korea, Inc.

NULL

Completed

19 Years

75 Years

All

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000666-10-ES
(EUCTR)

23/01/2019

22/01/2019

Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom

EUCTR2018-000666-10-HU
(EUCTR)

03/01/2019

29/10/2018

Product Code: ABBV-105
Other descriptive name: ABBV-105 , A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105 , A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom

NCT03574545
(ClinicalTrials.gov)

December 19, 2018

21/6/2018

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: ianalumab

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

65 Years

All

Phase 1

Germany;Jordan

EUCTR2018-000666-10-GB
(EUCTR)

17/12/2018

24/10/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom

EUCTR2017-004226-15-DK
(EUCTR)

26/10/2018

05/01/2018

Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.

CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art

Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

King Christian 10th Hospital for Rheumatology

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03660059
(ClinicalTrials.gov)

September 27, 2018

26/8/2018

A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX

Rheumatoid Arthritis (RA)

Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)

Astellas Pharma China, Inc.

NULL

Active, not recruiting

18 Years

N/A

All

385

Phase 3

China;Korea, Republic of;Taiwan

NCT03691909
(ClinicalTrials.gov)

September 25, 2018

27/9/2018

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis

A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: HB-adMSCs

Hope Biosciences

NULL

Completed

18 Years

65 Years

All

Phase 1;Phase 2

United States

NCT03699293
(ClinicalTrials.gov)

September 22, 2018

21/9/2018

NSAIDs vs. Coxibs in the Presence of Aspirin

NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease

Rheumatoid Arthritis;Cardiovascular Diseases

Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet

Inova Health Care Services

NULL

Unknown status

18 Years

75 Years

All

Phase 4

United States

NCT04056039
(ClinicalTrials.gov)

August 14, 2018

21/6/2019

Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.

Cardiovascular Diseases;Arthritis, Rheumatoid

Drug: Atorvastatin;Drug: Colchicine

Hospital Central Dr. Ignacio Morones Prieto

NULL

Completed

18 Years

N/A

All

Phase 2

Mexico

EUCTR2018-002368-18-ES
(EUCTR)

25/07/2018

Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load

1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH).
MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Fendrix suspension for injection
Product Name: Fendrix
Product Code: Fendrix
INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Other descriptive name: HEPATITIS B VACCINE (RDNA)
Trade Name: HBVAXPRO 5 micrograms/0.5 ml
Product Name: HBVAXPRO ® 40 micrograms
Product Code: HBVAXPRO ® 40 micrograms
INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)

FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

740

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03445871
(ClinicalTrials.gov)

July 2, 2018

20/2/2018

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Rheumatoid Arthritis

Biological: Blood sample;Diagnostic Test: CRQ

Centre Hospitalier Universitaire de Saint Etienne

NULL

Completed

18 Years

N/A

All

Phase 4

France

EUCTR2016-002344-16-GB
(EUCTR)

28/06/2018

29/11/2017

Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.

Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University of Leeds

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

106

Phase 4

United Kingdom

NCT03084419
(ClinicalTrials.gov)

June 26, 2018

7/3/2017

APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial

Rheumatoid Arthritis;Interstitial Lung Disease

Drug: Abatacept

Cambridge University Hospitals NHS Foundation Trust

Bristol-Myers Squibb

Recruiting

18 Years

N/A

All

Phase 2

United Kingdom

NCT03535402
(ClinicalTrials.gov)

June 1, 2018

9/5/2018

Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.

Rheumatoid Arthritis

Drug: Sarilumab

Gaylis, Norman B., M.D.

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

United States

EUCTR2017-001944-36-ES
(EUCTR)

21/05/2018

10/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG592
INN or Proposed INN: AMG 592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

137

Phase 1;Phase 2

United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03492658
(ClinicalTrials.gov)

May 17, 2018

3/4/2018

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).

Rheumatoid Arthritis;Rheumatic Diseases

Drug: Abatacept;Drug: Methotrexate

Leiden University Medical Center

NULL

Recruiting

18 Years

N/A

All

Phase 4

Netherlands

EUCTR2016-002569-68-GB
(EUCTR)

04/05/2018

18/05/2018

Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease

Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL

Rheumatoid-associated Interstitial Lung Disease (RA-ILD)
MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

JPRN-UMIN000030584

2018/04/18

27/12/2017

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Rheumatoid Arthritis

Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1).
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated.
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage

Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine

Eisai Co., Ltd.

Complete: follow-up continuing

18years-old

Not applicable

Male and Female

300

Not selected

Japan,Asia(except Japan)

JPRN-jRCT1031180088

18/04/2018

18/01/2019

MIRACLE Study

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Rheumatoid Arthritis
Rheumatoid Arthritis

Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period).
To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle.
If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1).
If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3).
The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week.
Subjects in whom MTX at a dosage >=

Kaneko Yuko

Eisai Co., Ltd.

Not Recruiting

>= 18age old

Not applicable

Both

300

Phase 4

South Korea;Taiwan;Japan

NCT03505008
(ClinicalTrials.gov)

April 18, 2018

16/4/2018

Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Adalimumab

Keio University

Eisai Co., Ltd.

Active, not recruiting

18 Years

N/A

All

300

Phase 4

Japan;Korea, Republic of;Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCTs071180018

13/04/2018

15/02/2019

Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.

Rheumatoid arthritis

Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.

Kawakami Atsushi

Nakagaki Hisashi;Daiichi Sankyo co.,LTD.

Not Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

JPRN-UMIN000030575

2018/03/31

26/12/2017

Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.

Rheumatoid arthritis

Daiichi Sankyo Company, Limited

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not applicable

Japan

EUCTR2017-001944-36-BG
(EUCTR)

13/03/2018

24/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG592
INN or Proposed INN: N/A
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

153

Phase 1;Phase 2

United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand

ChiCTR1800014584

2018-03-01

2018-01-22

Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.

Knee osteoartritis;Rheumatoid arthritis

Experimental group:Asprin;Controlled group:Rivaroxaban;

Department of Orthopaedics, West China Hospital, Sichuan University

NULL

Pending

100

Both

Experimental group:90;Controlled group:30;

China

100

EUCTR2017-004348-39-FR
(EUCTR)

15/02/2018

16/01/2018

Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU

rheumatoid arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: methotrexate
Product Code: 1

CHU Saint-Etienne

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2016-003630-25-NL
(EUCTR)

08/02/2018

06/09/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan

102

EUCTR2017-002878-38-NL
(EUCTR)

07/02/2018

12/09/2017

Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis

Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA

Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Orencia 125 mg
INN or Proposed INN: ABATACEPT

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

103

NCT04022525
(ClinicalTrials.gov)

February 1, 2018

15/7/2019

Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Rheumatoid Arthritis

Drug: Leflunomide 20Mg Tab

Assiut University

NULL

Completed

18 Years

N/A

All

Egypt

104

NCT01694693
(ClinicalTrials.gov)

January 31, 2018

24/9/2012

Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Rheumatoid Arthritis

Drug: Orencia

Bristol-Myers Squibb

NULL

Withdrawn

18 Years

N/A

All

N/A

NULL

105

NCT03368235
(ClinicalTrials.gov)

January 18, 2018

3/11/2017

Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AZD9567;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

80 Years

All

Phase 2

Netherlands;Sweden;Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

NCT04312815
(ClinicalTrials.gov)

December 28, 2017

16/3/2020

A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis(RA)

Drug: SM03;Drug: Placebo;Drug: MTX

SinoMab Pty Ltd

NULL

Recruiting

18 Years

70 Years

All

510

Phase 3

China

107

EUCTR2014-000555-93-ES
(EUCTR)

18/12/2017

10/10/2017

Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia

Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Universitätsklinikum Erlangen

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Czech Republic;Brazil;Spain;Germany

108

EUCTR2017-001944-36-PL
(EUCTR)

23/11/2017

11/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG 592
INN or Proposed INN: AMG592
Other descriptive name: AMG592

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

153

Phase 1;Phase 2

United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom

109

EUCTR2017-000838-64-NL
(EUCTR)

10/11/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Code: AZD9567 monohydrate
INN or Proposed INN: AZD9567
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolone

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

110

NCT03329885
(ClinicalTrials.gov)

November 2, 2017

31/10/2017

A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis

Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis

Drug: BMS-986251;Other: Placebo

Bristol-Myers Squibb

NULL

Terminated

18 Years

70 Years

All

Phase 1;Phase 2

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

JPRN-UMIN000029759

2017/11/01

01/11/2017

Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial

Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis

Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

112

EUCTR2016-002126-36-IT
(EUCTR)

26/10/2017

31/01/2018

A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: RO7123520
Product Code: RO7123520 /F03-01

F. Hoffmann - Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

113

EUCTR2017-000149-30-GB
(EUCTR)

25/10/2017

05/09/2017

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1

Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

University Hospitals of Leicester NHS Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Canada;Australia;United Kingdom

114

JPRN-UMIN000029003

2017/10/01

05/09/2017

Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial

Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis

Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after total knee arthroplasty

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

115

NCT03257852
(ClinicalTrials.gov)

September 29, 2017

20/8/2017

A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis (RA)

Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

NCT03312465
(ClinicalTrials.gov)

September 28, 2017

12/10/2017

Anatomical Shoulder Domelock System Study

Anatomical Shoulder™ Domelock System A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study

Advanced Wear and Tear of the Shoulder Joint;Avascular Necrosis;Conditions Consequent to Earlier Operations;Omarthrosis;Rheumatoid Arthritis;Revision of Shoulder Prosthesis

Device: AS Domelock System

Zimmer Biomet

NULL

Recruiting

18 Years

80 Years

All

123

Belgium;Germany;Switzerland;United Kingdom

117

EUCTR2017-000838-64-SE
(EUCTR)

11/09/2017

19/05/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Name: AZD9567
Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

118

NCT04177173
(ClinicalTrials.gov)

September 1, 2017

7/4/2019

Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis

Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.

Arthritis, Rheumatoid

Drug: Simvastatin 20 mg;Drug: Methotrexate 10 mg

King Edward Medical University

NULL

Completed

18 Years

N/A

All

100

Phase 4

Pakistan

119

NCT03254966
(ClinicalTrials.gov)

September 2017

15/8/2017

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: SHR0302;Drug: Placebo

Jiangsu HengRui Medicine Co., Ltd.

NULL

Not yet recruiting

18 Years

70 Years

All

170

Phase 2

China

120

EUCTR2017-000838-64-DK
(EUCTR)

25/08/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2017-000947-41-FR
(EUCTR)

18/08/2017

21/06/2017

ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.

ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR

Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie
Trade Name: RoActemra 162 mg solution injectable en seringue préremplie

Groupement des Hôpitaux de l’Institut Catholique de Lille

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

122

EUCTR2016-003630-25-DE
(EUCTR)

14/08/2017

13/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

123

NCT03156023
(ClinicalTrials.gov)

August 14, 2017

15/5/2017

Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 570;Drug: Placebo

Amgen

NULL

Completed

18 Years

75 Years

All

Phase 1

United States;Germany

124

EUCTR2013-005543-90-EE
(EUCTR)

07/08/2017

02/06/2017

This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 Biosimilar to Rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

125

NCT03155347
(ClinicalTrials.gov)

August 2, 2017

15/5/2017

An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

70 Years

All

340

Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2016-003630-25-BE
(EUCTR)

01/08/2017

12/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

127

EUCTR2016-002126-36-ES
(EUCTR)

31/07/2017

02/06/2017

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

128

EUCTR2016-003630-25-GB
(EUCTR)

19/07/2017

15/08/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

129

EUCTR2016-000569-21-NL
(EUCTR)

18/07/2017

29/06/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

130

EUCTR2016-000568-41-NL
(EUCTR)

18/07/2017

29/06/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

JPRN-jRCT2071200057

08/07/2017

25/11/2020

Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study

A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study

Rheumatoid arthritis;D001172

Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Yazawa Rie

NULL

Complete

>= 20age old

< 45age old

Male

130

Phase 1

Japan

132

NCT03394131
(ClinicalTrials.gov)

July 1, 2017

25/12/2017

?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

Treatment of Carpal Tunnel in Rheumatoid Arthritis

Treatment Resistant Carpal Tunnel in RA Patients

Drug: Hylase;Drug: Insulin;Other: saline

Assiut University

NULL

Unknown status

20 Years

80 Years

All

N/A

Egypt

133

NCT03278470
(ClinicalTrials.gov)

June 26, 2017

7/9/2017

A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject

Rheumatoid Arthritis

Drug: HL237;Drug: Placebo Oral Tablet

Hanlim Pharm. Co., Ltd.

NULL

Completed

20 Years

45 Years

Male

Phase 1

Korea, Republic of

134

EUCTR2016-003630-25-SK
(EUCTR)

15/06/2017

04/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan

135

EUCTR2016-003630-25-ES
(EUCTR)

09/06/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2016-000569-21-FR
(EUCTR)

08/06/2017

04/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

137

EUCTR2016-003630-25-PL
(EUCTR)

07/06/2017

24/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

138

EUCTR2016-002337-30-HR
(EUCTR)

05/06/2017

12/09/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina

139

EUCTR2016-003630-25-HU
(EUCTR)

29/05/2017

12/04/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong

140

EUCTR2016-002337-30-DE
(EUCTR)

24/05/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

269

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2016-000897-39-DE
(EUCTR)

10/05/2017

27/10/2016

An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany

142

EUCTR2014-005368-13-IT
(EUCTR)

10/05/2017

16/02/2018

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ARCHIGEN BIOTECH LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

143

EUCTR2016-002337-30-CZ
(EUCTR)

03/05/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

144

EUCTR2016-000569-21-DE
(EUCTR)

02/05/2017

04/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

145

EUCTR2016-000570-37-DE
(EUCTR)

19/04/2017

24/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2016-000568-41-DE
(EUCTR)

19/04/2017

24/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

147

EUCTR2016-002126-36-DE
(EUCTR)

18/04/2017

23/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom

148

EUCTR2016-002337-30-BG
(EUCTR)

11/04/2017

30/01/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

149

EUCTR2016-002337-30-SK
(EUCTR)

10/04/2017

08/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

,NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

150

EUCTR2016-000897-39-BE
(EUCTR)

03/04/2017

02/02/2017

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2016-002862-30-PL
(EUCTR)

28/03/2017

03/04/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

152

EUCTR2016-002337-30-ES
(EUCTR)

27/03/2017

10/03/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

153

EUCTR2011-004720-35-NL
(EUCTR)

22/03/2017

22/02/2017

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

Rheumatoid arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE

The Karolinska Institute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Iceland;Netherlands;Sweden

154

EUCTR2016-002862-30-CZ
(EUCTR)

22/03/2017

14/12/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

155

EUCTR2016-000568-41-BG
(EUCTR)

21/03/2017

24/01/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2016-000570-37-BG
(EUCTR)

21/03/2017

13/02/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

157

EUCTR2016-002337-30-HU
(EUCTR)

16/03/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

158

EUCTR2016-002862-30-DE
(EUCTR)

15/03/2017

26/01/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

159

EUCTR2016-002126-36-AT
(EUCTR)

01/03/2017

11/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany

160

NCT03025308
(ClinicalTrials.gov)

February 28, 2017

17/1/2017

Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

RheumatoId Arthritis

Drug: Filgotinib;Drug: Placebo to match filgotinib

Gilead Sciences

Galapagos NV

Active, not recruiting

18 Years

N/A

All

2731

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2016-002862-30-BG
(EUCTR)

16/02/2017

10/01/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

162

EUCTR2016-002862-30-SK
(EUCTR)

16/02/2017

14/12/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

163

EUCTR2016-000569-21-PL
(EUCTR)

15/02/2017

14/02/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

164

EUCTR2016-000570-37-PL
(EUCTR)

15/02/2017

13/02/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

165

EUCTR2016-000568-41-PL
(EUCTR)

15/02/2017

14/02/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2016-002862-30-HU
(EUCTR)

31/01/2017

23/11/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

167

EUCTR2016-000569-21-BE
(EUCTR)

30/01/2017

28/10/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary

168

EUCTR2016-000570-37-BE
(EUCTR)

30/01/2017

17/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

169

EUCTR2016-000568-41-ES
(EUCTR)

13/01/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

170

EUCTR2016-000570-37-ES
(EUCTR)

13/01/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

EUCTR2016-000569-21-ES
(EUCTR)

13/01/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of

172

EUCTR2016-000897-39-HU
(EUCTR)

09/01/2017

19/10/2016

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany

173

EUCTR2016-000568-41-CZ
(EUCTR)

05/01/2017

21/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

174

EUCTR2016-001532-35-BG
(EUCTR)

05/01/2017

14/11/2016

A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

Moderate to Severe Rheumatoid Arthritis.
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: LNP1955

Lupin Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Bulgaria

175

EUCTR2016-000570-37-CZ
(EUCTR)

05/01/2017

22/11/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2016-000568-41-BE
(EUCTR)

04/01/2017

17/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

177

NCT02965599
(ClinicalTrials.gov)

December 27, 2016

14/11/2016

Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis

A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: GSK3117391;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

Phase 2

Poland;Romania;Mexico

178

EUCTR2016-000569-21-GB
(EUCTR)

23/12/2016

01/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

179

EUCTR2016-000568-41-GB
(EUCTR)

23/12/2016

13/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

180

NCT03001219
(ClinicalTrials.gov)

December 22, 2016

20/12/2016

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors

Rheumatoid Arthritis

Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

109

Phase 2

United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

NCT02969044
(ClinicalTrials.gov)

December 20, 2016

17/11/2016

Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: PF-06651600

Pfizer

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia

182

EUCTR2014-004704-29-DE
(EUCTR)

19/12/2016

23/08/2016

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

183

EUCTR2014-004704-29-CZ
(EUCTR)

15/12/2016

02/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

184

NCT02862574
(ClinicalTrials.gov)

December 15, 2016

8/8/2016

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor

Gilead Sciences

NULL

Terminated

18 Years

80 Years

All

Phase 2

United States;Australia;Hungary;Taiwan

185

EUCTR2016-000569-21-HU
(EUCTR)

12/12/2016

07/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2016-000570-37-HU
(EUCTR)

02/12/2016

19/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

187

EUCTR2016-000568-41-HU
(EUCTR)

02/12/2016

19/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

188

NCT03016260
(ClinicalTrials.gov)

December 2016

4/1/2017

RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis

Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.

RheumatoId Arthritis

Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar

TcLand Expression S.A.

European Commission

Terminated

18 Years

N/A

All

250

Czechia;France;Israel;Netherlands;Turkey;Czech Republic

189

EUCTR2014-004704-29-BG
(EUCTR)

29/11/2016

15/09/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

190

NCT02986139
(ClinicalTrials.gov)

November 29, 2016

2/11/2016

Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis

A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis

Arthritis, Rheumatoid; Arthritis, Psoriatic

Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept

Amgen

NULL

Completed

18 Years

N/A

All

111

Phase 3

United States;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

EUCTR2016-000570-37-SK
(EUCTR)

29/11/2016

04/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

192

EUCTR2014-004704-29-PL
(EUCTR)

25/11/2016

04/10/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany

193

EUCTR2014-005368-13-DE
(EUCTR)

22/11/2016

04/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Product Name: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

194

EUCTR2016-000570-37-GB
(EUCTR)

14/11/2016

17/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

195

NCT02996500
(ClinicalTrials.gov)

November 10, 2016

13/10/2016

Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib

Pfizer

NULL

Completed

18 Years

75 Years

All

269

Phase 2

United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

EUCTR2015-005800-27-PL
(EUCTR)

08/11/2016

03/10/2016

Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs

A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK3117391
Product Code: GSK3117391
INN or Proposed INN: Not applicable
Other descriptive name: GSK3117391

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Romania;Russian Federation

197

NCT02919761
(ClinicalTrials.gov)

November 7, 2016

26/9/2016

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment

Arthritis, Rheumatoid

Drug: Acthar Gel;Drug: Placebo

Mallinckrodt

NULL

Completed

18 Years

N/A

All

259

Phase 4

United States;Argentina;Mexico;Peru;Puerto Rico;Colombia

198

ChiCTR-IPR-16009029

2016-11-01

2016-08-15

Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis

Rheumatoid arthritis

RA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid;RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid;OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed;OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Pending

Both

RA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60;

China

199

EUCTR2016-000568-41-SK
(EUCTR)

11/10/2016

04/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

200

NCT02937701
(ClinicalTrials.gov)

October 10, 2016

30/8/2016

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: ABP 710;Biological: Infliximab

Amgen

NULL

Completed

18 Years

80 Years

All

558

Phase 3

United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

NCT03403140
(ClinicalTrials.gov)

October 6, 2016

30/11/2017

Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )

Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept

Gema Biotech S.A.

QUID Quality in Drugs and Devices Latin American Consulting SRL

Unknown status

19 Years

99 Years

All

141

Phase 3

Argentina

202

EUCTR2014-004704-29-HU
(EUCTR)

05/10/2016

08/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

203

EUCTR2014-004704-29-ES
(EUCTR)

03/10/2016

05/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

204

NCT02881307
(ClinicalTrials.gov)

October 2016

19/8/2016

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Rheumatoid Arthritis;Overweight

Dietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendations

Dr. Veena Ranganath

NULL

Active, not recruiting

18 Years

N/A

All

N/A

United States

205

NCT02805010
(ClinicalTrials.gov)

October 2016

12/6/2016

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects

Rheumatoid Arthritis (RA)

Drug: Abatacept;Other: Placebo

Jiangsu Simcere Pharmaceutical Co., Ltd.

Bristol-Myers Squibb

Active, not recruiting

18 Years

45 Years

Both

Phase 1

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

EUCTR2014-005368-13-ES
(EUCTR)

23/09/2016

15/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

207

NCT02648035
(ClinicalTrials.gov)

September 22, 2016

5/1/2016

EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.

Rheumatoid Arthritis

Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

200

Greece

208

EUCTR2014-005368-13-HU
(EUCTR)

19/09/2016

11/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy

209

NCT02884635
(ClinicalTrials.gov)

September 16, 2016

26/8/2016

A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate

Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Rheumatoid Arthritis

Drug: ASP1707;Drug: Placebo;Drug: Methotrexate

Astellas Pharma Inc

NULL

Completed

N/A

Female

Phase 2

Japan

210

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

NCT02666443
(ClinicalTrials.gov)

September 2016

24/1/2016

Low Dose Dexamethasone in Supraclavicular Blocks

Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study

Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury

Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg

University of Calgary

NULL

Recruiting

18 Years

80 Years

Both

306

N/A

Canada

212

NCT02889796
(ClinicalTrials.gov)

August 30, 2016

31/8/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: Adalimumab;Drug: Placebo to match adalimumab;Drug: MTX

Gilead Sciences

Galapagos NV

Completed

18 Years

N/A

All

1759

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic;France

213

ChiCTR-IIR-16008693

2016-08-20

2016-06-20

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects

Rheumatoid Arthritis

Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo;

The First Hospital, Jilin University

NULL

Pending

Both

Abatacept Group:20;Placebo Group:2;

I (Phase 1 study)

China

214

NCT02705989
(ClinicalTrials.gov)

August 18, 2016

7/3/2016

Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects

Rheumatoid Arthritis

Drug: BMS-986195;Other: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

All

439

Phase 1

Australia

215

NCT02886728
(ClinicalTrials.gov)

August 8, 2016

29/8/2016

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

Rheumatoid Arthritis

Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX

Gilead Sciences

Galapagos NV

Completed

18 Years

N/A

All

1252

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2016-000393-37-BG
(EUCTR)

08/08/2016

17/06/2016

A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.

A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma Sprl

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom

217

EUCTR2016-001532-35-HU
(EUCTR)

08/08/2016

15/06/2016

A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

Moderate to Severe Rheumatoid Arthritis.
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: LNP1955

Lupin Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Bulgaria

218

NCT02892370
(ClinicalTrials.gov)

August 2016

2/9/2016

Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

Rheumatoid Arthritis

Drug: SHR0302

Jiangsu HengRui Medicine Co., Ltd.

NULL

Recruiting

18 Years

45 Years

Male

Phase 1

China

219

JPRN-JapicCTI-163317

28/7/2016

13/07/2016

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

Rheumatoid Arthritis

Intervention name : BMS-986142
INN of the intervention : -
Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified

Bristol-Myers Squibb K.K.

NULL

complete

120

BOTH

408

Phase 2

Japan, Asia except Japan, North America, South America, Europe, Oceania

220

NCT02873936
(ClinicalTrials.gov)

July 27, 2016

17/8/2016

Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Rheumatoid Arthritis

Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs

Gilead Sciences

Galapagos NV

Completed

18 Years

N/A

All

449

Phase 3

United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

NCT02867306
(ClinicalTrials.gov)

July 25, 2016

11/8/2016

A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ASP1707;Drug: methotrexate (MTX)

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

Moldova, Republic of

222

NCT02804581
(ClinicalTrials.gov)

June 2016

15/6/2016

Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Dietary Supplement: Gum Arabic

Lamis Kaddam

University of Khartoum;Military hospital

Recruiting

20 Years

50 Years

Both

Phase 2

Sudan

223

NCT02804204
(ClinicalTrials.gov)

June 2016

8/6/2016

Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Anti-TNF

Hospital Universitari Vall d'Hebron Research Institute

UCB Pharma

Unknown status

18 Years

N/A

All

200

Spain

224

NCT02792699
(ClinicalTrials.gov)

May 17, 2016

25/4/2016

Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)

Amgen

NULL

Completed

18 Years

80 Years

All

311

Phase 3

United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada

225

NCT02780388
(ClinicalTrials.gov)

May 12, 2016

3/5/2016

A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis

Adult Onset Rheumatoid Arthritis

Drug: VIB4920;Other: Placebo

Viela Bio

NULL

Completed

18 Years

70 Years

All

Phase 1

United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

NCT02760316
(ClinicalTrials.gov)

May 2, 2016

25/4/2016

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.

A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control

Rheumatoid Arthritis

Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg

AstraZeneca

NULL

Completed

18 Years

55 Years

All

Phase 1

Germany;United Kingdom

227

NCT02762123
(ClinicalTrials.gov)

May 2016

3/5/2016

A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects

Rheumatoid Arthritis

Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg

Bristol-Myers Squibb

NULL

Completed

18 Years

50 Years

Both

Phase 1

United States

228

NCT01815411
(ClinicalTrials.gov)

May 2016

14/3/2013

Effect of Andosan in Patients With Rheumatoid Arthritis

Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Dietary Supplement: Mushroom extract

Egil Johnson

ImmunoPharma AS

Completed

19 Years

75 Years

All

N/A

Norway

229

NCT02746380
(ClinicalTrials.gov)

April 2016

5/4/2016

A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Arthritis, Rheumatoid

Drug: LBAL;Drug: Humira ®

LG Life Sciences

Mochida Pharmaceutical Company, Ltd.

Active, not recruiting

20 Years

75 Years

All

380

Phase 3

Japan;Korea, Republic of

230

NCT02679001
(ClinicalTrials.gov)

March 24, 2016

8/2/2016

A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

Rheumatoid Arthritis

Drug: TNF inhibitor/TCZ

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

200

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

NCT02636829
(ClinicalTrials.gov)

March 2016

17/11/2015

Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis

Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis

Multiple Sclerosis;Rheumatoid Arthritis

Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview

Centre Hospitalier Universitaire de Nimes

NULL

Completed

18 Years

69 Years

Both

100

N/A

France

232

EUCTR2015-002634-41-DE
(EUCTR)

25/02/2016

10/11/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

233

EUCTR2015-002634-41-BG
(EUCTR)

24/02/2016

21/12/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

234

NCT02698657
(ClinicalTrials.gov)

February 23, 2016

10/2/2016

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis (RA)

Drug: ASP5094;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

United States;Poland

235

NCT02321930
(ClinicalTrials.gov)

February 16, 2016

23/9/2014

Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: tofacitinib 5mg po bid

University of California, Los Angeles

NULL

Completed

18 Years

N/A

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

NCT03332719
(ClinicalTrials.gov)

February 2016

21/4/2016

Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis

Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Etanercept;Drug: Methotrexate

Gema Biotech S.A.

QUID-Quality in Drugs and Devices Latin American Consulting SRL

Completed

19 Years

99 Years

All

168

Phase 3

Argentina

237

EUCTR2015-002809-12-BG
(EUCTR)

27/01/2016

02/12/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India

238

NCT02640612
(ClinicalTrials.gov)

January 22, 2016

18/12/2015

Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab

Arthritis, Rheumatoid

Drug: BI 695501

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

430

Phase 3

United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine

239

EUCTR2015-002634-41-PL
(EUCTR)

20/01/2016

16/12/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of

240

EUCTR2014-000358-13-DE
(EUCTR)

14/01/2016

31/07/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

EUCTR2015-002634-41-HU
(EUCTR)

07/01/2016

16/10/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

242

NCT02636907
(ClinicalTrials.gov)

January 6, 2016

18/12/2015

Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe

Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe

Arthritis, Rheumatoid

Drug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringe

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

Phase 2

United States;Poland;Ukraine

243

EUCTR2014-000352-29-HR
(EUCTR)

29/12/2015

01/02/2016

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

244

EUCTR2015-002809-12-ES
(EUCTR)

23/12/2015

30/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

245

JPRN-jRCT2071200058

21/12/2015

25/11/2020

Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects

A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study

Rheumatoid arthritis;D001172

Yonemura Takuma

NULL

Complete

>= 20age old

< 45age old

Male

130

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

246

EUCTR2015-004173-32-DK
(EUCTR)

18/12/2015

20/10/2015

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.

Rheumatic diseases
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Benepali
INN or Proposed INN: ETANERCEPT
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Department of Clinical Biochemestry, Aarhus University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 4

Denmark

247

EUCTR2015-002634-41-ES
(EUCTR)

17/12/2015

30/10/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

248

NCT02837146
(ClinicalTrials.gov)

December 2015

7/7/2016

Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis

Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)

Rheumatoid Arthritis

Biological: Tocilizumab (TCZ);Drug: Methotrexate (MTX)

Maria Stoenoiu

NULL

Recruiting

18 Years

75 Years

Both

Phase 3

Belgium

249

EUCTR2015-002809-12-CZ
(EUCTR)

27/11/2015

02/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

250

NCT02557100
(ClinicalTrials.gov)

November 19, 2015

4/9/2015

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 4

United States;Canada;Mexico;Algeria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

251

NCT02512575
(ClinicalTrials.gov)

November 18, 2015

6/7/2015

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.

Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis

Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

55 Years

Male

Phase 1

Germany

252

NCT03172325
(ClinicalTrials.gov)

November 18, 2015

24/5/2017

Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis

A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis

Active Rheumatoid Arthritis

Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone

Cinnagen

NULL

Completed

18 Years

75 Years

All

136

Phase 3

NULL

253

EUCTR2015-002809-12-LV
(EUCTR)

17/11/2015

21/09/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

254

EUCTR2015-002809-12-HU
(EUCTR)

17/11/2015

26/08/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India

255

EUCTR2012-003876-38-PL
(EUCTR)

10/11/2015

16/11/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT

Rheumatoid Arthritis
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

256

EUCTR2014-000352-29-BG
(EUCTR)

21/10/2015

31/08/2015

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

257

EUCTR2015-001246-28-BE
(EUCTR)

19/10/2015

23/07/2015

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA

Trade Name: RoActemra
Product Name: RoActemra

Cliniques Universitaires Saint-Luc, Université catholique de Louvain

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

258

EUCTR2014-003307-30-GB
(EUCTR)

16/10/2015

25/08/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

102

Phase 2

Czech Republic;Hungary;Slovakia;Russian Federation;United Kingdom

259

EUCTR2014-000110-61-DE
(EUCTR)

15/10/2015

04/05/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE

Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

260

NCT02534311
(ClinicalTrials.gov)

October 13, 2015

25/8/2015

A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

NCT02605642
(ClinicalTrials.gov)

September 10, 2015

2/9/2015

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)

Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: CT-P13

Pfizer

Hospira, now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

351

Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy

262

NCT02717988
(ClinicalTrials.gov)

September 2015

4/3/2016

Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers

A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers

Rheumatoid Arthritis

Drug: SKI-O-703 capsule;Drug: Placebo capsule

Oscotec Inc.

PPD

Completed

18 Years

55 Years

All

Phase 1

United States

263

NCT02350426
(ClinicalTrials.gov)

August 12, 2015

15/12/2014

A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques

An Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques

Arthritis, Rheumatoid

Other: Gadobutrol;Other: 18F-FDG;Other: 18F-GE-180

GlaxoSmithKline

Cambridge University Hospitals NHS Foundation Trust

Terminated

30 Years

85 Years

All

Phase 1

United Kingdom

264

EUCTR2014-004887-39-PL
(EUCTR)

08/08/2015

07/07/2015

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Poland

265

NCT02797769
(ClinicalTrials.gov)

August 2015

8/6/2016

A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases

Rheumatoid Arthritis

Drug: Other Biologics;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Not yet recruiting

18 Years

N/A

Both

75000

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

266

NCT02481180
(ClinicalTrials.gov)

July 31, 2015

18/6/2015

Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

Rheumatoid Arthritis

Drug: T0001;Drug: Enbrel

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

NULL

Terminated

18 Years

65 Years

All

Phase 1

China

267

EUCTR2012-003876-38-HU
(EUCTR)

28/07/2015

22/05/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

268

EUCTR2012-003876-38-DE
(EUCTR)

21/07/2015

29/04/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

269

EUCTR2014-003034-42-BG
(EUCTR)

15/07/2015

11/05/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

270

EUCTR2014-003034-42-BE
(EUCTR)

13/07/2015

18/05/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

271

EUCTR2014-000110-61-ES
(EUCTR)

06/07/2015

01/06/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

272

NCT02518620
(ClinicalTrials.gov)

July 2015

6/8/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061

Rheumatoid Arthritis

Biological: ALX-0061

Ablynx

NULL

Completed

18 Years

74 Years

All

406

Phase 2

Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of

273

NCT02531178
(ClinicalTrials.gov)

July 2015

14/7/2015

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257

Rheumatoid Arthritis

Biological: ABBV-257;Biological: Placebo

AbbVie

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany

274

NCT02514772
(ClinicalTrials.gov)

July 2015

30/7/2015

GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Rheumatoid Arthritis

Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®

Sandoz

Hexal AG

Completed

18 Years

N/A

All

107

Phase 3

United States;Germany;Hungary;Poland

275

EUCTR2014-003034-42-DE
(EUCTR)

29/06/2015

18/03/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

NCT02480153
(ClinicalTrials.gov)

June 25, 2015

19/6/2015

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Rheumatoid Arthritis

Biological: PF-06410293;Biological: Adalimumab

Pfizer

NULL

Completed

18 Years

N/A

All

597

Phase 3

United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic

277

EUCTR2014-003034-42-ES
(EUCTR)

19/06/2015

14/04/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

278

EUCTR2014-003012-36-BG
(EUCTR)

19/06/2015

12/03/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

279

EUCTR2014-003012-36-CZ
(EUCTR)

10/06/2015

05/01/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

280

EUCTR2014-000358-13-HR
(EUCTR)

08/06/2015

10/11/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1080

Phase 3b;Phase 4

United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

281

EUCTR2014-001471-31-DE
(EUCTR)

02/06/2015

04/02/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

282

EUCTR2015-000538-31-DE
(EUCTR)

01/06/2015

07/04/2015

Application into the joint of opioids in chronic arthritis of the knee joint

NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint

chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Morphine Hexal
INN or Proposed INN: Morphinsulfat
Other descriptive name: MORPHINE SULFATE
Trade Name: Triam 40 mg Lichtenstein
INN or Proposed INN: TRIAMCINOLONACETONID
Other descriptive name: TRIAMCINOLONACETONID EP

Charité University medicine Berlin

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

283

EUCTR2014-003012-36-ES
(EUCTR)

27/05/2015

02/02/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

284

EUCTR2014-003012-36-DE
(EUCTR)

21/05/2015

29/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

285

EUCTR2014-000110-61-CZ
(EUCTR)

11/05/2015

04/05/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

286

EUCTR2014-003034-42-HU
(EUCTR)

08/05/2015

03/03/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

287

EUCTR2013-004569-16-DE
(EUCTR)

07/05/2015

26/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy

288

EUCTR2014-005418-45-SE
(EUCTR)

04/05/2015

18/03/2015

Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)

Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE

Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE

Christine Bengtsson

Solveig Wållberg-Jonsson

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

289

EUCTR2011-004720-35-NO
(EUCTR)

04/05/2015

26/01/2015

Rheumatoid arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Metex
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Imurel
INN or Proposed INN: IMUREL
Other descriptive name: AZATHIOPRINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
INN or Proposed INN: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Plaquenil
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Sweden

290

NCT02566967
(ClinicalTrials.gov)

May 2015

1/10/2015

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target

Rheumatoid Arthritis

Drug: tofacitinib

Norman B. Gaylis, MD

NULL

Completed

18 Years

N/A

All

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

291

EUCTR2013-004569-16-GR
(EUCTR)

30/04/2015

29/01/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany

292

EUCTR2014-003307-30-HU
(EUCTR)

16/04/2015

22/01/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of

293

EUCTR2014-003307-30-SK
(EUCTR)

16/04/2015

02/02/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BUMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of

294

EUCTR2014-002541-22-DE
(EUCTR)

02/04/2015

09/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira , 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

295

NCT02800811
(ClinicalTrials.gov)

April 2015

20/5/2016

Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects

Rheumatoid Arthritis;Complication of Transplant

Drug: FR104;Drug: Placebo

OSE Immunotherapeutics

NULL

Completed

18 Years

60 Years

Both

Phase 1

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

296

NCT02423538
(ClinicalTrials.gov)

April 2015

7/4/2015

First-in-Human Single Ascending Dose of SHR0302

A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers

Rheumatoid Arthritis

Drug: SHR0302;Drug: SHR0302 placebo comparator

Jiangsu HengRui Medicine Co., Ltd.

NULL

Active, not recruiting

18 Years

45 Years

Both

Phase 1

China

297

NCT02430909
(ClinicalTrials.gov)

April 2015

27/4/2015

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Bimekizumab;Biological: Certolizumab Pegol;Other: Placebo

UCB Celltech

PRA Health Sciences

Completed

18 Years

70 Years

All

159

Phase 2

Czechia;Hungary;Moldova, Republic of;Poland;Russian Federation;Slovakia;United Kingdom;Czech Republic

298

NCT02378506
(ClinicalTrials.gov)

April 2015

13/2/2015

Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

188

Phase 3

Bulgaria;Croatia;Germany;Greece;Hungary;Poland;Serbia;Slovakia;South Africa;Russian Federation

299

NCT02499315
(ClinicalTrials.gov)

April 2015

10/4/2015

Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 357;Drug: Placebo

Amgen

NULL

Terminated

25 Years

70 Years

Female

Phase 1

United States

300

EUCTR2014-003307-30-CZ
(EUCTR)

31/03/2015

03/02/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

301

EUCTR2014-003012-36-BE
(EUCTR)

23/03/2015

18/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

302

EUCTR2014-001471-31-HU
(EUCTR)

23/03/2015

23/01/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

303

EUCTR2013-004569-16-BG
(EUCTR)

18/03/2015

05/01/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany

304

EUCTR2014-002541-22-GB
(EUCTR)

18/03/2015

09/01/2015

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

305

EUCTR2014-000352-29-FR
(EUCTR)

16/03/2015

18/06/2015

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

306

EUCTR2013-004569-16-HR
(EUCTR)

16/03/2015

29/04/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

307

EUCTR2014-003012-36-HU
(EUCTR)

10/03/2015

30/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

308

EUCTR2014-001471-31-CZ
(EUCTR)

04/03/2015

27/01/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

309

NCT02287922
(ClinicalTrials.gov)

March 2015

5/11/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate

Rheumatoid Arthritis

Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab

Ablynx

NULL

Completed

18 Years

74 Years

All

251

Phase 2

United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of

310

EUCTR2013-004148-49-FR
(EUCTR)

23/02/2015

18/06/2015

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Product Name: Infliximab -Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab -Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2014-001114-26-SE
(EUCTR)

18/02/2015

26/08/2014

A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

312

EUCTR2014-002541-22-ES
(EUCTR)

16/02/2015

22/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

340

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

313

EUCTR2014-001114-26-NL
(EUCTR)

13/02/2015

24/09/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden

314

EUCTR2014-002541-22-HU
(EUCTR)

11/02/2015

15/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

315

NCT02466581
(ClinicalTrials.gov)

February 3, 2015

29/5/2015

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity

Rheumatoid Arthritis

Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

Phase 4

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

316

EUCTR2013-004569-16-HU
(EUCTR)

03/02/2015

18/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

317

NCT02373202
(ClinicalTrials.gov)

February 2015

12/2/2015

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

N/A

All

Phase 3

Japan

318

NCT02357069
(ClinicalTrials.gov)

February 2015

29/1/2015

A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Arthritis, Rheumatoid

Drug: Enbrel;Drug: LBEC0101

LG Life Sciences

Mochida Pharmaceutical Company, Ltd.

Active, not recruiting

20 Years

75 Years

Both

372

Phase 3

Japan;Korea, Republic of

319

NCT02332590
(ClinicalTrials.gov)

February 2015

5/1/2015

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab)

Sanofi

Regeneron Pharmaceuticals

Active, not recruiting

18 Years

N/A

All

369

Phase 3

United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France

320

NCT02330445
(ClinicalTrials.gov)

February 2015

18/12/2014

6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection

Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers

Arthritis, Rheumatoid

Drug: PRTX-100

Protalex, Inc.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

321

EUCTR2014-002541-22-CZ
(EUCTR)

26/01/2015

09/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

322

EUCTR2014-000109-11-DE
(EUCTR)

22/01/2015

08/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

730

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

323

EUCTR2014-000109-11-BG
(EUCTR)

21/01/2015

10/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

730

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

324

NCT03719469
(ClinicalTrials.gov)

January 20, 2015

6/9/2018

Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis

Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea

Rh Disease

Dietary Supplement: Green tea group

King Saud University

NULL

Completed

18 Years

85 Years

All

150

NULL

325

EUCTR2013-004569-16-SK
(EUCTR)

14/01/2015

21/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

EUCTR2011-002067-20-FR
(EUCTR)

13/01/2015

23/08/2012

Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.

A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -

Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany

327

EUCTR2014-000358-13-ES
(EUCTR)

13/01/2015

22/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany

328

EUCTR2013-005543-90-BG
(EUCTR)

06/01/2015

22/10/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

329

NCT02198651
(ClinicalTrials.gov)

January 5, 2015

22/7/2014

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases

Biological: Adalimumab;Other: Placebo

AbbVie

NULL

Completed

18 Years

N/A

All

149

Phase 4

United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom

330

EUCTR2014-000352-29-EE
(EUCTR)

05/01/2015

07/08/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

EUCTR2014-000109-11-CZ
(EUCTR)

18/12/2014

09/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

332

EUCTR2014-001114-26-GR
(EUCTR)

12/12/2014

02/12/2014

A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

333

EUCTR2014-001114-26-IE
(EUCTR)

11/12/2014

14/08/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

334

EUCTR2014-000352-29-DE
(EUCTR)

11/12/2014

13/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU
Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

335

NCT02328027
(ClinicalTrials.gov)

December 11, 2014

18/12/2014

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis

Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: 99mTc-rhAnnexin V-128

Advanced Accelerator Applications

NULL

Terminated

18 Years

N/A

All

Phase 1;Phase 2

Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

336

EUCTR2014-000109-11-ES
(EUCTR)

09/12/2014

04/11/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

337

EUCTR2014-000352-29-HU
(EUCTR)

05/12/2014

09/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

338

EUCTR2014-000358-13-CZ
(EUCTR)

04/12/2014

04/08/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

339

EUCTR2014-000358-13-PL
(EUCTR)

03/12/2014

24/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

340

EUCTR2013-001417-32-BG
(EUCTR)

27/11/2014

16/09/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H

Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

341

EUCTR2014-001114-26-GB
(EUCTR)

25/11/2014

14/08/2014

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

342

EUCTR2013-002622-23-GR
(EUCTR)

20/11/2014

23/10/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden

343

EUCTR2013-005543-90-DE
(EUCTR)

19/11/2014

16/06/2014

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: RITUXIMAB
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

344

EUCTR2014-002374-36-SE
(EUCTR)

19/11/2014

27/08/2014

A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity.

A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR

Rheumatoid arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Methotrexate
Trade Name: Metoject
Trade Name: Azathioprine
Trade Name: Leflunomide

The Karolinska Institutet, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 4

Sweden

345

EUCTR2014-001114-26-ES
(EUCTR)

17/11/2014

01/09/2014

Rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

346

EUCTR2014-001114-26-FR
(EUCTR)

13/11/2014

18/06/2015

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden

347

EUCTR2014-000358-13-EE
(EUCTR)

13/11/2014

07/08/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

348

EUCTR2014-000358-13-GB
(EUCTR)

12/11/2014

12/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

349

EUCTR2014-001114-26-DE
(EUCTR)

10/11/2014

08/08/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

350

EUCTR2014-000358-13-RO
(EUCTR)

10/11/2014

10/03/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1080

Phase 3b;Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

351

EUCTR2014-000352-29-LT
(EUCTR)

06/11/2014

08/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

352

EUCTR2014-000358-13-BG
(EUCTR)

06/11/2014

28/10/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

353

EUCTR2014-001114-26-AT
(EUCTR)

05/11/2014

10/10/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

354

EUCTR2014-001114-26-HU
(EUCTR)

04/11/2014

10/09/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

355

NCT02319642
(ClinicalTrials.gov)

November 2014

15/12/2014

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Pharma SA

Parexel

Completed

18 Years

N/A

All

347

Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

356

NCT02293902
(ClinicalTrials.gov)

November 2014

13/11/2014

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Rheumatoid Arthritis

Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

75 Years

All

243

Phase 3

Japan

357

NCT02287610
(ClinicalTrials.gov)

November 2014

6/11/2014

A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis

A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting

Rheumatoid Arthritis

Drug: RAYOS (delayed-release prednisone)

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

18 Years

N/A

All

N/A

NULL

358

NCT02030028
(ClinicalTrials.gov)

November 2014

6/1/2014

ACTH Gel Therapy in Rheumatoid Arthritis

Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ACTHAR gel

Dana Ascherman

Mallinckrodt

Recruiting

18 Years

100 Years

All

N/A

United States

359

EUCTR2014-000352-29-GB
(EUCTR)

29/10/2014

09/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

360

EUCTR2014-000352-29-CZ
(EUCTR)

27/10/2014

05/08/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

EUCTR2014-000352-29-ES
(EUCTR)

23/10/2014

29/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

362

EUCTR2013-004148-49-PL
(EUCTR)

21/10/2014

27/08/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

363

EUCTR2014-001114-26-IT
(EUCTR)

20/10/2014

16/09/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden

364

EUCTR2013-004148-49-BG
(EUCTR)

20/10/2014

01/09/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia

365

EUCTR2014-000706-34-GB
(EUCTR)

06/10/2014

18/07/2014

A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT

Product Name: tofacitinib citrate
Product Code: CP -690,550 – 10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

United States;Hungary;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

EUCTR2014-000358-13-LT
(EUCTR)

03/10/2014

11/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany

367

EUCTR2014-000358-13-LV
(EUCTR)

26/09/2014

11/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

368

EUCTR2011-005689-39-SK
(EUCTR)

24/09/2014

07/07/2014

A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

369

EUCTR2013-004555-21-GR
(EUCTR)

22/09/2014

21/03/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

370

EUCTR2011-004720-35-FI
(EUCTR)

10/09/2014

09/09/2014

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: METHOTREXATE DISODIUM
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Oxiklorin
Product Code: 118-42-3
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland;Denmark;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

EUCTR2013-005543-90-PL
(EUCTR)

09/09/2014

11/07/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

372

EUCTR2012-003654-86-BG
(EUCTR)

04/09/2014

21/05/2014

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

373

EUCTR2011-005689-39-NL
(EUCTR)

01/09/2014

23/06/2014

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of

374

NCT02222493
(ClinicalTrials.gov)

August 26, 2014

19/8/2014

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Biological: PF-06438179;Biological: Infliximab

Pfizer

NULL

Completed

18 Years

N/A

All

650

Phase 3

United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France

375

EUCTR2013-005543-90-HU
(EUCTR)

26/08/2014

13/05/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

EUCTR2013-004148-49-HU
(EUCTR)

13/08/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

377

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

378

NCT02308163
(ClinicalTrials.gov)

August 8, 2014

2/12/2014

A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: Peficitinib;Drug: Placebo;Biological: Etanercept

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

509

Phase 3

Japan;Korea, Republic of;Taiwan

379

EUCTR2013-002622-23-DE
(EUCTR)

06/08/2014

27/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

380

NCT02211469
(ClinicalTrials.gov)

August 2014

6/8/2014

A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

Rheumatoid Arthritis

Drug: BMS-986104;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

49 Years

Male

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

EUCTR2013-002622-23-ES
(EUCTR)

29/07/2014

25/04/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500
INN or Proposed INN: Not applicable

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

382

EUCTR2013-004148-49-DE
(EUCTR)

28/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany

383

NCT02305849
(ClinicalTrials.gov)

July 25, 2014

1/12/2014

A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Rheumatoid Arthritis

Drug: Peficitinib;Drug: Placebo;Drug: Methotrexate

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

519

Phase 3

Japan

384

EUCTR2013-004148-49-LT
(EUCTR)

14/07/2014

23/05/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina

385

EUCTR2013-004148-49-GB
(EUCTR)

03/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

NCT02151851
(ClinicalTrials.gov)

July 2014

28/5/2014

A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel Group, Randomized 24-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol (CZP) as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Biological: Certolizumab Pegol;Drug: Methotrexate;Other: Placebo

UCB Pharma SA, Belgium

Parexel

Completed

18 Years

N/A

All

430

Phase 3

China

387

NCT02011334
(ClinicalTrials.gov)

July 2014

4/12/2013

A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

285

Phase 3

Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay

388

EUCTR2013-001417-32-ES
(EUCTR)

30/06/2014

22/05/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden

389

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

390

EUCTR2013-002622-23-NL
(EUCTR)

24/06/2014

17/02/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500
INN or Proposed INN: Rituximab

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

391

EUCTR2013-004148-49-CZ
(EUCTR)

20/06/2014

05/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

392

EUCTR2013-001417-32-LT
(EUCTR)

19/06/2014

07/04/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of

393

EUCTR2013-002622-23-HU
(EUCTR)

03/06/2014

02/04/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

394

EUCTR2013-001417-32-DE
(EUCTR)

02/06/2014

18/02/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

395

EUCTR2013-002790-22-HU
(EUCTR)

02/06/2014

03/04/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

396

NCT02147587
(ClinicalTrials.gov)

June 2014

22/5/2014

A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment

Rheumatoid Arthritis

Drug: Tofacitinib;Drug: Placebo

Pfizer

NULL

Completed

50 Years

N/A

All

112

Phase 2

United States;United Kingdom

397

NCT02277574
(ClinicalTrials.gov)

June 2014

23/7/2014

Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: AMP -110;Other: Placebo

MedImmune LLC

Daiichi Sankyo Co., Ltd.

Completed

18 Years

75 Years

Both

Phase 1

United States

398

NCT02121210
(ClinicalTrials.gov)

June 2014

21/4/2014

To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: sarilumab SAR153191 (REGN88)

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

132

Phase 3

United States;Chile;Czechia;Estonia;Hungary;Poland;Russian Federation;Czech Republic

399

EUCTR2013-002790-22-EE
(EUCTR)

30/05/2014

07/05/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile

400

EUCTR2011-004720-35-DK
(EUCTR)

28/05/2014

24/02/2014

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Netherlands;Norway;Iceland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

EUCTR2013-001417-32-HU
(EUCTR)

27/05/2014

17/03/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of

402

EUCTR2013-003493-27-GR
(EUCTR)

27/05/2014

16/04/2014

Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.

A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201

Product Code: QAL964
Other descriptive name: QAL964

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Greece;Ukraine;Romania;Russian Federation

403

EUCTR2012-003654-86-LV
(EUCTR)

26/05/2014

24/04/2014

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone.

moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand

404

EUCTR2013-002790-22-CZ
(EUCTR)

21/05/2014

08/04/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile

405

EUCTR2013-002622-23-PT
(EUCTR)

09/05/2014

28/02/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

Serbia;United States;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

EUCTR2013-005013-13-BG
(EUCTR)

28/04/2014

23/04/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Phase 3

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

407

EUCTR2013-005013-13-LT
(EUCTR)

08/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

408

EUCTR2013-003493-27-HU
(EUCTR)

08/04/2014

30/01/2014

Product Code: QAL964
Other descriptive name: QAL964

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Ukraine;Russian Federation

409

EUCTR2013-004555-21-SK
(EUCTR)

07/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

410

EUCTR2013-004555-21-AT
(EUCTR)

07/04/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

411

NCT04582084
(ClinicalTrials.gov)

April 4, 2014

3/10/2020

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: Etanercept

AryoGen Pharmed Co.

NULL

Completed

18 Years

N/A

All

583

Iran, Islamic Republic of

412

EUCTR2013-005013-13-CZ
(EUCTR)

03/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

413

EUCTR2013-002622-23-BE
(EUCTR)

02/04/2014

26/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

414

EUCTR2013-004555-21-HU
(EUCTR)

02/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany

415

EUCTR2013-004555-21-DE
(EUCTR)

31/03/2014

17/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2013-002622-23-BG
(EUCTR)

27/03/2014

21/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

417

EUCTR2013-004555-21-PT
(EUCTR)

24/03/2014

07/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

418

EUCTR2013-004555-21-LV
(EUCTR)

03/03/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina

419

NCT02029599
(ClinicalTrials.gov)

March 2014

26/12/2013

The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fang yi qing feng shi granule;Drug: placebo;Drug: Methotrexate;Drug: Acetaminophen tablets

Maoxiang Group Jilin Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

65 Years

Both

240

Phase 2

China

420

EUCTR2013-004051-20-ES
(EUCTR)

26/02/2014

27/12/2013

NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY

RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: ROACTEMRA

FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA

NULL

Not Recruiting

Female: yes
Male: yes

122

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

EUCTR2012-003654-86-AT
(EUCTR)

26/02/2014

08/07/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;United States;Spain;Guatemala;Ukraine;Lithuania;Austria;Israel;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;New Zealand

422

NCT02169544
(ClinicalTrials.gov)

January 31, 2014

14/5/2014

Post-marketing Study Assessing the Long-Term Safety of Abatacept

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

100000

N/A

NULL

423

EUCTR2011-005689-39-DE
(EUCTR)

20/01/2014

24/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

424

JPRN-UMIN000012364

2014/01/10

25/11/2013

Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.

rheumatoid arthritis

Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief.
Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows;
*Day1-Day7(1 tablet/day, after night meal)
*Day8-Day14(1 tabletX2 times /day, after morning and night meal)
*Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal
*Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime)
Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks.

Osaka City University Medical School, Department of Orthopedic Surgery

NULL

Complete: follow-up complete

25years-old

75years-old

Male and Female

Not applicable

Japan

425

NCT01988506
(ClinicalTrials.gov)

January 6, 2014

7/11/2013

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis

Drug: Interleukin 2

Assistance Publique - Hôpitaux de Paris

Iltoo Pharma

Active, not recruiting

18 Years

N/A

All

Phase 2

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

426

NCT01988012
(ClinicalTrials.gov)

January 2014

31/10/2013

A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.

An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients.

Rheumatoid Arthritis

Biological: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Israel

427

JPRN-UMIN000012073

2013/12/01

21/10/2013

Effects of Subcutaneous Actemura and MTX Blending in RA

rheumatoid arthritis

Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks.
Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.

Department of Orthopaedic Surgery,Graduate School of Medicine, Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

85years-old

Male and Female

100

Phase 4

Japan

428

NCT02047604
(ClinicalTrials.gov)

December 2013

22/1/2014

(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Rheumatoid Arthritis

Drug: SAN-300;Drug: Placebo

Valeant Pharmaceuticals International, Inc.

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

429

NCT01941095
(ClinicalTrials.gov)

November 20, 2013

30/8/2013

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Greece

430

EUCTR2013-001999-38-PL
(EUCTR)

17/11/2013

11/10/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

NCT02005757
(ClinicalTrials.gov)

November 2013

4/12/2013

Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)

Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug

Rheumatoid Arthritis

Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg

Chong Kun Dang Pharmaceutical

NULL

Recruiting

20 Years

80 Years

Both

Phase 2

Korea, Republic of

432

NCT02027298
(ClinicalTrials.gov)

November 2013

18/11/2013

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study

Primary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid Arthritis

Drug: Abatacept

The Cleveland Clinic

Bristol-Myers Squibb

Withdrawn

18 Years

N/A

All

Phase 2

United States

433

EUCTR2013-001999-38-HU
(EUCTR)

30/10/2013

16/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 2

Serbia;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

434

EUCTR2013-001999-38-CZ
(EUCTR)

30/10/2013

24/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

435

EUCTR2013-002429-52-IE
(EUCTR)

23/10/2013

15/08/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab SC
Other descriptive name: TOCILIZUMAB SC

Roche Farma S.A

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

EUCTR2013-002429-52-PT
(EUCTR)

21/10/2013

08/08/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Roche Farma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

437

JPRN-UMIN000012399

2013/10/16

26/11/2013

Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis

Rheumatoid arthritis

Patients with active rheumatoid arthritis
(1)Assessment of tender and swollen joints by physical examination
(2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Gadolinium-enhanced MRI of the hand with more severe arthritis
(4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)
Healthy subjects
(1)Assessment of tender and swollen joints by physical examination
(2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)

Tokyo Medical and Dental University

Diagnostic Imaging Center, Ochanomizu Surugadai Clinic

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

438

NCT01894516
(ClinicalTrials.gov)

October 8, 2013

4/7/2013

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

Rheumatoid Arthritis

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

N/A

All

287

Phase 2

United States;Argentina;Australia;Austria;Bulgaria;Chile;Colombia;Germany;Guatemala;Hungary;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine

439

EUCTR2013-001999-38-BE
(EUCTR)

07/10/2013

11/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

440

JPRN-JapicCTI-132277

01/10/2013

AMG 162 Phase III study (DESIRABLE study)

A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)

rheumatoid arthritis

Intervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection

DAIICHISANKYO Co.,Ltd.

NULL

BOTH

642

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

441

NCT01962974
(ClinicalTrials.gov)

October 2013

11/10/2013

A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)

Arthritis, Rheumatoid

Biological: Golimumab 2 mg/kg IV

Janssen Biotech, Inc.

NULL

Terminated

18 Years

76 Years

All

Phase 3

United States;Canada;Argentina;Brazil;Colombia;Mexico

442

NCT01962337
(ClinicalTrials.gov)

October 2013

10/10/2013

Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis

Healthy;Rheumatoid Arthritis

Drug: FPA008;Drug: Placebo

Five Prime Therapeutics, Inc.

NULL

Terminated

21 Years

70 Years

All

Phase 1

Hungary;Netherlands;Poland

443

NCT01975610
(ClinicalTrials.gov)

October 2013

29/10/2013

Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis

A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CC -292;Drug: Placebo

Celgene

NULL

Completed

18 Years

80 Years

Female

Phase 2

United States

444

NCT01966718
(ClinicalTrials.gov)

October 2013

14/10/2013

Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action

Rheumatoid Arthritis

Drug: Repository corticotropin injection

Arthritis Treatment Center, Maryland

NULL

Completed

18 Years

80 Years

All

Phase 4

United States

445

EUCTR2012-003654-86-DE
(EUCTR)

26/09/2013

03/06/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

446

EUCTR2013-000359-42-GR
(EUCTR)

12/09/2013

27/08/2013

Not applicable

Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04

ROCHE HELLAS S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Greece

447

NCT01907230
(ClinicalTrials.gov)

September 10, 2013

14/7/2013

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial

Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus

Drug: Entecavir

Taipei Veterans General Hospital, Taiwan

NULL

Active, not recruiting

20 Years

90 Years

All

115

Phase 4

Taiwan

448

NCT01941940
(ClinicalTrials.gov)

September 5, 2013

2/9/2013

A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants

A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

227

Phase 3

Italy

449

EUCTR2012-003654-86-ES
(EUCTR)

03/09/2013

12/07/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Germany;Latvia;New Zealand

450

NCT01995201
(ClinicalTrials.gov)

September 2013

1/11/2013

A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

N/A

Both

401

Phase 3

Ireland;Portugal;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

NCT02072200
(ClinicalTrials.gov)

September 2013

14/2/2014

Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)

A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness

Rheumatoid Arthritis

Drug: Lodotra®

Mundipharma Korea Ltd

NULL

Completed

20 Years

80 Years

All

147

Phase 4

Korea, Republic of

452

NCT01948388
(ClinicalTrials.gov)

September 2013

9/9/2013

The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging

Rheumatoid Arthritis

Drug: corticotrophin 80 units

Gaylis, Norman B., M.D.

NULL

Completed

18 Years

N/A

All

Phase 4

United States

453

EUCTR2013-002429-52-ES
(EUCTR)

23/08/2013

12/07/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Roche Farma S.A

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

454

EUCTR2012-002181-12-SE
(EUCTR)

19/08/2013

09/07/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden

455

EUCTR2012-005026-30-HU
(EUCTR)

15/08/2013

20/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel ®
Product Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc

Samsung Bioepis Co., Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

456

EUCTR2012-003654-86-HU
(EUCTR)

15/08/2013

17/05/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

457

EUCTR2012-002181-12-AT
(EUCTR)

08/08/2013

25/06/2013

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Product Name: MK-8457
Product Code: MK-8457
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden

458

EUCTR2011-005689-39-CZ
(EUCTR)

07/08/2013

23/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

459

EUCTR2010-020892-22-NL
(EUCTR)

03/08/2013

10/08/2011

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

460

EUCTR2013-001569-17-IT
(EUCTR)

02/08/2013

04/06/2013

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

Roche S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3B

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

NCT01905735
(ClinicalTrials.gov)

August 2013

19/7/2013

A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .

Rheumatoid Arthritis.

Drug: Rhustoxicodendron 30;Drug: placebo

Healthcare Homoeo Charitable Society

NULL

Recruiting

25 Years

60 Years

Both

Phase 2

India

462

NCT01888874
(ClinicalTrials.gov)

July 17, 2013

26/6/2013

Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

N/A

All

599

Phase 2

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Russian Federation;Spain;Ukraine;Czech Republic;Peru;Puerto Rico

463

EUCTR2011-005689-39-HU
(EUCTR)

27/06/2013

22/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc, 235 East 42nd Street, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

464

EUCTR2011-005689-39-ES
(EUCTR)

26/06/2013

24/06/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Korea, Republic of

465

NCT01881308
(ClinicalTrials.gov)

June 17, 2013

17/6/2013

Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design

Rheumatoid Arthritis

Drug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDs

Diakonhjemmet Hospital

The Research Council of Norway;South-Eastern Norway Regional Health Authority

Active, not recruiting

18 Years

80 Years

All

360

Phase 4

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

466

NCT01875991
(ClinicalTrials.gov)

June 5, 2013

10/6/2013

Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept

Rheumatoid Arthritis;Plaque Psoriasis

Drug: Etanercept via Autoinjector A;Drug: Etanercept via Autoinjector B

Amgen

NULL

Completed

18 Years

N/A

All

217

Phase 4

United States;Canada

467

EUCTR2012-003536-23-PL
(EUCTR)

05/06/2013

22/04/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden

468

NCT01909427
(ClinicalTrials.gov)

June 2013

10/7/2013

An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: CNTO 6785 200 mg;Drug: CNTO 6785 100 mg;Drug: CNTO 6785 50 mg;Drug: CNTO 6785 15 mg

Janssen Research & Development, LLC

NULL

Completed

18 Years

80 Years

Both

257

Phase 2

Argentina;Colombia;Czech Republic;Philippines;Poland;Russian Federation;Thailand

469

EUCTR2012-003536-23-GB
(EUCTR)

21/05/2013

15/03/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

470

EUCTR2012-005026-30-PL
(EUCTR)

17/05/2013

08/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

471

EUCTR2012-005026-30-CZ
(EUCTR)

15/05/2013

22/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

472

NCT01927757
(ClinicalTrials.gov)

May 6, 2013

5/6/2013

Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab

A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent

Moderate to Severe Rheumatoid Arthritis

Biological: Etanercept;Drug: Methotrexate

Amgen

NULL

Terminated

18 Years

N/A

All

Phase 4

United States;Canada;Puerto Rico

473

EUCTR2012-003536-23-NL
(EUCTR)

01/05/2013

22/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary

474

NCT04157010
(ClinicalTrials.gov)

May 2013

15/4/2014

Tocilizumab REMission in Early RA

Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the Changes in Expression of Janus Kinase/Signal Transducers and Activators of Transcription (JAK-STAT) and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Methotrexate

University of Leeds

Hoffmann-La Roche

Completed

18 Years

N/A

All

Phase 4

United Kingdom

475

EUCTR2011-003538-16-PL
(EUCTR)

23/04/2013

08/03/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

476

EUCTR2011-002894-48-NO
(EUCTR)

11/04/2013

06/09/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

477

EUCTR2012-005026-30-BG
(EUCTR)

10/04/2013

05/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

478

EUCTR2012-003536-23-NO
(EUCTR)

09/04/2013

12/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

479

EUCTR2011-004017-17-GB
(EUCTR)

08/04/2013

11/01/2013

Tocilizumab and Remission in early rheumatoid arthritis

Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

The University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

480

EUCTR2012-003536-23-SE
(EUCTR)

08/04/2013

07/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

481

EUCTR2012-003536-23-BE
(EUCTR)

04/04/2013

07/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden

482

EUCTR2012-003057-29-CZ
(EUCTR)

02/04/2013

12/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients

XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: XmAb5871_10.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_3.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_1.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_0.3MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Slovakia

483

EUCTR2012-003536-23-ES
(EUCTR)

01/04/2013

04/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

484

JPRN-UMIN000009887

2013/04/01

01/04/2013

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Rheumatoid Arthritis

When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.

Department of Orthopaedic surgery, Tohoku University Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

485

NCT01850680
(ClinicalTrials.gov)

April 2013

1/5/2013

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Rheumatoid Arthritis

Drug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acid

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

65 Years

Both

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

486

NCT01878123
(ClinicalTrials.gov)

April 2013

22/5/2013

Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: AMP -110;Other: Placebo

MedImmune LLC

Daiichi Sankyo Co., Ltd.;Daiichi Sankyo Co., Ltd.

Completed

18 Years

75 Years

Both

Phase 1

United States

487

EUCTR2011-003538-16-CZ
(EUCTR)

29/03/2013

08/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

488

EUCTR2011-002896-40-PL
(EUCTR)

29/03/2013

11/02/2013

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Rituximab -Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

489

EUCTR2012-003536-23-IT
(EUCTR)

29/03/2013

05/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

490

EUCTR2011-003538-16-DE
(EUCTR)

26/03/2013

10/12/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

491

EUCTR2011-002840-29-RO
(EUCTR)

25/03/2013

16/06/2016

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

492

EUCTR2012-005275-14-NO
(EUCTR)

19/03/2013

04/02/2013

Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs

Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND

Rheumatoid arthritis (RA)
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning
Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.
Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

493

EUCTR2011-003538-16-PT
(EUCTR)

14/03/2013

13/12/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

494

EUCTR2012-003536-23-EE
(EUCTR)

13/03/2013

12/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden

495

EUCTR2012-003536-23-FI
(EUCTR)

13/03/2013

19/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

496

EUCTR2012-003629-40-CZ
(EUCTR)

11/03/2013

23/11/2012

An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: CNTO6785
Product Code: CNTO6785
INN or Proposed INN: CNTO6785

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India

497

EUCTR2011-003538-16-IT
(EUCTR)

08/03/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab

SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand

498

EUCTR2012-003536-23-HU
(EUCTR)

07/03/2013

16/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

499

EUCTR2011-006021-23-PL
(EUCTR)

05/03/2013

04/01/2013

A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ASP015K
INN or Proposed INN: ASP015K
Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
INN or Proposed INN: ASP015K
Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany

500

EUCTR2011-006020-20-PL
(EUCTR)

05/03/2013

19/11/2012

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

501

EUCTR2011-006058-94-DE
(EUCTR)

04/03/2013

27/08/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2

Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

502

EUCTR2011-006018-15-PL
(EUCTR)

01/03/2013

16/11/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

503

NCT01768572
(ClinicalTrials.gov)

March 2013

11/1/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Rheumatoid Arthritis

Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

202

Phase 3

United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic

504

JPRN-UMIN000010126

2013/02/25

26/02/2013

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD

Interstitial lung disease related to rheumatoid arthritis

In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.

Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

505

EUCTR2012-003536-23-CZ
(EUCTR)

20/02/2013

03/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

506

EUCTR2011-003538-16-AT
(EUCTR)

19/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

507

EUCTR2012-005370-62-IT
(EUCTR)

18/02/2013

11/01/2013

clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes.

No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study.

rheumatoid arthritis and type 2 diabetes mellitus as comorbidity.
MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859
MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: KINERET *SC 7SIR 100MG 0,67ML
INN or Proposed INN: ANAKINRA

OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Italy

508

EUCTR2011-003538-16-GR
(EUCTR)

18/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand

509

EUCTR2011-003538-16-HU
(EUCTR)

14/02/2013

14/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

510

EUCTR2011-006344-71-DE
(EUCTR)

08/02/2013

25/04/2012

Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate

Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study.

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Trichuris suis ova
Product Name: Trichuris suis ova
Product Code: TSO
INN or Proposed INN: Trichuris suis ova
Other descriptive name: Pig whipworm eggs

Immanuel Krankenhaus Berlin

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

511

EUCTR2011-006018-15-HU
(EUCTR)

06/02/2013

30/11/2012

Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Czech Republic;Hungary;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

512

EUCTR2011-002894-48-BG
(EUCTR)

06/02/2013

20/11/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

513

NCT01768858
(ClinicalTrials.gov)

February 5, 2013

14/1/2013

Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis

Drug: Adalimumab

AbbVie

Raffeiner GmbH

Completed

18 Years

99 Years

All

Austria

514

EUCTR2011-003538-16-LT
(EUCTR)

04/02/2013

05/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

515

EUCTR2011-006021-23-CZ
(EUCTR)

01/02/2013

06/12/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

516

EUCTR2011-003538-16-SK
(EUCTR)

29/01/2013

08/03/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

517

EUCTR2011-002894-48-DE
(EUCTR)

25/01/2013

24/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

518

EUCTR2011-006021-23-BG
(EUCTR)

25/01/2013

13/12/2012

A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015K

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia

519

EUCTR2011-002894-48-ES
(EUCTR)

18/01/2013

29/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695500
INN or Proposed INN: Not applicable
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

520

EUCTR2011-003538-16-ES
(EUCTR)

16/01/2013

29/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

521

EUCTR2011-006020-20-BG
(EUCTR)

11/01/2013

04/01/2013

A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA)

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

522

EUCTR2011-006018-15-BG
(EUCTR)

10/01/2013

28/12/2012

A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who are having insufficient relief from methotrexate

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

523

EUCTR2011-002067-20-GR
(EUCTR)

10/01/2013

13/12/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

524

NCT02089087
(ClinicalTrials.gov)

January 7, 2013

13/3/2014

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: CFZ533;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

Phase 1

United States;Taiwan

525

EUCTR2011-006021-23-HU
(EUCTR)

04/01/2013

24/10/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

NCT01793519
(ClinicalTrials.gov)

January 2013

14/2/2013

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial

Rheumatoid Arthritis

Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo

Georgetown University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.

Recruiting

18 Years

N/A

All

290

Phase 4

United States

527

NCT01765478
(ClinicalTrials.gov)

January 2013

7/1/2013

Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers

A Phase1 Study, to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered HM71224 in Healthy, Adult Male Volunteers

Rheumatoid Arthritis

Drug: HM71224 single ascending dose;Drug: HM71224 food effect;Drug: HM71224 Multiple ascending dose

Hanmi Pharmaceutical Company Limited

NULL

Completed

18 Years

65 Years

Male

Phase 1

Netherlands

528

NCT01491815
(ClinicalTrials.gov)

December 14, 2012

8/12/2011

Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction

A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment

Rheumatoid Arthritis

Drug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

812

Phase 4

Denmark;Finland;Iceland;Netherlands;Norway;Sweden

529

EUCTR2011-006018-15-CZ
(EUCTR)

12/12/2012

03/08/2012

Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

530

EUCTR2011-006020-20-CZ
(EUCTR)

12/12/2012

03/08/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

531

EUCTR2011-006058-94-PT
(EUCTR)

11/12/2012

23/10/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

532

JPRN-UMIN000009425

2012/12/06

01/12/2012

A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient

Rheumatoid Arthritis

The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.

Osaka City University Medical School

NULL

Recruiting

20years-old

Not applicable

Male and Female

150

Phase 4

Japan

533

EUCTR2011-006058-94-GR
(EUCTR)

04/12/2012

23/10/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of

534

EUCTR2011-005376-42-BG
(EUCTR)

03/12/2012

28/08/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Russian Federation;Bulgaria;Latvia

535

EUCTR2011-006021-23-BE
(EUCTR)

19/11/2012

25/10/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

EUCTR2011-002894-48-GR
(EUCTR)

16/11/2012

19/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden

537

EUCTR2012-003057-29-HU
(EUCTR)

13/11/2012

19/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

Product Name: XmAb5871_10.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_3.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_1.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_0.3MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Slovakia

538

EUCTR2012-003057-29-SK
(EUCTR)

12/11/2012

19/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.
MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Slovakia

539

EUCTR2011-002894-48-PT
(EUCTR)

09/11/2012

09/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
INN or Proposed INN: No Active Name Specified
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

540

NCT01689532
(ClinicalTrials.gov)

November 2012

18/9/2012

A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

Arthritis, Rheumatoid

Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo

Janssen Pharmaceutical K.K.

GlaxoSmithKline

Completed

20 Years

N/A

All

122

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

NCT01725230
(ClinicalTrials.gov)

November 2012

7/11/2012

Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib

An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

542

EUCTR2011-002840-29-CZ
(EUCTR)

31/10/2012

05/09/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

543

EUCTR2011-002840-29-HU
(EUCTR)

25/10/2012

04/09/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

544

EUCTR2011-002896-40-DE
(EUCTR)

23/10/2012

02/07/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US

NULL

Not Recruiting

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

545

EUCTR2011-002840-29-LV
(EUCTR)

22/10/2012

25/10/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2012-000535-36-PL
(EUCTR)

18/10/2012

13/09/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

547

EUCTR2011-002894-48-HU
(EUCTR)

16/10/2012

16/08/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

548

NCT01736189
(ClinicalTrials.gov)

October 11, 2012

27/11/2012

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)

Rheumatoid Arthritis

Drug: Adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

16 Years

99 Years

All

346

Japan

549

EUCTR2011-002894-48-EE
(EUCTR)

08/10/2012

08/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

550

JPRN-UMIN000010315

2012/10/01

26/03/2013

Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment

Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study

rheumatoid arthritis

In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.

Osaka City University Medical School

Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital.

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

551

JPRN-JapicCTI-132091

01/10/2012

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents

Rheumatoid Arthritis

Intervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : subcutaneously 75mg, 150mg
Control intervention name : null

Novartis Pharma K.K.

NULL

BOTH

234

Phase 3

NULL

552

NCT01709578
(ClinicalTrials.gov)

October 2012

15/10/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists

Rheumatoid Arthritis

Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

546

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong

553

NCT01770379
(ClinicalTrials.gov)

October 2012

16/10/2012

Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents.

Rheumatoid Arthritis

Biological: Secukinumab (AIN457);Biological: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

242

Phase 3

United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico

554

NCT01871961
(ClinicalTrials.gov)

October 2012

14/5/2013

Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery

Rheumatoid Arthritis (RA)

Drug: Methotrexate (Metoject® prefilled pen)

medac GmbH

PPD (CRO)

Completed

16 Years

N/A

Both

105

Phase 1

United States

555

NCT01711814
(ClinicalTrials.gov)

September 26, 2012

19/10/2012

A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

Arthritis, Rheumatoid

Drug: peficitinib

Astellas Pharma Global Development, Inc.

Janssen Biotech, Inc.

Completed

18 Years

N/A

All

611

Phase 2

United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

556

EUCTR2011-006058-94-CZ
(EUCTR)

26/09/2012

19/07/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

557

EUCTR2012-002181-12-DK
(EUCTR)

24/09/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Active rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Denmark;Peru;Australia;South Africa;New Zealand;Sweden

558

EUCTR2011-002894-48-GB
(EUCTR)

14/09/2012

06/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

559

EUCTR2011-002894-48-NL
(EUCTR)

10/09/2012

14/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

560

EUCTR2011-006020-20-HU
(EUCTR)

07/09/2012

29/06/2012

Rheumatoid Arthritis
MedDRA version: 15.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Czech Republic;Hungary;Mexico;Poland;Ukraine;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

EUCTR2012-000535-36-DE
(EUCTR)

05/09/2012

15/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

562

EUCTR2011-006058-94-IT
(EUCTR)

04/09/2012

13/09/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of

563

NCT01647451
(ClinicalTrials.gov)

September 2012

19/7/2012

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0114-0006;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 2

Bulgaria;Hungary;Latvia;Poland;Russian Federation;Serbia;Spain

564

EUCTR2011-006070-73-DE
(EUCTR)

28/08/2012

24/02/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany

565

EUCTR2012-000535-36-BE
(EUCTR)

28/08/2012

05/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

566

EUCTR2012-000535-36-SK
(EUCTR)

23/08/2012

14/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

567

EUCTR2011-002067-20-IT
(EUCTR)

23/08/2012

13/09/2012

Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

UCB PHARMA SA/NV.

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

568

EUCTR2011-002896-40-GB
(EUCTR)

14/08/2012

11/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

569

EUCTR2011-002894-48-BE
(EUCTR)

02/08/2012

18/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

Phase 1;Phase 3

570

EUCTR2012-000535-36-CZ
(EUCTR)

02/08/2012

18/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

571

NCT01870908
(ClinicalTrials.gov)

August 2012

4/6/2013

Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings

Rheumatoid Arthritis

Drug: tacrolimus;Drug: biological agents

Astellas Pharma Inc

NULL

Completed

N/A

Both

664

N/A

Japan

572

EUCTR2011-006018-15-BE
(EUCTR)

28/07/2012

02/07/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2

United States;Hungary;Czech Republic;Mexico;Poland;Belgium;Ukraine;Bulgaria;Colombia

573

EUCTR2011-004529-28-CZ
(EUCTR)

25/07/2012

03/04/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available

Rheumatoid Arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of

574

EUCTR2011-002067-20-GB
(EUCTR)

23/07/2012

13/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany

575

EUCTR2012-000439-17-GB
(EUCTR)

17/07/2012

16/04/2012

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy

active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457

Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck)

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

576

EUCTR2011-005376-42-LV
(EUCTR)

06/07/2012

13/03/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia

577

EUCTR2011-002067-20-PT
(EUCTR)

06/07/2012

21/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

578

NCT01554696
(ClinicalTrials.gov)

July 6, 2012

13/3/2012

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo;Drug: methotrexate

Astellas Pharma Inc

NULL

Completed

18 Years

N/A

All

379

Phase 2

United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic

579

JPRN-UMIN000008404

2012/07/01

12/07/2012

Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.

rheumatoid arthritis

Extension of Tocilizumab Dose Intervals

Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

580

NCT01793259
(ClinicalTrials.gov)

July 2012

14/2/2013

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe

medac GmbH

NULL

Completed

18 Years

75 Years

Both

120

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

581

NCT01640054
(ClinicalTrials.gov)

July 2012

2/7/2012

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Rheumatoid Arthritis

Drug: Fostamatinib

AstraZeneca

NULL

Terminated

18 Years

N/A

All

115

Phase 2

Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam

582

EUCTR2011-002067-20-BG
(EUCTR)

28/06/2012

11/05/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

583

EUCTR2011-005260-20-GB
(EUCTR)

28/06/2012

10/05/2012

RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.

Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER

Adult Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Roche Products Limited

NULL

Not Recruiting

Female: yes
Male: yes

618

Phase 4

United Kingdom

584

EUCTR2011-002067-20-AT
(EUCTR)

26/06/2012

27/03/2012

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

585

EUCTR2011-002067-20-ES
(EUCTR)

26/06/2012

10/05/2012

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

586

EUCTR2011-005204-15-AT
(EUCTR)

20/06/2012

15/05/2012

Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?

Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop

biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT

Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

Austria

587

NCT01565655
(ClinicalTrials.gov)

June 19, 2012

27/3/2012

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

N/A

All

289

Phase 2

United States;Bulgaria;Czechia;Hungary;Mexico;Poland;Czech Republic

588

EUCTR2011-002067-20-CZ
(EUCTR)

19/06/2012

25/04/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany

589

EUCTR2011-005376-42-ES
(EUCTR)

18/06/2012

29/03/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Russian Federation;Serbia;Bulgaria;Spain;Latvia;Poland

590

NCT01638013
(ClinicalTrials.gov)

June 13, 2012

9/7/2012

A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K

Arthritis, Rheumatoid

Drug: Peficitinib

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

843

Phase 3

Japan;Korea, Republic of;Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

591

EUCTR2011-002067-20-DE
(EUCTR)

13/06/2012

16/02/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

592

EUCTR2009-017998-37-BE
(EUCTR)

08/06/2012

11/04/2012

Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Ghent University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Belgium

593

EUCTR2011-002067-20-IE
(EUCTR)

01/06/2012

10/04/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany

594

EUCTR2011-004529-28-BG
(EUCTR)

01/06/2012

07/05/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

595

NCT01712178
(ClinicalTrials.gov)

June 2012

14/6/2012

A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety

Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab , current formulation;Biological: Adalimumab , new formulation

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

100

Phase 2

United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

596

NCT01602302
(ClinicalTrials.gov)

June 2012

16/5/2012

Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)

Medical University of Graz

NULL

Terminated

18 Years

90 Years

All

Phase 4

Austria

597

NCT02052375
(ClinicalTrials.gov)

June 2012

30/1/2014

A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis;Pharmacokinetics of ASP2408

Drug: ASP2408;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

598

EUCTR2012-000222-21-DE
(EUCTR)

31/05/2012

16/03/2012

Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.

An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA

Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Code: 70930.00.00
INN or Proposed INN: Methotrexate disodium
Product Name: methotrexate pre-filled pen
INN or Proposed INN: Methotrexate disodium

medac Gesellschaft für klinische Spezialpräparate mbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

599

EUCTR2011-002067-20-HU
(EUCTR)

30/05/2012

20/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

600

EUCTR2011-005376-42-HU
(EUCTR)

30/05/2012

11/04/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

601

EUCTR2011-004720-35-SE
(EUCTR)

28/05/2012

22/12/2011

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE

The Karolinska Institute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Sweden

602

EUCTR2011-006070-73-BG
(EUCTR)

22/05/2012

07/05/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany

603

EUCTR2011-006070-73-CZ
(EUCTR)

16/05/2012

29/02/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany

604

EUCTR2011-004529-28-PL
(EUCTR)

14/05/2012

28/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

605

NCT01559103
(ClinicalTrials.gov)

May 2012

19/3/2012

Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients

A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)

Rheumatoid Arthritis

Biological: MEDI5117;Biological: MEDI5117 Placebo

AstraZeneca

NULL

Terminated

20 Years

75 Years

Both

Phase 1

United States;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

NCT01617590
(ClinicalTrials.gov)

May 2012

28/5/2012

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: leflunomide;Drug: methotrexate

Shanxi Medical University

NULL

Recruiting

18 Years

75 Years

Both

500

N/A

China

607

JPRN-UMIN000009535

2012/04/25

12/12/2012

Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate

Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate - SCRUM study

rheumatoid arthritis

We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We observe the patients if there is no positive joint power Doppler signal.

Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

100years-old

Male and Female

120

Not selected

Japan

608

EUCTR2011-004529-28-HU
(EUCTR)

18/04/2012

01/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of

609

JPRN-UMIN000011087

2012/04/11

01/07/2013

Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates

Osteoporosis

Minodronic acid (50mg/month or 1mg/day)

Osaka University Graduate School of Medicine

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

610

EUCTR2011-002392-41-BG
(EUCTR)

09/04/2012

07/02/2012

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

611

JPRN-UMIN000007432

2012/04/01

02/03/2012

Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.

rheumatoid arthritis

Infliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.

Keio University

NULL

Complete: follow-up continuing

20years-old

75years-old

Male and Female

100

Not selected

Japan

612

NCT01563978
(ClinicalTrials.gov)

April 2012

23/3/2012

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

266

Phase 2

United States;Bulgaria;Czech Republic;Germany;Poland;South Africa;Ukraine;Argentina;Mexico;Peru

613

NCT01569074
(ClinicalTrials.gov)

April 2012

30/3/2012

Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Placebo

AstraZeneca

NULL

Terminated

18 Years

N/A

All

163

Phase 2

Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam

614

NCT02171143
(ClinicalTrials.gov)

April 2012

18/6/2014

A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis;Pharmacokinetics of ASP2409

Drug: ASP2409;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

615

NCT01557374
(ClinicalTrials.gov)

April 2012

16/3/2012

TOward the Lowest Effective DOse of Abatacept or Tocilizumab

Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy

Rheumatoid Arthritis

Drug: Tocilizumab , Abatacept;Drug: Decrease Tocilizumab, Abatacept

Assistance Publique - Hôpitaux de Paris

Ministry of Health, France

Active, not recruiting

18 Years

N/A

All

232

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2011-002392-41-HU
(EUCTR)

28/03/2012

16/12/2011

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

617

NCT01526057
(ClinicalTrials.gov)

March 20, 2012

1/2/2012

A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

Rheumatoid Arthritis

Biological: PF-05280586;Biological: MabThera;Biological: Rituxan

Pfizer

NULL

Completed

18 Years

N/A

All

220

Phase 2

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan

618

NCT01649999
(ClinicalTrials.gov)

March 1, 2012

23/7/2012

A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo

Astellas Pharma Inc

NULL

Completed

20 Years

75 Years

All

281

Phase 2

Japan

619

NCT01582880
(ClinicalTrials.gov)

March 2012

10/4/2012

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Chemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune Diseases

Drug: Riboflavin

Joseph B. Ciolino, MD

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

620

EUCTR2011-002024-40-ES
(EUCTR)

16/02/2012

14/10/2011

Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Product Name: CCR1 Antagonist
Product Code: BMS-817399

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

172

Russian Federation;Mexico;Argentina;Korea, Republic of;Spain;United States;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

621

EUCTR2011-000311-34-IT
(EUCTR)

03/02/2012

06/12/2011

GO-AHEAD

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD

Active Axial Spondyloarthritis (SpA)
MedDRA version: 14.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy

622

JPRN-UMIN000006702

2012/02/01

11/11/2011

A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis

rheumatoid arthritis

Intensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.

Tokyo Medical and Dental University

Department of Pharmacovigilance

Complete: follow-up continuing

20years-old

70years-old

Male and Female

290

Not applicable

Japan

623

NCT01587989
(ClinicalTrials.gov)

February 2012

12/3/2012

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Austria

624

NCT01646385
(ClinicalTrials.gov)

February 2012

12/4/2012

Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data

Rheumatoid Arthritis

Drug: etanercept;Drug: non-biologic anti-rheumatic drugs

Pfizer

NULL

Completed

18 Years

N/A

All

6393

N/A

NULL

625

EUCTR2010-023782-22-SK
(EUCTR)

25/01/2012

07/10/2011

A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG

A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG

Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

626

EUCTR2011-002849-36-LV
(EUCTR)

12/01/2012

22/11/2011

A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available

Product Name: JNJ-39758979 -AAC - enteric coated tablet - 10 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Product Name: JNJ-39758979 -AAC - enteric coated tablet - 30 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Product Name: JNJ-39758979 -AAC - enteric coated tablet - 100 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

325

Phase 2b

United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan

627

NCT01533714
(ClinicalTrials.gov)

January 2012

10/2/2012

The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis

Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083

Rheumatoid Arthritis

Biological: Olokizumab

UCB Pharma

NULL

Completed

20 Years

N/A

Both

103

Phase 2

Japan;Korea, Republic of;Taiwan

628

NCT01474291
(ClinicalTrials.gov)

January 2012

15/11/2011

An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

Rheumatoid Arthritis

Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

608

N/A

France;Monaco

629

EUCTR2010-023782-22-BG
(EUCTR)

21/12/2011

21/05/2012

Rheumatoid Arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of

630

EUCTR2010-023782-22-ES
(EUCTR)

16/12/2011

20/07/2011

Rheumatoid Arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer, S.L.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

315

Phase 2

Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

631

EUCTR2010-023782-22-DE
(EUCTR)

13/12/2011

16/09/2011

Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

632

EUCTR2011-000436-28-PL
(EUCTR)

07/12/2011

20/06/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation

633

NCT01511003
(ClinicalTrials.gov)

December 5, 2011

4/1/2012

A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

20 Years

75 Years

All

128

Phase 4

Korea, Republic of

634

NCT01443364
(ClinicalTrials.gov)

December 2011

27/9/2011

Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: Certolizumab pegol

UCB Italy s.p.a.

NULL

Completed

18 Years

N/A

All

132

Phase 4

Italy

635

NCT01500278
(ClinicalTrials.gov)

December 2011

22/12/2011

Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

Rheumatoid Arthritis

Biological: Certolizumab Pegol (CZP);Biological: Adalimumab (ADA);Drug: Methotrexate (MTX)

UCB Pharma SA

Parexel

Completed

18 Years

N/A

All

915

Phase 4

United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Monaco;Poland;Portugal;Romania;Spain;Switzerland;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

636

EUCTR2011-000275-13-BE
(EUCTR)

29/11/2011

20/10/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

637

EUCTR2011-005036-26-GB
(EUCTR)

29/11/2011

31/10/2011

A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases

An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease

AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10003553;Term: Asthma;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: FX125L

Funxional Therapeutics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

United Kingdom

638

EUCTR2010-023782-22-HU
(EUCTR)

22/11/2011

27/09/2011

Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

639

EUCTR2010-024516-34-BG
(EUCTR)

09/11/2011

07/09/2011

Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate

A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Slovakia;Canada;Bulgaria;Italy

640

EUCTR2011-000102-21-BG
(EUCTR)

09/11/2011

01/09/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

NCT01408602
(ClinicalTrials.gov)

November 2011

2/8/2011

A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients

A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MRC375;Drug: Matching Placebo;Drug: MRC375 150mg

Molecular Research Center, Inc.

Camargo Pharmaceutical Services;Clin Data Services;Harrison Clinical Research;BARC Global Central Laboratory;Bilcare Global Clinical Supplies

Active, not recruiting

18 Years

N/A

Both

300

Phase 2

United States

642

EUCTR2011-000102-21-DE
(EUCTR)

20/10/2011

09/08/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

643

NCT01451203
(ClinicalTrials.gov)

October 11, 2011

25/9/2011

Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors

Rheumatoid Arthritis

Drug: Placebo;Drug: CZP;Drug: methotrexate (MTX)

Astellas Pharma Inc

UCB Japan Co. Ltd.

Completed

20 Years

64 Years

All

319

Phase 3

Japan

644

EUCTR2011-000436-28-BG
(EUCTR)

07/10/2011

06/10/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

645

NCT01463059
(ClinicalTrials.gov)

October 2011

27/10/2011

Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

Rheumatoid Arthritis

Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg

UCB Japan Co. Ltd.

NULL

Completed

20 Years

N/A

Both

119

Phase 2

Japan;Korea, Republic of;Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

646

NCT01954381
(ClinicalTrials.gov)

October 2011

13/10/2011

Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Device: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samples

Assistance Publique Hopitaux De Marseille

NULL

Completed

18 Years

N/A

Both

Phase 3

France

647

NCT01436370
(ClinicalTrials.gov)

October 2011

15/9/2011

TIV and High Dose TIV in Subjects With Rheumatoid Arthritis

A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels

Influenza

Biological: Trivalent inactivated influenza vaccine

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

18 Years

64 Years

All

102

Phase 2

United States

648

NCT01641952
(ClinicalTrials.gov)

October 2011

13/7/2012

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

505

N/A

Romania

649

EUCTR2010-024516-34-SK
(EUCTR)

29/09/2011

13/04/2012

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Slovakia;Canada;Bulgaria;Italy

650

EUCTR2011-000102-21-SK
(EUCTR)

22/09/2011

28/06/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

651

EUCTR2010-023782-22-CZ
(EUCTR)

21/09/2011

01/08/2011

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

652

EUCTR2010-023692-26-SK
(EUCTR)

09/09/2011

13/09/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4

Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

653

NCT01399697
(ClinicalTrials.gov)

September 2011

20/7/2011

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

261

Phase 4

Spain

654

NCT01374971
(ClinicalTrials.gov)

September 2011

14/6/2011

Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression

Rheumatoid Arthritis

Drug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsy

Nathan Wei, MD, FACP, FACR:

University of California, San Diego

Completed

18 Years

N/A

All

Phase 3

United States

655

NCT01350804
(ClinicalTrials.gov)

September 2011

9/5/2011

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1)

A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

Rheumatoid Arthritis

Biological: AIN457;Biological: Placebo;Biological: Abatacept

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

551

Phase 3

United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

656

NCT01404585
(ClinicalTrials.gov)

September 2011

27/7/2011

Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: BMS-817399

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

123

Phase 2

United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain

657

NCT02164214
(ClinicalTrials.gov)

September 2011

4/7/2013

Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?

DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?

Inflammatory Rheumatism;Psoriatic Arthritis;Rheumatoid Arthritis

Drug: etanercept Treatment

Assistance Publique Hopitaux De Marseille

NULL

Completed

18 Years

N/A

Both

Phase 3

France

658

NCT01393639
(ClinicalTrials.gov)

September 2011

13/6/2011

Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug.

Rheumatoid Arthritis

Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

323

Phase 2

United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic

659

NCT01359150
(ClinicalTrials.gov)

September 2011

11/5/2011

A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate

Rheumatoid Arthritis

Drug: CP -690,550;Drug: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

223

Phase 2

United States;Poland

660

EUCTR2010-020745-27-HU
(EUCTR)

31/08/2011

11/07/2011

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

661

EUCTR2010-024516-34-HU
(EUCTR)

31/08/2011

29/06/2011

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Canada;Bulgaria;Italy

662

NCT01377012
(ClinicalTrials.gov)

August 30, 2011

17/6/2011

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa Agents

A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)

Rheumatoid Arthritis

Biological: Secukinumab (AIN457);Biological: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

637

Phase 3

United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania

663

EUCTR2011-000385-35-IT
(EUCTR)

19/08/2011

27/02/2012

MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY

Trade Name: CIMZIA
INN or Proposed INN: CERTOLUZIMAB PEGOL
Other descriptive name: NA

UCB PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

664

EUCTR2011-000102-21-CZ
(EUCTR)

19/08/2011

27/05/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

665

EUCTR2010-022378-15-GB
(EUCTR)

18/08/2011

10/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

666

EUCTR2011-000436-28-HU
(EUCTR)

02/08/2011

10/08/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

667

NCT01414101
(ClinicalTrials.gov)

August 2011

21/7/2011

Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ISIS CRP Rx or Placebo

Isis Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

Phase 2

Canada;Russian Federation

668

NCT01390545
(ClinicalTrials.gov)

August 2011

5/7/2011

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

Rheumatoid Arthritis

Drug: Veltuzumab

Takeda

NULL

Terminated

18 Years

N/A

Both

300

Phase 2

United States;Argentina;Canada;Czech Republic;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom

669

EUCTR2011-000275-13-HU
(EUCTR)

29/07/2011

10/06/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

670

EUCTR2011-001863-39-AT
(EUCTR)

28/07/2011

15/06/2011

A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.

A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE

Mild to moderate rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexat Lederle 2.5mg tablets
Product Name: Methotrexat
Product Code: RO0029893
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

Roche Austria GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

EUCTR2010-024516-34-IT
(EUCTR)

25/07/2011

29/12/2011

A randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate

Product Name: Secukinumab
Product Code: AIN457F
Other descriptive name: Secukinumab

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Canada;Bulgaria;Italy

672

EUCTR2011-000275-13-GB
(EUCTR)

20/07/2011

18/07/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

673

EUCTR2011-000102-21-HU
(EUCTR)

14/07/2011

08/06/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

674

NCT01390441
(ClinicalTrials.gov)

July 2011

7/7/2011

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: MK-8808;Biological: MabThera ® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

100

Phase 1

Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States

675

EUCTR2011-000275-13-IT
(EUCTR)

28/06/2011

23/02/2012

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs.

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

EUCTR2011-000102-21-IT
(EUCTR)

28/06/2011

09/01/2012

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents

Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: Secukinumab
Trade Name: ORENCIA *IV 2FL 250MG+2SIR
INN or Proposed INN: ABATACEPT

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

677

EUCTR2008-001523-57-NO
(EUCTR)

10/06/2011

23/09/2008

Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

678

NCT01355354
(ClinicalTrials.gov)

June 2011

17/5/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Healthy Volunteers;Rheumatoid Arthritis

Drug: Digoxin;Drug: Fostamatinib

AstraZeneca

NULL

Completed

18 Years

45 Years

Both

Phase 1

United Kingdom

679

NCT01351480
(ClinicalTrials.gov)

June 2011

6/5/2011

Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes

Rheumatoid Arthritis

Biological: abatacept

Arthritis & Rheumatic Disease Specialties Research

Bristol-Myers Squibb

Completed

18 Years

N/A

All

Phase 3

United States

680

EUCTR2010-022378-15-DE
(EUCTR)

25/05/2011

09/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

EUCTR2010-022378-15-ES
(EUCTR)

19/05/2011

21/02/2011

A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

682

EUCTR2010-022224-77-BE
(EUCTR)

10/05/2011

14/01/2011

Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056

A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype

UCB Biosciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Belgium;United Kingdom

683

EUCTR2010-019871-31-CZ
(EUCTR)

10/05/2011

01/03/2011

Etoricoxib and placebo in patients with rheumatoid arthritis

A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou

Rheumatoid Arthritis (RA)
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

684

EUCTR2009-013758-33-NL
(EUCTR)

10/05/2011

16/09/2010

MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

685

EUCTR2009-015019-42-DE
(EUCTR)

10/05/2011

20/08/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

686

EUCTR2010-019871-31-SK
(EUCTR)

02/05/2011

28/02/2011

Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

687

NCT01329991
(ClinicalTrials.gov)

May 2011

4/4/2011

Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate

A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

Rheumatoid Arthritis

Drug: PLX5622;Drug: Placebo

Plexxikon

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

688

NCT01370902
(ClinicalTrials.gov)

May 2011

31/5/2011

Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC 0141-0000-0100;Drug: placebo

Innate Pharma

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany

689

NCT01262118
(ClinicalTrials.gov)

May 2011

15/11/2010

Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550 (tasocitinib)

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 1

United States;Hungary

690

EUCTR2010-022224-77-GB
(EUCTR)

27/04/2011

21/12/2010

Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056

Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype

UCB Biosciences Inc

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

691

EUCTR2010-023587-40-ES
(EUCTR)

13/04/2011

17/02/2011

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.

Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Finland;Germany;Netherlands;Spain;Italy;Greece;Sweden

692

EUCTR2010-022378-15-HU
(EUCTR)

08/04/2011

21/02/2011

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Czech Republic;Hungary;Spain;Germany;United Kingdom

693

EUCTR2010-021020-94-HU
(EUCTR)

08/04/2011

05/10/2010

A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a

active rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SAR153191
Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

694

EUCTR2010-023692-26-GB
(EUCTR)

07/04/2011

18/11/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany

695

EUCTR2009-015019-42-BE
(EUCTR)

04/04/2011

06/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 3

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

696

NCT01336218
(ClinicalTrials.gov)

April 2011

14/4/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Rheumatoid Arthritis;Healthy Volunteers

Drug: fostamatinib;Drug: rifampicin

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

697

EUCTR2010-021558-21-GB
(EUCTR)

28/03/2011

08/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine

698

EUCTR2010-021558-21-SK
(EUCTR)

23/03/2011

26/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine

699

EUCTR2010-023692-26-BG
(EUCTR)

17/03/2011

24/02/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

370

Phase 2B

Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany

700

EUCTR2010-022378-15-CZ
(EUCTR)

16/03/2011

21/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

701

EUCTR2010-021020-94-DE
(EUCTR)

10/03/2011

15/09/2010

active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

702

EUCTR2010-023469-22-NL
(EUCTR)

09/03/2011

02/12/2010

A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: ARA290
Product Code: ARA290

LUMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

703

EUCTR2010-022865-81-CZ
(EUCTR)

02/03/2011

22/12/2010

Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis

A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis

Product Name: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Hungary;Czech Republic

704

NCT01311622
(ClinicalTrials.gov)

March 2011

21/2/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects

An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects

Rheumatoid Arthritis;Healthy Subjects

Drug: warfarin;Drug: fostamatinib

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United Kingdom

705

NCT01353859
(ClinicalTrials.gov)

March 2011

13/5/2011

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Indonesia;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

NCT01284569
(ClinicalTrials.gov)

March 2011

21/1/2011

Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients

A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA

Rheumatoid Arthritis

Biological: ALX-0061;Biological: Placebo

Ablynx

NULL

Completed

18 Years

80 Years

All

Phase 1;Phase 2

Czechia;Hungary;Poland;Czech Republic;Netherlands

707

NCT01309854
(ClinicalTrials.gov)

March 2011

21/2/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects

An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Rheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in Blood

Drug: fostamatinib;Drug: pioglitazone

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

708

NCT01333878
(ClinicalTrials.gov)

March 2011

7/4/2011

Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage

An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray

Rheumatoid Arthritis

Biological: Subcutaneous Abatacept

Orrin M Troum, M.D. and Medical Associates

Bristol-Myers Squibb

Completed

18 Years

N/A

Both

Phase 2;Phase 3

United States

709

NCT01299961
(ClinicalTrials.gov)

March 2011

18/2/2011

Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: abatacept

University of California, Los Angeles

NULL

Completed

18 Years

N/A

All

Phase 3

United States

710

NCT01276262
(ClinicalTrials.gov)

March 2011

12/1/2011

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction

Drug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

45 Years

Female

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

711

NCT01296711
(ClinicalTrials.gov)

March 2011

14/2/2011

Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056

A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056

Rheumatoid Arthritis

Biological: CDP6038

UCB BIOSCIENCES, Inc.

NULL

Completed

18 Years

N/A

Both

190

Phase 2

United States;Belgium;United Kingdom

712

EUCTR2010-020890-18-CZ
(EUCTR)

25/02/2011

02/11/2010

AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

Product Name: Tofacitinib
Product Code: CP -690,550
INN or Proposed INN: tasocitinib citrate
Trade Name: Methotrexate Sodium Tablets 2.5 mg
INN or Proposed INN: Methotrexate Sodium

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic

713

EUCTR2010-020890-18-HU
(EUCTR)

18/02/2011

16/11/2010

Tofacitinib MRI in Early Rheumatoid Arthritis

AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF Tofacitinib (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

Product Name: Tofacitinib
Product Code: CP -690,550
INN or Proposed INN: tasocitinib citrate
Trade Name: Methotrexate Sodium Tablets 2.5 mg
INN or Proposed INN: Methotrexate Sodium

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary

714

EUCTR2010-020745-27-IT
(EUCTR)

18/02/2011

22/12/2010

Patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate, who have had an inadequate response to a single TNF-alfa antagonist.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Spain;Germany;United Kingdom;Italy

715

EUCTR2010-020744-35-IT
(EUCTR)

18/02/2011

22/12/2010

Patients with active Rheumatoid Arthritis despite current treatment with a DMARD.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

716

EUCTR2010-020892-22-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

717

EUCTR2010-020745-27-DE
(EUCTR)

17/02/2011

21/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

718

EUCTR2010-020744-35-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

719

EUCTR2010-023692-26-CZ
(EUCTR)

16/02/2011

22/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

720

EUCTR2009-012615-18-FR
(EUCTR)

16/02/2011

05/11/2010

Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION

Rheumatoid arthritis (RA)
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: UVEDOSE
INN or Proposed INN: COLECALCIFEROL

CHU de Clermont-Ferrand

NULL

Not Recruiting

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

721

EUCTR2010-021558-21-DE
(EUCTR)

15/02/2011

19/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Czech Republic;Hungary;Slovakia;Germany;United Kingdom

722

EUCTR2010-020743-12-DE
(EUCTR)

15/02/2011

21/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Chile;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

723

EUCTR2010-022865-81-HU
(EUCTR)

11/02/2011

15/02/2011

Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis

Product Name: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Czech Republic;Hungary

724

EUCTR2010-020892-22-IT
(EUCTR)

08/02/2011

22/12/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X

Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy

725

EUCTR2010-021558-21-HU
(EUCTR)

08/02/2011

07/10/2010

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Slovakia;Czech Republic;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

726

EUCTR2010-023692-26-HU
(EUCTR)

04/02/2011

08/02/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

727

NCT02092961
(ClinicalTrials.gov)

February 2011

19/3/2014

Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of Adalimumab

AstraZeneca

NULL

Terminated

18 Years

N/A

All

198

Phase 2

United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom

728

NCT01285752
(ClinicalTrials.gov)

February 2011

27/1/2011

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AK106-001616;Drug: Active comparator

Asahi Kasei Pharma Corporation

NULL

Completed

18 Years

65 Years

Both

240

Phase 2

Czech Republic;Germany;Hungary;Poland;Slovakia;Ukraine;United Kingdom

729

NCT01339481
(ClinicalTrials.gov)

February 2011

13/4/2011

A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

Rheumatoid Arthritis

Drug: abatacept

Astellas Pharma Inc

Perseid Therapeutics LLC

Completed

18 Years

N/A

Both

N/A

United States

730

NCT01292265
(ClinicalTrials.gov)

February 2011

7/2/2011

A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Terminated

18 Years

N/A

All

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

731

EUCTR2010-020892-22-BG
(EUCTR)

13/01/2011

09/11/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

732

EUCTR2010-020743-12-PL
(EUCTR)

11/01/2011

01/10/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

733

EUCTR2010-019871-31-BE
(EUCTR)

11/01/2011

31/08/2010

Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

734

NCT02586246
(ClinicalTrials.gov)

January 2011

23/10/2015

Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870

Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX)

Active Rheumatoid Arthritis

Drug: CDP870

Astellas Pharma Inc

UCB Japan Co. Ltd.

Completed

N/A

Both

Phase 3

Japan

735

NCT01382160
(ClinicalTrials.gov)

January 2011

2/12/2010

Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

Rheumatoid Arthritis

Biological: adalimumab

University Hospital, Tours

NULL

Completed

18 Years

N/A

Both

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

NCT01264770
(ClinicalTrials.gov)

January 2011

17/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fostamatinib and placebo injections;Drug: Adalimumab and placebo of fostamatinib;Drug: Placebo of fostamatinib, fostamatinib, and placebo injections

AstraZeneca

NULL

Terminated

18 Years

N/A

All

644

Phase 2

United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Ukraine;United Kingdom

737

NCT01411215
(ClinicalTrials.gov)

January 2011

13/5/2011

A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department

Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: Enbrel

Pfizer

NULL

Terminated

18 Years

N/A

All

160

N/A

China

738

NCT01242514
(ClinicalTrials.gov)

January 2011

10/11/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fostamatinib

AstraZeneca

NULL

Terminated

18 Years

N/A

All

1917

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Czech Republic;Estonia;France;Germany;Hungary;India;Israel;Italy;Latvia;Lithuania;Mexico;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Netherlands;Turkey

739

EUCTR2010-021558-21-CZ
(EUCTR)

23/12/2010

21/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom

740

EUCTR2010-019134-27-BG
(EUCTR)

23/12/2010

18/10/2010

A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY

Rhuematoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate 10 mg tablets
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folimet
Product Name: Folic Acid
INN or Proposed INN: Folic Acid

Chelsea Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

741

EUCTR2010-021020-94-ES
(EUCTR)

21/12/2010

21/10/2010

Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?

artritis reumatoide activa
MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Trade Name: SIMPONI 50 mg solución inyectable en pluma precargada
INN or Proposed INN: GOLIMUMAB
Other descriptive name: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

742

NCT02675803
(ClinicalTrials.gov)

December 20, 2010

9/7/2015

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients

A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: VAY736;Biological: VAY736 placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

Phase 1

Germany

743

EUCTR2010-020745-27-PT
(EUCTR)

17/12/2010

16/09/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom

744

EUCTR2010-020744-35-PT
(EUCTR)

17/12/2010

16/09/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom

745

EUCTR2010-020892-22-PT
(EUCTR)

17/12/2010

17/09/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Estonia;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

746

EUCTR2010-021020-94-CZ
(EUCTR)

17/12/2010

05/10/2010

active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Spain;Italy

747

EUCTR2010-020743-12-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Hungary;Germany;United Kingdom;Bulgaria;Estonia;France;Poland

748

EUCTR2010-020745-27-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Hungary;Portugal;Czech Republic;Germany;United Kingdom;France;Spain;Italy

749

EUCTR2010-020892-22-ES
(EUCTR)

13/12/2010

05/10/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom

750

EUCTR2010-020745-27-ES
(EUCTR)

13/12/2010

30/09/2010

A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

EUCTR2010-020744-35-ES
(EUCTR)

13/12/2010

23/09/2010

A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom

752

EUCTR2010-019871-31-GB
(EUCTR)

01/12/2010

08/10/2010

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

,NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

753

NCT01235598
(ClinicalTrials.gov)

December 2010

4/11/2010

Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Other: Placebo;Biological: Certolizumab Pegol (CZP) 200 mg;Biological: Certolizumab Pegol (CZP) 400 mg

UCB Pharma

NULL

Completed

18 Years

N/A

All

Phase 3

Denmark;Netherlands;Poland;Sweden

754

EUCTR2010-020743-12-BE
(EUCTR)

23/11/2010

07/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom

755

EUCTR2010-020892-22-BE
(EUCTR)

23/11/2010

01/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

756

EUCTR2010-020745-27-BE
(EUCTR)

23/11/2010

01/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

757

EUCTR2009-015019-42-FI
(EUCTR)

17/11/2010

27/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands

758

EUCTR2010-020743-12-BG
(EUCTR)

10/11/2010

09/11/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)

Rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

759

EUCTR2010-019871-31-AT
(EUCTR)

03/11/2010

01/09/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

760

EUCTR2010-019871-31-LT
(EUCTR)

02/11/2010

17/09/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2009-015019-42-LT
(EUCTR)

02/11/2010

17/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany

762

NCT01287858
(ClinicalTrials.gov)

November 2010

12/1/2011

Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects

Rheumatoid Arthritis

Drug: AC430

Daiichi Sankyo Inc.

NULL

Completed

18 Years

45 Years

Both

Phase 1

United States

763

NCT01217814
(ClinicalTrials.gov)

November 2010

7/10/2010

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers

A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-a Antagonists

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Placebo;Drug: Golimumab;Drug: methotrexate (MTX);Drug: Folic/folinic acid

Sanofi

Regeneron Pharmaceuticals

Terminated

18 Years

75 Years

All

Phase 2

United States;Colombia;Czechia;Italy;Mexico;Spain;Brazil;Canada;Czech Republic;Germany;Hungary;Norway

764

NCT01245790
(ClinicalTrials.gov)

November 2010

19/11/2010

A Study of Fostamatinib in Subjects With Impaired Kidney Function

An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg

Rheumatoid Arthritis;Renal Impairment

Drug: fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

765

NCT01255761
(ClinicalTrials.gov)

November 2010

6/12/2010

A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia

Rheumatoid Arthritis

Biological: Certolizumab Pegol (CZP)

UCB Pharma

NULL

Completed

18 Years

N/A

All

736

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

766

EUCTR2010-020744-35-GB
(EUCTR)

26/10/2010

05/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

767

EUCTR2010-020745-27-GB
(EUCTR)

26/10/2010

05/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;United States;Spain;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

768

EUCTR2010-020743-12-GB
(EUCTR)

26/10/2010

05/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom

769

EUCTR2010-020892-22-GB
(EUCTR)

26/10/2010

05/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

770

EUCTR2010-019871-31-DE
(EUCTR)

25/10/2010

09/12/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

771

EUCTR2010-020744-35-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

772

EUCTR2010-020892-22-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

United States;Portugal;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Peru;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany

773

EUCTR2010-019134-27-CZ
(EUCTR)

19/10/2010

28/06/2010

Rhuematoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folic Acid
Product Name: Folic Acid
INN or Proposed INN: Folic Acid

Chelsea Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Czech Republic;Bulgaria

774

EUCTR2010-019871-31-FI
(EUCTR)

18/10/2010

30/08/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

775

EUCTR2010-021020-94-IT
(EUCTR)

15/10/2010

28/09/2010

A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND

active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Code: SAR153191
Trade Name: SIMPONI
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & D?veloppement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

776

EUCTR2010-020892-22-HU
(EUCTR)

15/10/2010

11/08/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;Italy;United Kingdom

777

EUCTR2010-020743-12-HU
(EUCTR)

14/10/2010

11/08/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Poland;Bulgaria;Germany;United Kingdom

778

EUCTR2008-001523-57-DE
(EUCTR)

14/10/2010

10/06/2010

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;United Kingdom;Germany;Denmark;France;Norway;Spain;Italy

779

EUCTR2010-020744-35-LT
(EUCTR)

11/10/2010

18/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

780

EUCTR2010-020892-22-LT
(EUCTR)

11/10/2010

18/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

781

EUCTR2010-020892-22-CZ
(EUCTR)

11/10/2010

30/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

782

EUCTR2010-020743-12-SK
(EUCTR)

11/10/2010

05/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

783

EUCTR2010-020745-27-CZ
(EUCTR)

11/10/2010

30/08/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

784

EUCTR2010-020744-35-CZ
(EUCTR)

11/10/2010

30/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

785

EUCTR2010-020892-22-SK
(EUCTR)

11/10/2010

05/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

786

EUCTR2009-015019-42-AT
(EUCTR)

05/10/2010

01/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany

787

EUCTR2009-016119-38-BG
(EUCTR)

05/10/2010

18/08/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

788

NCT01164579
(ClinicalTrials.gov)

October 2010

15/7/2010

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

109

Phase 2

United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico

789

EUCTR2010-020892-22-EE
(EUCTR)

27/09/2010

16/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

790

NCT01208181
(ClinicalTrials.gov)

September 27, 2010

22/9/2010

A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Etoricoxib 60 mg;Drug: Etoricoxib 90 mg;Drug: Placebo to Etoricoxib 60 mg;Drug: Placebo to Etoricoxib 90 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

1404

Phase 3

Argentina;Austria;Canada;Colombia;Czech Republic;Finland;Germany;Guatemala;India;Lithuania;Mexico;Panama;Peru;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

791

EUCTR2010-020743-12-EE
(EUCTR)

24/09/2010

16/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

Astra Zeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany

792

EUCTR2009-013758-33-DK
(EUCTR)

09/09/2010

09/06/2010

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

793

NCT01162421
(ClinicalTrials.gov)

September 2010

25/5/2010

A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

Radiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: adalimumab;Drug: Methotrexate

AbbVie (prior sponsor, Abbott)

Mount Sinai Hospital, Canada

Completed

18 Years

99 Years

All

Phase 4

Canada

794

NCT01197534
(ClinicalTrials.gov)

September 2010

8/9/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo, fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

All

913

Phase 3

United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom

795

NCT01116141
(ClinicalTrials.gov)

September 2010

3/5/2010

A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy

Rheumatoid Arthritis

Drug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic Acid

Chelsea Therapeutics

NULL

Completed

18 Years

80 Years

Both

250

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

796

NCT01197521
(ClinicalTrials.gov)

September 2010

8/9/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo, fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

All

923

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;Estonia;France;Hungary;India;Mexico;Peru;Poland;Slovakia;Ukraine;United Kingdom;Germany;Russian Federation

797

NCT01197755
(ClinicalTrials.gov)

September 2010

8/9/2010

(OSKIRA-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

323

Phase 3

United States;Argentina;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Mexico;Portugal;South Africa;Spain;United Kingdom;Australia

798

NCT01213017
(ClinicalTrials.gov)

September 2010

29/9/2010

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: certolizumab pegol

Oklahoma Medical Research Foundation

UCB Pharma

Completed

18 Years

N/A

All

Phase 3

United States

799

EUCTR2009-016119-38-LV
(EUCTR)

13/08/2010

28/05/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

800

NCT01181050
(ClinicalTrials.gov)

August 2010

12/8/2010

Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0142-0002;Drug: placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

75 Years

All

Phase 2

Germany;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

801

EUCTR2010-019261-28-DE
(EUCTR)

26/07/2010

16/06/2010

A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: NNC 0142-0000-0002
Product Code: NNC 142-0002

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

160

Germany

802

EUCTR2009-012759-12-CZ
(EUCTR)

16/07/2010

22/02/2010

A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Phase 3

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden

803

EUCTR2009-017051-10-NL
(EUCTR)

13/07/2010

25/05/2010

Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis

Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.
MedDRA version: 12.0;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Trade Name: Dexamethason
Product Name: dexamethason

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

804

EUCTR2009-012041-35-BE
(EUCTR)

02/07/2010

30/09/2009

A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Other descriptive name: N.A.

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria

805

JPRN-UMIN000003807

2010/07/01

01/07/2010

A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis

Rheumatoid Arthritis

Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate

Japan Association of Rheumatologists in Private Practice

NULL

Complete: follow-up complete

Not applicable

Male and Female

160

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

806

EUCTR2009-016119-38-CZ
(EUCTR)

01/07/2010

02/07/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

Czech Republic;Poland;Bulgaria;Latvia;United Kingdom

807

NCT01593332
(ClinicalTrials.gov)

July 2010

7/1/2012

Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

DMARD Resistant Rheumatoid Arthritis

Drug: Rituximab

Mashhad University of Medical Sciences

Roche Pharma AG

Completed

19 Years

75 Years

Both

Phase 4

Iran, Islamic Republic of

808

EUCTR2009-016119-38-PL
(EUCTR)

23/06/2010

30/04/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

809

EUCTR2009-013758-33-SE
(EUCTR)

17/06/2010

22/03/2010

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

810

EUCTR2009-012759-12-GR
(EUCTR)

15/06/2010

13/11/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

EUCTR2009-010582-23-GR
(EUCTR)

15/06/2010

30/12/2009

A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal
Product Name: Golimumab prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

812

EUCTR2008-001523-57-HU
(EUCTR)

14/06/2010

27/04/2010

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

813

EUCTR2010-019873-13-BE
(EUCTR)

07/06/2010

14/04/2010

Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA

early rheumatoid arthritis
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: RoActemra
Product Name: Tocilizumab

UCL Cliniques Universitaires Saint Luc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium

814

EUCTR2008-007185-33-NL
(EUCTR)

20/05/2010

28/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

815

EUCTR2009-016119-38-GB
(EUCTR)

19/05/2010

17/03/2010

Safety and Efficacy of AMG 827 in Subjects With RA

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

816

EUCTR2009-014735-20-BG
(EUCTR)

18/05/2010

23/02/2010

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Latvia

817

EUCTR2009-015950-39-DE
(EUCTR)

12/05/2010

28/12/2009

Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis

Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA

Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera ®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Johann Wolfgang Goethe-Universität Frankfurt/M.

NULL

Not Recruiting

Female: yes
Male: yes

Germany

818

NCT01059448
(ClinicalTrials.gov)

May 2010

28/1/2010

Safety and Efficacy of AMG 827 in Subjects With RA

A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 827

Amgen

NULL

Terminated

N/A

Both

211

Phase 2

United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom

819

EUCTR2008-002623-85-SE
(EUCTR)

28/04/2010

04/03/2010

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium Tablets 2.5mg
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Spain;Ireland;Italy;Sweden

820

EUCTR2009-017379-90-IT
(EUCTR)

27/04/2010

31/03/2010

Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND

RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

INN or Proposed INN: ETANERCEPT

AZIENDA OSPEDALIERA SENESE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

EUCTR2009-014735-20-CZ
(EUCTR)

23/04/2010

12/11/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan

822

EUCTR2009-012118-27-BE
(EUCTR)

13/04/2010

23/02/2010

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 -AEK - Over Encapsulated Tablet - 50 mg
Product Code: JNJ-38518168
INN or Proposed INN: N/A

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;Spain;Belgium;Netherlands;United Kingdom

823

EUCTR2009-011137-26-PL
(EUCTR)

01/04/2010

25/01/2010

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland

824

EUCTR2009-015636-15-HU
(EUCTR)

25/03/2010

08/02/2010

Rheumatoid arthritis

An Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa

825

EUCTR2009-014735-20-PL
(EUCTR)

23/03/2010

21/12/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

826

EUCTR2009-011137-26-GR
(EUCTR)

22/03/2010

20/10/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

827

EUCTR2009-012759-12-HU
(EUCTR)

17/03/2010

25/01/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

828

EUCTR2009-010582-23-IT
(EUCTR)

10/03/2010

08/01/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

829

EUCTR2009-011137-26-PT
(EUCTR)

01/03/2010

09/12/2009

Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

830

NCT01610791
(ClinicalTrials.gov)

March 2010

31/5/2012

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

121

Phase 3

Morocco

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

831

NCT01034397
(ClinicalTrials.gov)

March 2010

16/12/2009

A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Portugal

832

NCT01197066
(ClinicalTrials.gov)

March 2010

17/3/2010

Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

A Phase ? Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

Rheumatoid Arthritis

Drug: Certolizumab Pegol

Korea Otsuka Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

N/A

All

110

Phase 3

Korea, Republic of

833

NCT01063062
(ClinicalTrials.gov)

February 28, 2010

3/2/2010

A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

107

Phase 3

Egypt

834

EUCTR2009-011137-26-CZ
(EUCTR)

26/02/2010

13/10/2009

Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

835

EUCTR2009-011137-26-AT
(EUCTR)

25/02/2010

04/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

836

EUCTR2009-016789-10-NL
(EUCTR)

19/02/2010

17/11/2009

Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab

To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy

Trade Name: Focetria
Trade Name: Pandemrix,

Div KIR AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

837

EUCTR2009-014735-20-LT
(EUCTR)

18/02/2010

25/11/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

838

EUCTR2009-011137-26-IT
(EUCTR)

15/02/2010

02/10/2009

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE

Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: Golimumab
Product Code: SCH900259
Product Name: Golimumab
Product Code: SCH 900259

Shering Plough Research Institute, A division of Schering Plough Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

839

EUCTR2009-010582-23-BE
(EUCTR)

10/02/2010

23/09/2009

Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

840

EUCTR2008-007185-33-BE
(EUCTR)

01/02/2010

10/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

841

NCT01063803
(ClinicalTrials.gov)

February 2010

2/2/2010

Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ATN-103

Ablynx

NULL

Completed

18 Years

80 Years

Both

266

Phase 2

United States;Canada;Hungary;Japan;Russian Federation;Serbia;South Africa;Switzerland

842

EUCTR2009-012759-12-IE
(EUCTR)

26/01/2010

05/11/2009

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

843

EUCTR2009-014735-20-HU
(EUCTR)

25/01/2010

02/11/2009

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

216

Phase 2

Czech Republic;Estonia;Hungary;Poland;Lithuania;Bulgaria

844

NCT01754805
(ClinicalTrials.gov)

January 22, 2010

19/12/2012

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: peficitinib;Drug: methotrexate

Astellas Pharma Inc

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

845

EUCTR2009-011137-26-BE
(EUCTR)

18/01/2010

19/10/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

846

EUCTR2009-012759-12-PT
(EUCTR)

12/01/2010

21/10/2009

A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden

847

EUCTR2009-012759-12-SE
(EUCTR)

12/01/2010

17/11/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

848

EUCTR2008-007185-33-DE
(EUCTR)

12/01/2010

02/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

849

NCT01050998
(ClinicalTrials.gov)

January 5, 2010

15/1/2010

A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Mavrilimumab 10 mg;Biological: Mavrilimumab 30 mg;Biological: Mavrilimumab 50 mg;Biological: Mavrilimumab 100 mg;Other: Placebo

MedImmune LLC

MedImmune Ltd

Completed

18 Years

80 Years

All

516

Phase 2

Bulgaria;Czechia;Estonia;Hungary;Japan;Latvia;Lithuania;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Serbia

850

EUCTR2009-010582-23-DE
(EUCTR)

04/01/2010

22/09/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

851

NCT01034137
(ClinicalTrials.gov)

January 2010

16/12/2009

A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

317

Phase 3

Netherlands

852

NCT01089023
(ClinicalTrials.gov)

January 2010

8/3/2010

A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates

853

EUCTR2009-010582-23-GB
(EUCTR)

31/12/2009

28/06/2010

Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden

854

EUCTR2009-014735-20-EE
(EUCTR)

29/12/2009

27/10/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Czech Republic;Estonia;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan

855

EUCTR2009-014735-20-LV
(EUCTR)

29/12/2009

21/10/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

EUCTR2009-011137-26-IE
(EUCTR)

21/12/2009

15/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

857

EUCTR2009-012759-12-FI
(EUCTR)

21/12/2009

28/09/2009

A 2 year, global, randomized, phase III clinical trial stuying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with methotrexate and methotrexate only, in patients with early, moderate to severe rheumatoid arthritis.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden

858

EUCTR2009-010582-23-SE
(EUCTR)

16/12/2009

23/10/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

859

EUCTR2008-002623-85-DE
(EUCTR)

16/12/2009

12/06/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel ®
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Enbrel ®
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium Tablets 2.5mg
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

300

Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France

860

EUCTR2009-011137-26-FR
(EUCTR)

15/12/2009

10/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

861

EUCTR2009-011137-26-DK
(EUCTR)

07/12/2009

02/11/2009

Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland

862

EUCTR2009-012759-12-DK
(EUCTR)

07/12/2009

03/11/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Denmark;Australia;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden

863

EUCTR2009-011137-26-NL
(EUCTR)

02/12/2009

31/08/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

864

EUCTR2009-012759-12-ES
(EUCTR)

01/12/2009

23/09/2009

Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Artritis ReumatoideRheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

865

NCT01004432
(ClinicalTrials.gov)

December 2009

29/10/2009

Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

Arthritis;Arthritis, Rheumatoid;Autoimmune Diseases

Drug: Golimumab 50 mg SC;Drug: Golimumab 2 mg/kg IV;Drug: Methotrexate (MTX);Drug: Placebo SC;Drug: Placebo IV

Janssen Biotech, Inc.

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

433

Phase 3

United States;Austria;Belgium;Canada;Germany;Greece;Sweden;United Kingdom;France;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

866

NCT01001832
(ClinicalTrials.gov)

December 2009

26/10/2009

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abatacept

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

All

118

Phase 2;Phase 3

Japan

867

EUCTR2009-010582-23-AT
(EUCTR)

26/11/2009

12/10/2009

Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

868

EUCTR2008-007185-33-GB
(EUCTR)

26/11/2009

28/07/2010

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;Germany;United Kingdom;Netherlands;Belgium

869

EUCTR2009-012759-12-FR
(EUCTR)

13/11/2009

09/10/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

870

EUCTR2009-012759-12-DE
(EUCTR)

13/11/2009

25/08/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

871

EUCTR2009-012759-12-IT
(EUCTR)

12/11/2009

17/11/2009

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: Methotrexate ``Lederle`` 2.5mg tablets
INN or Proposed INN: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

872

EUCTR2009-011137-26-SK
(EUCTR)

11/11/2009

19/11/2009

Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

873

EUCTR2008-002623-85-IE
(EUCTR)

06/11/2009

15/09/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

300

Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden

874

EUCTR2007-003288-36-GB
(EUCTR)

04/11/2009

03/10/2008

A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom

875

NCT00976599
(ClinicalTrials.gov)

November 2009

11/9/2009

A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550 + methotrexate;Drug: Placebo + Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

876

NCT01007175
(ClinicalTrials.gov)

November 2009

2/11/2009

Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

Rheumatoid Arthritis

Biological: ATN-103 10 mg q4wks;Biological: ATN-103 30 mg q4wks;Biological: ATN-103 80 mg q4wks;Biological: ATN-103 10 mg q8wks;Biological: ATN-103 80 mg q8wks

Ablynx

NULL

Completed

20 Years

75 Years

Both

Phase 1;Phase 2

Japan

877

NCT01007435
(ClinicalTrials.gov)

October 31, 2009

3/11/2009

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Placebo to tocilizumab;Drug: Methotrexate;Drug: Placebo to methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1162

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;China;Colombia;Denmark;Finland;France;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;New Zealand;Panama;Peru;Philippines;Poland;Portugal;Puerto Rico;Russian Federation;Singapore;South Africa;Spain;Sweden;Thailand;Turkey;United Kingdom;Czech Republic

878

EUCTR2009-012118-27-NL
(EUCTR)

27/10/2009

27/05/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

879

EUCTR2009-011137-26-ES
(EUCTR)

23/10/2009

06/08/2009

Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE

Artritis reumatoide
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

880

EUCTR2009-011137-26-FI
(EUCTR)

22/10/2009

25/08/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

881

EUCTR2009-011137-26-GB
(EUCTR)

19/10/2009

18/10/2010

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

882

EUCTR2009-011137-26-HU
(EUCTR)

19/10/2009

02/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

883

EUCTR2009-012705-19-CZ
(EUCTR)

16/10/2009

17/07/2009

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Czech Republic;Bulgaria

884

EUCTR2008-007185-33-HU
(EUCTR)

16/10/2009

09/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

885

EUCTR2009-012759-12-GB
(EUCTR)

14/10/2009

17/08/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

886

EUCTR2009-012218-30-PT
(EUCTR)

06/10/2009

12/08/2009

A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT

Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.

Trade Name: RoActemra

Roche Farmacêutica Química, Lda.

NULL

Not Recruiting

Female: yes
Male: yes

Portugal

887

EUCTR2009-011137-26-DE
(EUCTR)

05/10/2009

03/08/2009

Active Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

888

EUCTR2008-002623-85-GB
(EUCTR)

01/10/2009

17/08/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA). (Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Wyeth Pharmaceuticals Inc. Philadelphia (A Pfizer Company)

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Qatar;Spain;Ireland;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Romania;Germany;Netherlands;Sweden

889

NCT00993317
(ClinicalTrials.gov)

October 2009

9/10/2009

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo of CDP870;Drug: CDP870 200mg;Drug: Methotrexate

Korea Otsuka Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

75 Years

All

127

Phase 3

Korea, Republic of

890

EUCTR2009-012705-19-BG
(EUCTR)

29/09/2009

06/10/2009

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

104

Phase 2

Hungary;Czech Republic;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

EUCTR2009-012118-27-ES
(EUCTR)

28/09/2009

03/07/2009

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.JNJ-38518168 se está desarrollando para el tratamiento de la Artritis Reumatoide
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

892

EUCTR2006-006373-25-FI
(EUCTR)

21/09/2009

16/06/2009

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

893

EUCTR2009-012759-12-AT
(EUCTR)

14/09/2009

21/08/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

894

EUCTR2008-001847-20-DE
(EUCTR)

08/09/2009

03/06/2009

Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate

Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden

895

EUCTR2009-012118-27-CZ
(EUCTR)

04/09/2009

25/06/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

United Kingdom;Czech Republic;Netherlands;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

896

EUCTR2009-012118-27-GB
(EUCTR)

04/09/2009

18/06/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

897

EUCTR2006-006373-25-GB
(EUCTR)

03/09/2009

16/11/2010

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2;Phase 3

Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

898

NCT00975130
(ClinicalTrials.gov)

September 2009

20/8/2009

Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Arthritis, Rheumatoid

Biological: SC golimumab;Biological: IV golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

3366

Phase 3

Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom

899

NCT00993668
(ClinicalTrials.gov)

September 2009

9/10/2009

Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo

Rheumatoid Arthritis

Other: Placebo;Biological: Certolizumab pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

224

Phase 4

United States

900

NCT00959036
(ClinicalTrials.gov)

September 2009

13/8/2009

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

Active Rheumatoid Arthritis

Drug: ATN-103;Drug: Placebo;Drug: Methotrexate

Ablynx

NULL

Completed

18 Years

80 Years

Both

252

Phase 1;Phase 2

United States;Belgium;Canada;Germany;Hungary;Russian Federation;Serbia;South Africa;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

901

NCT00969527
(ClinicalTrials.gov)

September 2009

27/8/2009

Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Oncoxin + Viusid;Dietary Supplement: Placebo

Catalysis SL

NULL

Completed

18 Years

N/A

Both

Phase 3

Cuba

902

EUCTR2008-002623-85-FR
(EUCTR)

18/08/2009

04/06/2009

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium tablets 2.5mg
Product Name: Methotrexate
INN or Proposed INN: methotrexate

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Spain;Ireland;Italy;Sweden

903

EUCTR2009-012705-19-HU
(EUCTR)

17/08/2009

16/07/2009

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

104

Phase 2

Hungary;Czech Republic;Bulgaria

904

EUCTR2008-008338-35-FI
(EUCTR)

13/08/2009

14/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

905

NCT01224041
(ClinicalTrials.gov)

August 2009

18/10/2010

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

18 Years

75 Years

Both

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

906

EUCTR2008-006075-75-CZ
(EUCTR)

29/07/2009

28/07/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;United Kingdom;Germany;Czech Republic

907

EUCTR2008-002623-85-ES
(EUCTR)

27/07/2009

19/02/2010

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Ireland;Spain;Italy;Sweden

908

EUCTR2008-002623-85-NL
(EUCTR)

27/07/2009

01/05/2009

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Trade Name: Enbrel 25mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Enbrel 50mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden

909

EUCTR2008-008338-35-DE
(EUCTR)

14/07/2009

04/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain

910

EUCTR2008-007788-17-DE
(EUCTR)

24/06/2009

08/04/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Czech Republic;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

EUCTR2008-008338-35-ES
(EUCTR)

19/06/2009

27/03/2009

PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato

CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

Pfizer, S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

912

EUCTR2008-008338-35-BG
(EUCTR)

16/06/2009

22/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

913

EUCTR2008-007023-26-BG
(EUCTR)

16/06/2009

22/05/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Poland;Bulgaria

914

EUCTR2008-008338-35-GB
(EUCTR)

11/06/2009

09/04/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain

915

EUCTR2008-008338-35-DK
(EUCTR)

03/06/2009

29/04/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

916

EUCTR2008-007023-26-PL
(EUCTR)

03/06/2009

05/06/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Bulgaria;Poland

917

EUCTR2008-007788-17-BG
(EUCTR)

01/06/2009

22/05/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Germany;Czech Republic;Bulgaria

918

NCT00947492
(ClinicalTrials.gov)

June 2009

27/7/2009

Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs

Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).

Rheumatoid Arthritis

Biological: Venous blood sample

Assistance Publique Hopitaux De Marseille

NULL

Active, not recruiting

18 Years

N/A

Both

N/A

France

919

EUCTR2008-008338-35-SK
(EUCTR)

25/05/2009

09/09/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

920

EUCTR2008-007788-17-CZ
(EUCTR)

20/05/2009

18/03/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Germany;Czech Republic;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

921

EUCTR2008-008338-35-CZ
(EUCTR)

20/05/2009

18/03/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

922

EUCTR2008-007023-26-CZ
(EUCTR)

18/05/2009

10/03/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Bulgaria;Poland

923

NCT00902369
(ClinicalTrials.gov)

May 2009

14/5/2009

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AK106-001616;Drug: Placebo;Drug: Active comparator

Asahi Kasei Pharma Corporation

NULL

Completed

18 Years

65 Years

Both

130

Phase 2

Czech Republic;Germany;Hungary;Lithuania;Romania;United Kingdom

924

NCT00920608
(ClinicalTrials.gov)

May 2009

12/6/2009

A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AZD9056;Drug: Methotrexate

AstraZeneca

NULL

Withdrawn

18 Years

70 Years

Both

Phase 1

NULL

925

EUCTR2008-007023-26-GR
(EUCTR)

29/04/2009

03/04/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Greece;Poland;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

926

EUCTR2008-006075-75-DE
(EUCTR)

22/04/2009

17/02/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;United Kingdom;Germany

927

EUCTR2008-006075-75-GB
(EUCTR)

14/04/2009

28/04/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;Germany;United Kingdom

928

EUCTR2009-011044-20-GB
(EUCTR)

08/04/2009

14/04/2009

A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Code: AZD5672
Trade Name: Avelox®
Product Name: Avelox- Moxifloxacin

AstraZeneca AB

NULL

Not Recruiting

Female: no
Male: yes

United Kingdom

929

NCT00887770
(ClinicalTrials.gov)

April 2009

23/4/2009

A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart

A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Rheumatoid Arthritis

Drug: AZD5672;Drug: Moxifloxacin;Drug: placebo

AstraZeneca

Quintiles Limited

Completed

18 Years

45 Years

Male

Phase 1

United Kingdom

930

EUCTR2008-003011-12-GB
(EUCTR)

30/03/2009

27/04/2009

Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA

Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

EUCTR2008-006075-75-HU
(EUCTR)

24/03/2009

18/02/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;United Kingdom;Germany

932

EUCTR2008-000744-13-BG
(EUCTR)

19/03/2009

26/01/2009

Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy

933

NCT00850343
(ClinicalTrials.gov)

March 2009

23/2/2009

Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)

Rheumatoid Arthritis

Drug: Certolizumab pegol

Astellas Pharma Inc

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

208

Phase 3

Japan

934

NCT00871767
(ClinicalTrials.gov)

March 2009

26/3/2009

AZD5672 Bioavailability Study in Healthy Male and Female Subjects

An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects

Rheumatoid Arthritis

Drug: AZD5672

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United Kingdom

935

NCT00851318
(ClinicalTrials.gov)

March 2009

23/2/2009

Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)

Rheumatoid Arthritis

Drug: Certolizumab pegol;Drug: Methotrexate

Astellas Pharma Inc

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

285

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

EUCTR2008-001523-57-ES
(EUCTR)

09/02/2009

22/10/2008

Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

937

EUCTR2008-001847-20-SE
(EUCTR)

02/02/2009

23/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

938

NCT00754572
(ClinicalTrials.gov)

February 2009

17/9/2008

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

418

Phase 3

Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela

939

NCT00851240
(ClinicalTrials.gov)

February 2009

2/2/2009

BTT-1023 in Rheumatoid Arthritis

A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Rheumatoid Arthritis

Drug: BTT-1023;Drug: Placebo

Biotie Therapies Corp.

NULL

Completed

18 Years

75 Years

Both

Phase 1

Bulgaria

940

EUCTR2007-003288-36-ES
(EUCTR)

08/01/2009

09/03/2010

Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

941

EUCTR2008-001523-57-DK
(EUCTR)

07/01/2009

14/10/2008

Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom

942

EUCTR2008-007225-39-BE
(EUCTR)

06/01/2009

12/02/2009

A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.

A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA

early active Rheumatoid Arthritis, previously untreated with DMARDS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Ledertrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Salazopyrine
INN or Proposed INN: SULFASALAZINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE

University Hospitals Leuven

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 4

Belgium

943

EUCTR2008-001523-57-GB
(EUCTR)

06/01/2009

22/10/2008

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom

944

NCT02405234
(ClinicalTrials.gov)

January 2009

4/11/2014

Ascension PyroCarbon Radial Head Study

Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head

Degenerative Arthritis;Radial Head Fracture;Rheumatoid Arthritis

Device: Carbon Modular Radial Head replacement;Device: Metal Radial Head replacement

Integra LifeSciences Corporation

NULL

Terminated

18 Years

85 Years

All

N/A

United States

945

NCT00838058
(ClinicalTrials.gov)

January 2009

2/2/2009

A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.

An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers

Rheumatoid Arthritis;Healthy Volunteers

Drug: CE-224,535;Drug: CE 224,535

Pfizer

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

946

NCT00825409
(ClinicalTrials.gov)

January 2009

16/1/2009

Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head

Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head to Treat Arthritis, Fractures of the Radial Head, Relief of Symptoms After Radial Head Resection, or Revision of a Failed Radial Head Implant.

Degenerative Arthritis;Post-Traumatic Arthritis;Rheumatoid Arthritis

Device: Carbon Modular Radial Head;Device: Metal Radial Head

Ascension Orthopedics, Inc.

NULL

Recruiting

18 Years

85 Years

Both

203

N/A

United States

947

NCT00848120
(ClinicalTrials.gov)

December 31, 2008

19/2/2009

A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Philippines

948

EUCTR2008-001523-57-IT
(EUCTR)

23/12/2008

17/03/2009

active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

949

EUCTR2008-001847-20-LV
(EUCTR)

19/12/2008

29/12/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden

950

EUCTR2008-001847-20-DK
(EUCTR)

10/12/2008

21/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

951

EUCTR2008-000744-13-BE
(EUCTR)

09/12/2008

08/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 2

France;Belgium;Bulgaria;Germany;Italy

952

EUCTR2007-003288-36-FR
(EUCTR)

08/12/2008

21/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

953

EUCTR2008-004931-39-PL
(EUCTR)

08/12/2008

04/11/2008

A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.

Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ALD518
Product Code: ALD518
Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb)

Alder Biopharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

120

Poland

954

NCT01011959
(ClinicalTrials.gov)

December 2008

10/11/2009

A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Rheumatoid Arthritis

Biological: REGN88

Regeneron Pharmaceuticals

Sanofi

Completed

18 Years

N/A

Both

Phase 1

United States

955

NCT00767325
(ClinicalTrials.gov)

December 2008

6/10/2008

A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

104

Phase 3

Denmark;France;Germany;Hungary;Italy;Norway;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

NCT00815906
(ClinicalTrials.gov)

December 2008

18/12/2008

Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: SBI-087

Pfizer

Emergent Product Development Seattle LLC

Completed

20 Years

70 Years

Both

Phase 1

Japan

957

EUCTR2007-003288-36-FI
(EUCTR)

28/11/2008

30/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

958

EUCTR2008-006256-22-FR
(EUCTR)

21/11/2008

31/10/2008

Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.

rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: remicade
INN or Proposed INN: infliximab
Trade Name: humira
INN or Proposed INN: adalimumab
Trade Name: enbrel
INN or Proposed INN: etanercept

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

959

EUCTR2007-003288-36-DE
(EUCTR)

10/11/2008

03/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

960

EUCTR2008-001523-57-FR
(EUCTR)

04/11/2008

21/10/2008

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;Norway;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

961

NCT00771030
(ClinicalTrials.gov)

November 2008

9/10/2008

Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 827;Other: Placebo

Amgen

NULL

Completed

18 Years

70 Years

Both

Phase 1;Phase 2

Canada;Mexico;United States

962

NCT00791999
(ClinicalTrials.gov)

November 2008

14/11/2008

Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.

Rheumatoid Arthritis

Drug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870

Otsuka Pharmaceutical Co., Ltd.

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

316

Phase 2;Phase 3

Japan

963

NCT00791921
(ClinicalTrials.gov)

November 2008

14/11/2008

Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

Rheumatoid Arthritis

Drug: CDP870;Drug: Placebo of CDP870

Otsuka Pharmaceutical Co., Ltd.

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

230

Phase 3

Japan

964

EUCTR2007-003288-36-NL
(EUCTR)

15/10/2008

11/07/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

965

EUCTR2007-003288-36-AT
(EUCTR)

01/10/2008

18/08/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

966

NCT00867516
(ClinicalTrials.gov)

October 2008

20/3/2009

Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis

A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Biological: ALD518;Biological: Infusion without ALD518'

CSL Behring

NULL

Completed

18 Years

80 Years

All

127

Phase 2

Canada;Georgia;India;Poland;Russian Federation;Serbia

967

NCT00771420
(ClinicalTrials.gov)

October 2008

10/10/2008

A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis

A Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: CAM-3001;Other: Placebo

MedImmune Ltd

NULL

Completed

18 Years

70 Years

Both

Phase 1

Germany

968

NCT00780793
(ClinicalTrials.gov)

September 2008

27/10/2008

Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study

Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity

Rheumatoid Arthritis

Drug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenance

Assistance Publique - Hôpitaux de Paris

French Society of Rheumatology

Completed

18 Years

N/A

Both

250

Phase 4

France

969

EUCTR2007-001585-33-DE
(EUCTR)

19/08/2008

14/04/2008

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany

970

EUCTR2007-007539-14-HU
(EUCTR)

15/08/2008

26/08/2008

A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD5672
Product Code: AZD5672
Other descriptive name: AZD5672
Product Name: AZD5672
Product Code: AZD5672
Other descriptive name: AZD5672
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

971

EUCTR2007-007539-14-BG
(EUCTR)

14/08/2008

06/08/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

972

EUCTR2007-007539-14-PL
(EUCTR)

05/08/2008

30/06/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

973

EUCTR2006-006373-25-BG
(EUCTR)

04/08/2008

14/09/2009

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

974

NCT00805467
(ClinicalTrials.gov)

August 2008

5/12/2008

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis

Drug: Fostamatinib Disodium (R935788)

AstraZeneca

NULL

Terminated

18 Years

N/A

All

624

Phase 2

United States;Belgium;Bulgaria;Colombia;France;Germany;Italy;Mexico;Peru;Poland;Romania

975

NCT00754559
(ClinicalTrials.gov)

August 2008

17/9/2008

A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.

Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

286

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

976

NCT00718588
(ClinicalTrials.gov)

July 2008

16/7/2008

A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MTRX1011A

Genentech, Inc.

NULL

Terminated

18 Years

80 Years

Both

Phase 1

United States

977

NCT00713544
(ClinicalTrials.gov)

July 2008

9/7/2008

A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis

A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

Rheumatoid Arthritis

Drug: AZD5672;Drug: Etanercept;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

373

Phase 2

Bulgaria;Colombia;Czech Republic;Hungary;Italy;Latvia;Malta;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;Argentina;Netherlands;Peru

978

NCT00714493
(ClinicalTrials.gov)

July 2008

10/7/2008

RESTART C0168Z05 Rheumatoid Arthritis Study

A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

Rheumatoid Arthritis

Biological: Infliximab

Centocor Ortho Biotech Services, L.L.C.

Schering-Plough

Completed

18 Years

N/A

All

203

Phase 4

United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium

979

NCT01055899
(ClinicalTrials.gov)

July 2008

25/1/2010

Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

Rheumatoid Arthritis

Biological: REGN88

Regeneron Pharmaceuticals

Sanofi

Completed

18 Years

N/A

Both

Phase 1

United States

980

EUCTR2007-007539-14-IT
(EUCTR)

17/06/2008

06/06/2008

Male and female patients over 18 years of age, with active RA despite current treatment with methotrexate. All patients will continue with background methotrexate therapy.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD5672
Product Code: AZD5672
Product Name: AZD5672
Product Code: AZD5672
INN or Proposed INN: ETANERCEPT

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

981

EUCTR2007-007539-14-CZ
(EUCTR)

12/06/2008

18/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

982

EUCTR2007-005464-26-GB
(EUCTR)

05/06/2008

11/04/2008

Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.

The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II

Rheumatoid Arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Kings College London

Guys and St Thomas'NHS Foundation Trust

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United Kingdom

983

EUCTR2007-000886-40-IT
(EUCTR)

04/06/2008

21/03/2008

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER

Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide

sanofi-aventis Groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Portugal;Italy

984

NCT00147966
(ClinicalTrials.gov)

June 2008

2/9/2005

Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies

Rheumatoid Arthritis

Drug: rituximab

University of California, San Diego

Genentech, Inc.

Completed

18 Years

75 Years

All

Phase 2

United States

985

NCT00711074
(ClinicalTrials.gov)

June 2008

3/7/2008

Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

Rheumatoid Arthritis

Drug: AZD5672

AstraZeneca

NULL

Completed

50 Years

N/A

Male

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

986

NCT00700986
(ClinicalTrials.gov)

June 2008

18/6/2008

Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056

A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study in Healthy Male Volunteers, to Investigate Retinal Function Following a Single 800mg Oral Dose of AZD9056

Rheumatoid Arthritis

Drug: AZD9056;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

65 Years

Male

Phase 1

United Kingdom

987

EUCTR2007-007539-14-SK
(EUCTR)

16/05/2008

16/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy

988

EUCTR2007-007539-14-LV
(EUCTR)

07/05/2008

12/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

989

EUCTR2007-005759-41-IT
(EUCTR)

06/05/2008

10/10/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ocrelizumab
Product Code: RO-496-4913

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Spain;Germany;United Kingdom;Italy

990

NCT01224418
(ClinicalTrials.gov)

May 2008

14/10/2010

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

18 Years

75 Years

Both

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

991

NCT00695188
(ClinicalTrials.gov)

May 2008

9/6/2008

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis A Multicenter, Randomized, Double-blind, Controlled Phase IV Trial

Rheumatoid Arthritis

Drug: methotrexate

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

NULL

Completed

18 Years

N/A

All

Phase 4

Austria

992

EUCTR2007-005759-41-GB
(EUCTR)

29/04/2008

29/02/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

France;Spain;Germany;Italy;United Kingdom

993

EUCTR2007-007539-14-MT
(EUCTR)

25/04/2008

12/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

994

NCT00673920
(ClinicalTrials.gov)

April 24, 2008

5/5/2008

A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo

Genentech, Inc.

Roche Pharma AG

Terminated

18 Years

N/A

All

314

Phase 3

United States

995

NCT00658047
(ClinicalTrials.gov)

April 2008

8/4/2008

A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

A Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CH-1504;Drug: Methotrexate (MTX)

Chelsea Therapeutics

NULL

Completed

18 Years

80 Years

Both

201

Phase 2

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

996

EUCTR2007-005759-41-FR
(EUCTR)

19/03/2008

12/02/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

997

NCT00641225
(ClinicalTrials.gov)

March 2008

18/3/2008

Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: SBI-087

Pfizer

Emergent Product Development Seattle LLC

Completed

18 Years

70 Years

Both

Phase 1

United States;Canada

998

NCT00650078
(ClinicalTrials.gov)

March 2008

28/3/2008

Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis

A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MR prednisone;Drug: Placebo

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

18 Years

80 Years

All

350

Phase 3

United States;Canada;Germany;Hungary;Poland;United Kingdom

999

EUCTR2007-001585-33-GR
(EUCTR)

26/02/2008

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

1000

EUCTR2006-006373-25-GR
(EUCTR)

26/02/2008

20/09/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1001

EUCTR2007-002066-35-IT
(EUCTR)

13/02/2008

07/09/2007

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND

CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: CP -690,550
Product Name: CP -690,550
Trade Name: Humira
INN or Proposed INN: Adalimumab

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece

1002

EUCTR2007-001420-12-CZ
(EUCTR)

16/01/2008

13/11/2007

A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

1003

EUCTR2007-001420-12-PL
(EUCTR)

20/12/2007

17/10/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

1004

EUCTR2007-001035-58-PT
(EUCTR)

14/12/2007

16/08/2007

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

Pfizer Inc, 235 East 42nd Street,New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

1005

NCT01231321
(ClinicalTrials.gov)

December 2007

28/10/2010

A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

100

Phase 3

Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1006

NCT00580229
(ClinicalTrials.gov)

December 2007

18/12/2007

A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: prednisone

University of South Florida

NULL

Completed

18 Years

80 Years

All

Phase 2;Phase 3

United States

1007

NCT00596206
(ClinicalTrials.gov)

December 2007

4/1/2008

Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis

Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients

Arthritis, Rheumatoid

Drug: leflunomide

Sanofi

NULL

Completed

18 Years

N/A

Both

124

Phase 3

Czech Republic;Italy;Korea, Republic of;Portugal;Romania

1008

EUCTR2007-001035-58-IT
(EUCTR)

21/11/2007

05/10/2007

Treatment of rheumatoid arthritis (RA).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

1009

EUCTR2006-006373-25-CZ
(EUCTR)

14/11/2007

20/09/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

1010

EUCTR2007-001585-33-LT
(EUCTR)

13/11/2007

05/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1011

EUCTR2007-000886-40-PT
(EUCTR)

09/11/2007

07/08/2007

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER

patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE

sanofi-aventis groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Portugal;Italy

1012

NCT00578305
(ClinicalTrials.gov)

November 2007

19/12/2007

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

185

Phase 3

Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom

1013

NCT00664573
(ClinicalTrials.gov)

November 2007

21/4/2008

Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients

Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Rheumatoid Arthritis

Biological: Baminercept alfa (BG9924)

Biogen Idec

NULL

Terminated

18 Years

75 Years

Both

339

Phase 2

Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom

1014

EUCTR2007-001035-58-ES
(EUCTR)

30/10/2007

26/07/2007

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A

ARTRITIS REUMATOIDERHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

Pfizer, S. A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

1015

EUCTR2007-001585-33-DK
(EUCTR)

26/10/2007

12/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1016

EUCTR2006-003768-67-ES
(EUCTR)

19/10/2007

10/09/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).

RHEUMATOID ARTHRITIS,NOSARTRITIS REUMATOIDE, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

1017

EUCTR2007-001420-12-FR
(EUCTR)

17/10/2007

23/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

1018

EUCTR2007-001420-12-SK
(EUCTR)

15/10/2007

18/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

France;Czech Republic;Slovakia;Poland;Belgium;Sweden

1019

EUCTR2007-001420-12-SE
(EUCTR)

12/10/2007

20/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

1020

EUCTR2006-003698-29-EE
(EUCTR)

12/10/2007

24/08/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;France;Estonia;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1021

EUCTR2007-001585-33-EE
(EUCTR)

10/10/2007

18/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

1022

EUCTR2007-001585-33-FR
(EUCTR)

09/10/2007

23/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania

1023

EUCTR2006-003698-29-IT
(EUCTR)

05/10/2007

03/04/2007

A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119

Rheumatoid Arthritis AR
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: AMG 108
Product Code: AMG 108

AMGEN S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1024

NCT00595517
(ClinicalTrials.gov)

October 2007

7/1/2008

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago

Drug: Esomeprazole 20 mg

AstraZeneca

NULL

Completed

20 Years

N/A

All

395

Phase 3

Japan

1025

EUCTR2007-001984-31-IT
(EUCTR)

28/09/2007

17/12/2007

A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - ND

CP-690,550 is an immunosuppressive agent being developed for the prevention of kidney allograft rejection, and for the treatment of rheumatoid arthritis as a disease-modifying anti-rheumatic drug.
MedDRA version: 9.1;Level: LLT;Classification code 10023439;Term: Kidney transplant rejection

Product Name: CP -690,550
Product Name: CP -690,550
Trade Name: SANDIMMUN NEORAL*50CPS 25MG
INN or Proposed INN: Ciclosporin
Trade Name: SANDIMMUN NEORAL*30CPS 100MG
INN or Proposed INN: Ciclosporin

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Portugal;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1026

EUCTR2007-001585-33-NL
(EUCTR)

20/09/2007

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands

1027

EUCTR2006-003768-67-AT
(EUCTR)

20/09/2007

26/04/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

1028

NCT00539760
(ClinicalTrials.gov)

September 5, 2007

4/10/2007

A Phase I Rheumatoid Arthritis Study in Healthy Volunteers

A Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy Volunteers

Arthritis, Rheumatoid

Drug: GSK1827771;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

1029

EUCTR2006-003698-29-LV
(EUCTR)

03/09/2007

04/09/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1030

NCT00411424
(ClinicalTrials.gov)

September 2007

12/12/2006

Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study

Rheumatoid Arthritis

Drug: ASK8007;Drug: Placebo

Astellas Pharma Inc

NULL

Completed

18 Years

N/A

Both

Phase 1;Phase 2

Belgium;Hungary;Ireland;Netherlands;Spain;United Kingdom;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

EUCTR2007-001420-12-BE
(EUCTR)

23/08/2007

09/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

France;Czech Republic;Poland;Belgium;Sweden

1032

EUCTR2007-001585-33-CZ
(EUCTR)

22/08/2007

04/09/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

1033

EUCTR2006-003698-29-IE
(EUCTR)

08/08/2007

12/01/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Estonia;France;Ireland;Italy;Latvia;Austria;Sweden;Hungary;United Kingdom;Czech Republic;Netherlands

1034

NCT00538902
(ClinicalTrials.gov)

August 2007

1/10/2007

Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Rheumatoid Arthritis

Biological: Placebo;Biological: Adalimumab 80 mg;Biological: Adalimumab 40 mg

Abbott

NULL

Completed

18 Years

N/A

All

302

Phase 2;Phase 3

China

1035

NCT00520572
(ClinicalTrials.gov)

August 2007

22/8/2007

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

Rheumatoid Arthritis

Drug: AZD9056;Drug: Etanercept;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

385

Phase 2

United States;Argentina;Australia;Belgium;Canada;Czech Republic;France;Mexico;Poland;Romania;Russian Federation;Slovakia;Hungary;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1036

NCT00542789
(ClinicalTrials.gov)

August 2007

11/10/2007

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago

Drug: Esomeprazole;Drug: Placebo

AstraZeneca

NULL

Completed

20 Years

N/A

All

343

Phase 3

Japan

1037

EUCTR2007-001585-33-LV
(EUCTR)

26/07/2007

30/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

1038

EUCTR2006-003698-29-AT
(EUCTR)

18/07/2007

16/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1039

EUCTR2007-000886-40-CZ
(EUCTR)

17/07/2007

30/05/2007

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER

Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE

sanofi-aventis groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

Portugal;Czech Republic;Italy

1040

EUCTR2006-003698-29-HU
(EUCTR)

16/07/2007

29/05/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

NCT00664716
(ClinicalTrials.gov)

July 2007

21/4/2008

Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Rheumatoid Arthritis

Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

391

Phase 2

Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom

1042

EUCTR2006-001553-10-DE
(EUCTR)

19/06/2007

21/02/2007

A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
Trade Name: Methotrexat 2,5 mg Tabletten medac
Product Name: Methotrexate (MTX)
INN or Proposed INN: Methotrexate
Other descriptive name: MTX

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

1043

EUCTR2006-003768-67-GB
(EUCTR)

01/06/2007

12/02/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden

1044

NCT00491933
(ClinicalTrials.gov)

June 2007

25/6/2007

Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFa Antagonists

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in the Assessment of Latent Mycobacterium Tuberculosis Infection in Patients Candidate to Treatment or Treated With TNFa Antagonists

Rheumatoid Arthritis;Spondylarthritis;Tuberculosis

Procedure: Quantiferon-TB Gold assay;Procedure: Tuberculin skin test

Ospedale L. Sacco – Polo Universitario

NULL

Recruiting

18 Years

80 Years

Both

100

N/A

Italy

1045

NCT00422227
(ClinicalTrials.gov)

June 2007

11/1/2007

Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

70 Years

All

300

Phase 4

Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1046

EUCTR2007-000082-38-DK
(EUCTR)

24/05/2007

26/03/2007

The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study

In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira (adalimumab)
Product Name: Humira® (adalimumab)
Product Code: 2593
INN or Proposed INN: Adalimumab

Aarhus University Hospital, Denmark

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

Denmark

1047

EUCTR2006-001553-10-NL
(EUCTR)

23/05/2007

02/04/2007

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

1048

EUCTR2006-003768-67-NL
(EUCTR)

16/05/2007

27/03/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

1049

EUCTR2006-006373-25-SE
(EUCTR)

04/05/2007

16/03/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

1050

NCT00420199
(ClinicalTrials.gov)

May 2007

8/1/2007

A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate

Active Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 3

Belgium;Germany;Netherlands;Spain;Sweden;United Kingdom;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1051

NCT00578565
(ClinicalTrials.gov)

May 2007

19/12/2007

Rituximab in Rheumatoid Arthritis Lung Disease

Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study

Rheumatoid Arthritis;Interstitial Pneumonia

Drug: Rituximab

Eric Matteson

Genentech, Inc.;National Center for Research Resources (NCRR)

Completed

18 Years

80 Years

All

Phase 3

United States

1052

NCT00504595
(ClinicalTrials.gov)

May 2007

19/7/2007

Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis

A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885

Rheumatoid Arthritis

Drug: ACZ885 (investigational);Drug: Placebo

Novartis

NULL

Completed

18 Years

75 Years

All

Phase 2

Russian Federation;Spain;Switzerland;Turkey

1053

EUCTR2006-003768-67-BE
(EUCTR)

27/04/2007

23/04/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden

1054

EUCTR2006-006373-25-SK
(EUCTR)

20/04/2007

03/04/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

1055

EUCTR2006-006032-22-GB
(EUCTR)

04/04/2007

26/02/2007

TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA

Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.

University of Manchester

Dudley Group of Hospitals NHS Trust

Not Recruiting

Female: yes
Male: yes

5350

Phase 3

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

EUCTR2006-006373-25-ES
(EUCTR)

23/03/2007

24/01/2007

ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550

Pfizer, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

1057

EUCTR2006-003768-67-SE
(EUCTR)

23/03/2007

07/02/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

1058

EUCTR2006-001553-10-BE
(EUCTR)

20/03/2007

21/02/2007

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands;Germany;Italy

1059

EUCTR2006-003768-67-DE
(EUCTR)

19/03/2007

19/02/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-2007)

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom;Germany;Netherlands;Spain;Austria;Sweden

1060

NCT00487825
(ClinicalTrials.gov)

March 2007

18/6/2007

Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)

Novartis

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Germany;Italy;Netherlands;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1061

EUCTR2006-006380-22-DE
(EUCTR)

22/02/2007

28/12/2006

Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry

Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate
MedDRA version: 8.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: ERMM-1
INN or Proposed INN: erbium citrate

CIS bio international

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

1062

EUCTR2006-006373-25-AT
(EUCTR)

15/02/2007

12/02/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

1063

EUCTR2004-002993-49-EE
(EUCTR)

02/02/2007

23/02/2005

A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

1064

NCT00427934
(ClinicalTrials.gov)

February 2007

25/1/2007

Maraviroc in Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

Arthritis, Rheumatoid

Drug: Maraviroc;Drug: Maraviroc Placebo

Pfizer

NULL

Terminated

18 Years

N/A

All

128

Phase 2

United States;Australia;Germany;India;Italy;Mexico;Portugal;Spain;Ukraine

1065

EUCTR2006-001553-10-IT
(EUCTR)

26/01/2007

15/05/2007

A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND

Early rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1066

EUCTR2006-003698-29-BE
(EUCTR)

18/12/2006

13/11/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

France;Estonia;Hungary;Czech Republic;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden

1067

EUCTR2006-003698-29-GB
(EUCTR)

14/12/2006

29/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;Czech Republic;United Kingdom;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1068

NCT00413452
(ClinicalTrials.gov)

December 2006

15/12/2006

Etanercept SFP in RA Patients

Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Etanercept

Amgen

Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

Both

224

Phase 3

United States;Canada

1069

NCT00761514
(ClinicalTrials.gov)

November 2006

25/9/2008

Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira

Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)

Rheumatoid Arthritis

Drug: Humira (adalimumab)

Abbott

NULL

Terminated

18 Years

N/A

All

Phase 4

Puerto Rico

1070

EUCTR2006-003698-29-NL
(EUCTR)

26/10/2006

14/06/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

EUCTR2005-002219-26-HU
(EUCTR)

25/10/2006

19/04/2006

A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis”

Rheumatoid Arthritis patients with CRP higher than 10 mg/L

Product Code: SB 681323

GlaxoSmithKline

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

1072

EUCTR2006-003843-22-IT
(EUCTR)

24/10/2006

30/08/2006

prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study

rheumatoid arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: HUMIRA *SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: DELTACORTENE FORTE*10CPR 25MG
INN or Proposed INN: Prednisone

OSPEDALE POLICLINICO S. MATTEO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

1073

EUCTR2006-003698-29-CZ
(EUCTR)

20/10/2006

29/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1074

EUCTR2006-003698-29-SK
(EUCTR)

19/10/2006

29/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Phase 2

Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden

1075

EUCTR2006-003698-29-FR
(EUCTR)

05/10/2006

14/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1076

EUCTR2006-003698-29-SE
(EUCTR)

03/10/2006

17/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1077

EUCTR2006-005391-40-IT
(EUCTR)

25/09/2006

05/06/2007

Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND

Patients with Rheumatoid Arthritis
Level: PTClassification code 10039073

Product Name: Platelet Rich Plasma
INN or Proposed INN: Triamcinolone

AZIENDA OSPEDALIERA SENESE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1078

EUCTR2005-002219-26-NO
(EUCTR)

05/09/2006

18/07/2005

A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)

Rheumatoid arthritis (RA)

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

1079

NCT01308255
(ClinicalTrials.gov)

September 2006

3/3/2011

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid

University of Leeds

NULL

Completed

18 Years

80 Years

All

112

Phase 4

United Kingdom

1080

NCT01126541
(ClinicalTrials.gov)

September 2006

18/5/2010

SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

224

Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1081

NCT00369473
(ClinicalTrials.gov)

September 2006

24/8/2006

Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 108

Amgen

NULL

Completed

18 Years

N/A

Both

690

Phase 2

Australia;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Puerto Rico;Slovakia;Spain;United Kingdom;United States

1082

NCT00367211
(ClinicalTrials.gov)

September 2006

18/8/2006

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)

POZEN

NULL

Completed

18 Years

N/A

Both

400

Phase 3

United States

1083

EUCTR2005-002326-63-EE
(EUCTR)

09/08/2006

26/08/2005

A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1084

NCT00326339
(ClinicalTrials.gov)

August 2006

12/5/2006

Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis

Drug: R788;Drug: Placebo

Rigel Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

189

Phase 2

United States;Mexico

1085

EUCTR2006-004062-13-IT
(EUCTR)

18/07/2006

30/08/2006

Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A.

RHEUMATOID ARTHRITIS
MedDRA version: 6.1;Level: PT;Classification code 10039073

Trade Name: DEPALGOS*20+325MG 28CPR RP
INN or Proposed INN: OXICODONE DC.IT
INN or Proposed INN: PARACETAMOLO DC.IT FU

A.U.S.L. RIMINI

NULL

Not Recruiting

Female: yes
Male: yes

149

Phase 2

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1086

NCT01272908
(ClinicalTrials.gov)

July 18, 2006

7/1/2011

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

120

Phase 3

Canada;Sweden

1087

NCT00872573
(ClinicalTrials.gov)

July 1, 2006

30/3/2009

A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.

Rheumatoid Arthritis;Osteoarthritis;Post-traumatic Arthritis;Collagen Disorders;Avascular Necrosis;Traumatic Femoral Fractures;Nonunion of Femoral Fractures;Congenital Hip Dysplasia;Slipped Capital Femoral Epiphysis

Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)

DePuy International

NULL

Terminated

60 Years

80 Years

All

Phase 4

United Kingdom

1088

EUCTR2006-001359-36-NL
(EUCTR)

02/06/2006

29/03/2006

Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION

Patients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis.

Trade Name: Ascal(r) / carbasalate calcium

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1089

EUCTR2005-005013-37-GB
(EUCTR)

06/04/2006

20/01/2006

A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA

Early Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

112

Phase 4

United Kingdom

1090

NCT00319917
(ClinicalTrials.gov)

April 2006

27/4/2006

A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Rheumatoid Arthritis

Drug: tacrolimus;Drug: placebo

Astellas Pharma Inc

NULL

Completed

20 Years

64 Years

Both

123

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1091

EUCTR2005-002219-26-GB
(EUCTR)

20/03/2006

13/01/2006

Rheumatoid arthritis (RA)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

1092

EUCTR2005-002629-30-LV
(EUCTR)

27/02/2006

01/03/2006

A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1093

EUCTR2005-003436-21-CZ
(EUCTR)

15/02/2006

07/11/2005

A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Germany;United Kingdom;Czech Republic

1094

EUCTR2005-002629-30-CZ
(EUCTR)

15/02/2006

01/02/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1095

EUCTR2005-002629-30-EE
(EUCTR)

13/02/2006

23/02/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Lithuania;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1096

EUCTR2005-002629-30-SK
(EUCTR)

03/02/2006

04/01/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Estonia;Czech Republic;Slovakia;Lithuania;Latvia

1097

NCT00502996
(ClinicalTrials.gov)

February 2006

17/7/2007

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

246

Phase 3

Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela

1098

NCT00296257
(ClinicalTrials.gov)

February 2006

22/2/2006

Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis (RA)

Drug: SMP-114

Dainippon Sumitomo Pharma Europe LTd.

NULL

Terminated

18 Years

N/A

Both

312

Phase 2

Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom

1099

EUCTR2005-002629-30-LT
(EUCTR)

30/01/2006

06/12/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

634

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1100

EUCTR2005-003436-21-DE
(EUCTR)

18/01/2006

24/10/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;United Kingdom;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1101

NCT00264147
(ClinicalTrials.gov)

January 2006

9/12/2005

Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: etoricoxib;Drug: Comparator: placebo;Drug: Comparator: diclofenac

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

761

Phase 2

Canada;Colombia;Puerto Rico;Switzerland;United States

1102

NCT00254293
(ClinicalTrials.gov)

January 2006

15/11/2005

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)

Rheumatoid Arthritis

Drug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

1103

NCT00346294
(ClinicalTrials.gov)

January 2006

27/6/2006

An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept

Amgen

Immunex Corporation

Completed

18 Years

N/A

All

115

Phase 4

United States

1104

EUCTR2005-003436-21-HU
(EUCTR)

15/12/2005

11/10/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073

Product Name: SMP-114
Product Code: SMP-114

Sumitomo Pharmaceuticals Europe Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;Germany;United Kingdom

1105

EUCTR2004-002482-20-GB
(EUCTR)

02/12/2005

15/02/2005

A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study

Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid Arthritis

Trade Name: Efexor XL 75 mg
Product Name: Efexor XL 75 mg (venlafaxine)
Product Code: NA
INN or Proposed INN: Venlafaxine Hydrochloride

Newcastle upon Tyne Hospitals NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1106

NCT00669942
(ClinicalTrials.gov)

December 2005

29/4/2008

Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose

Rheumatoid Arthritis

Biological: AIN457;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

104

Phase 1;Phase 2

United States;Belgium;Germany;Netherlands;Singapore;Spain

1107

EUCTR2005-002219-26-IT
(EUCTR)

11/11/2005

16/03/2007

Rheumatoid arthritis RA
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: SB-681323
Product Code: SB-681323
Product Name: SB-681323
Product Code: SB-681323

GLAXO SMITHKLINE

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

1108

EUCTR2005-002219-26-DE
(EUCTR)

09/11/2005

20/07/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

1109

NCT00160641
(ClinicalTrials.gov)

November 2005

8/9/2005

A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

567

Phase 3

United States;Bulgaria;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro

1110

NCT00162292
(ClinicalTrials.gov)

November 2005

9/9/2005

Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

Rheumatoid Arthritis

Drug: BMS-582949 and Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States;Mexico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1111

NCT00320450
(ClinicalTrials.gov)

November 2005

28/4/2006

SB-681323 In Subjects With Rheumatoid Arthritis

A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid

Drug: SB-681323

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary

1112

EUCTR2005-002326-63-LV
(EUCTR)

28/10/2005

22/11/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1113

EUCTR2005-003436-21-GB
(EUCTR)

26/10/2005

05/09/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;Germany;United Kingdom

1114

NCT00249041
(ClinicalTrials.gov)

October 2005

3/11/2005

Enbrel Liquid Immunogenicity Protocol

Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: 50 mg Etanercept;Drug: Enbrel liquid

Amgen

Immunex Corporation

Completed

18 Years

N/A

Both

447

Phase 3

United States;Canada

1115

EUCTR2005-002219-26-ES
(EUCTR)

21/09/2005

10/10/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1116

EUCTR2005-002326-63-LT
(EUCTR)

21/09/2005

04/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1117

EUCTR2005-002326-63-SK
(EUCTR)

20/09/2005

05/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Estonia;Czech Republic;Slovakia;Lithuania;Latvia

1118

EUCTR2005-002219-26-SE
(EUCTR)

08/09/2005

14/07/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

1119

EUCTR2005-002326-63-CZ
(EUCTR)

05/09/2005

08/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

634

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

1120

EUCTR2005-000551-15-GB
(EUCTR)

05/09/2005

05/08/2005

Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate

Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction.

Product Name: Allopurinol
Product Code: Allopurinol
INN or Proposed INN: Allopurinol
Product Name: Folic acid
Product Code: Folic acid
INN or Proposed INN: Folic acid

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1121

NCT00691028
(ClinicalTrials.gov)

September 2005

3/6/2008

Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kg

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

20 Years

75 Years

All

327

Phase 3

NULL

1122

EUCTR2005-002219-26-DK
(EUCTR)

23/08/2005

09/08/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

1123

EUCTR2005-001350-24-FI
(EUCTR)

04/08/2005

23/06/2005

A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania

1124

EUCTR2005-001350-24-HU
(EUCTR)

01/08/2005

19/05/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

1125

EUCTR2005-001350-24-EE
(EUCTR)

18/07/2005

14/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1126

EUCTR2005-001350-24-LT
(EUCTR)

14/07/2005

08/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

1127

NCT00109408
(ClinicalTrials.gov)

July 2005

27/4/2005

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

673

Phase 3

United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro

1128

NCT00503425
(ClinicalTrials.gov)

June 30, 2005

17/7/2007

A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.

An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent

Rheumatoid Arthritis

Drug: Rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

215

Phase 3

Israel

1129

EUCTR2005-001350-24-LV
(EUCTR)

21/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

1130

EUCTR2004-002993-49-DE
(EUCTR)

10/06/2005

25/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

NCT00160602
(ClinicalTrials.gov)

June 2005

8/9/2005

A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

590

Phase 3

United States;Bulgaria;Chile;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro

1132

NCT00175877
(ClinicalTrials.gov)

June 2005

9/9/2005

A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

857

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Estonia;Finland;France;Hungary;Israel;Latvia;Lithuania;Mexico;New Zealand;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro;Netherlands;Spain;Sweden

1133

EUCTR2005-001350-24-SK
(EUCTR)

31/05/2005

21/04/2005

A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia

1134

EUCTR2005-001350-24-CZ
(EUCTR)

27/05/2005

04/05/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

1135

EUCTR2004-002993-49-GB
(EUCTR)

17/05/2005

23/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;United Kingdom;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1136

EUCTR2004-002993-49-BE
(EUCTR)

05/05/2005

19/07/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Estonia;Czech Republic;Hungary;Finland;Belgium;Lithuania;Latvia;Sweden

1137

NCT00106522
(ClinicalTrials.gov)

May 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

499

Phase 3

United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom

1138

NCT01270087
(ClinicalTrials.gov)

May 2005

4/1/2011

The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

Rheumatoid Arthritis

Drug: Adalimumab

Skåne University Hospital

Abbott;The Swedish Research Council;The Swedish Rheumatism Ass;Crafoord Foundation

Completed

18 Years

N/A

Both

Phase 4

Sweden

1139

NCT00106574
(ClinicalTrials.gov)

April 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

1220

Phase 3

United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand

1140

EUCTR2004-002993-49-FI
(EUCTR)

29/03/2005

16/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Hungary;Finland;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1141

EUCTR2004-004302-24-DE
(EUCTR)

23/03/2005

11/01/2005

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA

Merck & Co. Inc.

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

1142

EUCTR2004-000074-31-BE
(EUCTR)

15/03/2005

07/07/2004

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Merck Sharp & Dohme BV

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Belgium;Sweden

1143

EUCTR2004-002993-49-SE
(EUCTR)

15/03/2005

05/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania;Sweden

1144

EUCTR2004-004302-24-CZ
(EUCTR)

09/03/2005

04/02/2005

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: PARALEN 500
Product Name: PARALEN 500
Product Code: 8594739041288
INN or Proposed INN: paracetamol
Other descriptive name: NA

Merck & Co., Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Germany;Czech Republic;Spain;Italy

1145

EUCTR2004-004302-24-IT
(EUCTR)

09/03/2005

10/08/2007

A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: L-883191

MERCK SHARP DOHME

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Czech Republic;Germany;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1146

EUCTR2004-002993-49-LV
(EUCTR)

28/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

1147

EUCTR2004-004302-24-ES
(EUCTR)

16/02/2005

04/11/2005

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA

Merck & Co. Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

1148

EUCTR2004-002993-49-CZ
(EUCTR)

11/02/2005

04/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Germany;Czech Republic;Estonia;Latvia;Sweden;Lithuania

1149

EUCTR2004-002993-49-HU
(EUCTR)

11/02/2005

15/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

1150

EUCTR2004-002993-49-LT
(EUCTR)

09/02/2005

03/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1151

EUCTR2004-002993-49-SK
(EUCTR)

08/02/2005

31/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden

1152

NCT00152386
(ClinicalTrials.gov)

February 2005

7/9/2005

A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Certolizumab pegol (CDP870)

UCB Pharma

NULL

Completed

18 Years

N/A

All

950

Phase 3

Croatia;Czechia;Israel;Latvia;Russian Federation;Ukraine;United States;Czech Republic;Argentina;Australia;Belgium;Bulgaria;Canada;Chile

1153

NCT00124449
(ClinicalTrials.gov)

February 2005

30/6/2005

Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Arthritis, Rheumatoid

Drug: Abatacept;Drug: placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Australia;Belgium;France;Germany;Italy;Mexico;Puerto Rico;Spain;United Kingdom

1154

EUCTR2004-004302-24-FI
(EUCTR)

18/01/2005

17/11/2004

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Suomen MSD Oy

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

1155

NCT00123149
(ClinicalTrials.gov)

January 2005

19/7/2005

Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA)

Anemia;Rheumatoid Arthritis

Drug: Epoetin alfa

Ortho Biotech Products, L.P.

NULL

Withdrawn

18 Years

99 Years

Both

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

NCT00365001
(ClinicalTrials.gov)

January 2005

15/8/2006

A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: Simvastatin

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;New Zealand

1157

NCT00106535
(ClinicalTrials.gov)

January 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1196

Phase 3

United States;Australia;Brazil;China;Denmark;Finland;France;Greece;Italy;Mexico;Norway;Poland;Puerto Rico;South Africa;Spain;Switzerland

1158

NCT00106548
(ClinicalTrials.gov)

January 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

623

Phase 3

Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain

1159

NCT00132769
(ClinicalTrials.gov)

January 2005

2/8/2005

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK-0873;Drug: Comparator: Placebo

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

All

106

Phase 2

Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland

1160

NCT00650390
(ClinicalTrials.gov)

October 2004

28/3/2008

Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Approved for marketing

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1161

NCT00242853
(ClinicalTrials.gov)

October 2004

19/10/2005

A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)

Rheumatoid Arthritis;Osteoarthritis

Procedure: Power doppler ultrasonography;Procedure: High frequency ultrasonography;Procedure: Exhaled nitric oxide assessment

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

Both

N/A

United Kingdom

1162

NCT00094341
(ClinicalTrials.gov)

October 2004

16/10/2004

Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

Both

215

Phase 4

United States

1163

EUCTR2004-001490-26-GB
(EUCTR)

15/09/2004

01/06/2005

A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA

RHEUMATOID ARTHRITIS

Trade Name: Asendis 50 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Amoxapine & dipyridamole

CombinatoRx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Estonia;United Kingdom

1164

EUCTR2004-000612-54-SE
(EUCTR)

11/09/2004

07/07/2004

A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study

Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037

Merck Sharp & Dohme (Sweden) AB

NULL

Not Recruiting

Female: yes
Male: yes

1360

Phase 2

Sweden

1165

EUCTR2004-000074-31-SE
(EUCTR)

06/07/2004

21/05/2004

rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)

Merck Sharp & Dohme (Sweden) AB

NULL

Not Recruiting

Female: yes
Male: yes

150

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1166

NCT00236678
(ClinicalTrials.gov)

July 2004

7/10/2005

Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT

A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT? (Epoetin Alfa)

Anemia;Rheumatoid Arthritis

Drug: Epoetin alfa

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Terminated

18 Years

N/A

Both

Phase 2

NULL

1167

NCT00542022
(ClinicalTrials.gov)

June 2004

5/10/2007

Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients

Arthritis, Rheumatoid

Drug: MK0812 / Duration of Treatment: 12 Weeks;Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

Both

149

Phase 2

NULL

1168

NCT00110903
(ClinicalTrials.gov)

May 2004

16/5/2005

Treatment for Subjects With Active Rheumatoid Arthritis (RA)

Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Etanercept Liquid

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

1169

NCT00224562
(ClinicalTrials.gov)

February 2004

14/9/2005

The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis

Drug: TNF-alpha antagonists

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

N/A

Both

N/A

France

1170

NCT00157872
(ClinicalTrials.gov)

January 7, 2004

7/9/2005

A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

150

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

NCT00378261
(ClinicalTrials.gov)

January 2004

15/9/2006

APART Advanced Profiling of Anti-Rheumatic Therapies

A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

N/A

Both

1079

Phase 4

NULL

1172

NCT00649922
(ClinicalTrials.gov)

October 2003

28/3/2008

Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

20 Years

N/A

Both

226

Phase 4

NULL

1173

NCT00235859
(ClinicalTrials.gov)

July 2003

7/10/2005

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Rheumatoid Arthritis

Drug: adalimumab;Drug: methotrexate

Abbott

Eisai Limited

Completed

18 Years

N/A

Both

128

Phase 3

NULL

1174

NCT00647920
(ClinicalTrials.gov)

July 2003

28/3/2008

Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Study of the Human Anti-TNF-Antibody Adalimumab

Rheumatoid Arthritis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

18 Years

N/A

Both

Phase 3

Taiwan

1175

NCT00213538
(ClinicalTrials.gov)

June 2003

13/9/2005

Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Response to anakinra associated with methotrexate

University Hospital, Rouen

NULL

Completed

18 Years

N/A

All

341

N/A

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

NCT00074438
(ClinicalTrials.gov)

June 2003

12/12/2003

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo

Genentech, Inc.

Roche Pharma AG

Completed

18 Years

80 Years

Both

465

Phase 2

United States

1177

NCT00213564
(ClinicalTrials.gov)

April 2003

13/9/2005

Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: response to infliximab associated with methotrexate

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

France

1178

NCT00160693
(ClinicalTrials.gov)

March 2003

6/9/2005

Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

402

Phase 3

United Kingdom;Austria;Belgium;Czechia;Germany;Ireland;United States;Czech Republic

1179

NCT00121043
(ClinicalTrials.gov)

October 2002

30/6/2005

Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire

An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire

Rheumatoid Arthritis

Device: SimpleJectTM;Drug: Kineret® (Anakinra)

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 4

NULL

1180

NCT00448383
(ClinicalTrials.gov)

September 2002

14/3/2007

A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-a Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Completed

18 Years

N/A

Both

6610

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1181

NCT02093026
(ClinicalTrials.gov)

August 2002

19/3/2014

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid

Hoffmann-La Roche

Genentech, Inc.

Completed

21 Years

N/A

All

465

Phase 2

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom

1182

NCT00038298
(ClinicalTrials.gov)

April 2002

29/5/2002

A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: AMG 719;Drug: AGM 719;Drug: placebo to AMG 719

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

1183

NCT00036153
(ClinicalTrials.gov)

March 2002

8/5/2002

Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate

Rheumatoid Arthritis

Drug: Tacrolimus (Prograf®);Drug: Methotrexate

Astellas Pharma Inc

Astellas Pharma US, Inc.

Completed

18 Years

N/A

Both

210

Phase 3

United States;Canada

1184

NCT00524160
(ClinicalTrials.gov)

July 2001

31/8/2007

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.

Arthritis;Osteoarthritis;Rheumatoid Arthritis

Drug: Fentanyl transdermal patch

Janssen Pharmaceutica N.V., Belgium

NULL

Completed

18 Years

N/A

Both

264

Phase 4

NULL

1185

NCT00014794
(ClinicalTrials.gov)

April 2001

11/4/2001

Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients

H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: 15-O labeled water

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1186

NCT00195650
(ClinicalTrials.gov)

July 2000

13/9/2005

Long Term Open Label Continuation Study

A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

846

Phase 3

United States;Canada

1187

NCT02247375
(ClinicalTrials.gov)

January 2000

19/9/2014

Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)

A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks

Arthritis, Rheumatoid

Drug: Low dose of BIIL 284 BS tablets;Drug: High dose of BIIL 284 BS tablets;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

65 Years

Both

Phase 1

NULL

1188

NCT02932644
(ClinicalTrials.gov)

October 1999

12/10/2016

Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.

Rheumatoid Arthritis;Cardiovascular Disease

Other: Baseline serum vitamin D level below 50 nmol/l;Other: Baseline serum vitamin D level at or above 50 nmol/l

Odense University Hospital

The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN);The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN)

Completed

18 Years

75 Years

Both

160

N/A

NULL

1189

NCT00012506
(ClinicalTrials.gov)

October 1999

10/3/2001

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Uveitis;Arthritis, Juvenile Rheumatoid

Drug: TNFR:Fc

National Eye Institute (NEI)

NULL

Recruiting

2 Years

18 Years

Both

Phase 3

United States

1190

NCT00001862
(ClinicalTrials.gov)

February 1999

3/11/1999

TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis;Uveitis

Drug: Enbrel

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1191

NCT00001614
(ClinicalTrials.gov)

July 1997

3/11/1999

The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis

Arthritis, Juvenile Rheumatoid;Uveitis

Drug: Chicken type II collagen

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 1

United States

1192

JPRN-JapicCTI-121843

28/05/2012

OSKIRA-Asia-1

A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 75mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 50mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
Control intervention name : Placebo
Dosage And administration of the control intervention : twice daily for 12 weeks

AstraZeneca

NULL

BOTH

Phase 2

NULL

1193

EUCTR2010-023692-26-DE
(EUCTR)

07/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

370

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

1194

EUCTR2008-000744-13-DE
(EUCTR)

07/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Belgium;Bulgaria;Germany;Italy

1195

JPRN-JapicCTI-080531

21/02/2008

A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use

Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention name : esomeprazole
Dosage And administration of the intervention : Oral

AstraZeneca

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1196

EUCTR2011-002896-40-ES
(EUCTR)

26/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

1197

EUCTR2019-000878-30-EE
(EUCTR)

12/05/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;Lithuania;United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of

1198

JPRN-JapicCTI-111601

05/09/2011

Rheumatoid Arthritis

Intervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : s.c. i.v.

Novartis Pharma K.K.

NULL

BOTH

Phase 3

NULL

1199

EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)

08/03/2012

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Female: yes
Male: yes

170

Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico

1200

JPRN-JapicCTI-121990

22/10/2012

OSKIRA-Asia-1X

A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg once daily

AstraZeneca

NULL

BOTH

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1201

JPRN-JapicCTI-080565

09/04/2008

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use

Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention name : esomeprazole
Dosage And administration of the intervention : Oral

AstraZeneca

NULL

BOTH

Phase 3

NULL

1202

JPRN-JapicCTI-050146

12/10/2005

Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion

Mitsubishi Tanabe Pharma Corporation

NULL

BOTH

Phase 3

NULL

1203

JPRN-JapicCTI-080650

23/10/2008

Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.

Rheumatoid Arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15
Control intervention name : Placebo
Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 2

NULL

1204

EUCTR2016-003630-25-BG
(EUCTR)

17/07/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand