DDrare: Database of Drug Development for Rare Diseases

97. 潰瘍性大腸炎
［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］

Searched query = "Ulcerative colitis"
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 = (-)-3-(4-Aminophenyl)-2-methoxypropionic acid; (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid; (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride; -aminosalicylic acid; 0.25 mg RPC1063; 0.25mg RPC103; 0.25mg RPC1063; 0.5 mg RPC1063; 1 mg RPC1063; 1.0 mg RPC103; 1.0 mg RPC1063; 1.Remicade; 10 mg Natura-alpha capsule; 100; 100 mg; 150 mg; 1500mg mesalazine pellets; 15N2-tofacitinib; 2 x 10 mg Natura-alpha capsules; 2'-Fucosyllactose; 2-Hydroxybenzoic acid; 20 mg; 225mg SHP647 (PF-00547659); 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 250mg mesalazine pellets; 2L polyethylene glycol/ascorbic acid; 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III); 331731-18-1; 40 mg MSB11022; 42942019; 450 mg; 5 ASA, enemas, suppositories, corticosteroids; 5-ASA; 5-ASA (5-Aminosalicylate); 5-ASA MMx; 5-AminoSalicylic Acid; 5-Aminosalicyclic acid; 5-Aminosalicylic Acid; 5-Aminosalicylic acid; 5-Aminosalicylic acid (5-ASA); 5-Aminosalicylic acid(5-ASA) and/or Prednisone; 5-HTP; 5-amino salicylic acid; 5-amino salicylic acid (5-ASA); 5-amino-2-hydroxybenzoic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5-aminosalicylic acid (5-ASA); 50 mg; 500mg mesalazine pellets; 549-0261/F02-01; 6 mercaptopurine; 6-MP; 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid; 6-mercaptopurine; 75 mg Ontamalimab; 750mg mesalazine pellets; 75mg SHP647 (PF-00547659); 90 mg hydrocortisone acetate suppository with Sephure suppository applicator; A multistrain probiotic product (DSF); A07DA03; A: 1 dosis; AB (antibiotics); ABBV-006; ABBV-066; ABBV-323; ABBV-323 Dose A; ABBV-323 Dose B; ABI-M201; ABT-494; ABT-Humira; ABX464; ABX464 100mg; ABX464 25mg; ABX464 50mg; ADALIMUMAB; AEB071; AEB071A; AG011; AG011 - Capsules; AG011 - Enema; AJG501; AJG511; AJM300; ALLOPURINOL; ALTH12-1:4; ALTH12-2:4; AMG 181; AMG181; AMGEVITA; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMT; AMT-101; AMT-101 (oral); AND (Andrographolide); ANDROGRAPHIS PANICULATA; ANDROGRAPHIS PANICULATA (ethanol extract); AODG (Apigenin-7-O-glucuronide); APD334; APREMILAST; APRISO 375 mg extended-release capsules; APVO210; AR401959 L-arginine; AS; AS INN; ASA; ASACOL; ASC; ASP015K; ASP3291; AST-120; ATL-2502; AVONEX; AVX 470; AZA; AZAFOR 50mg; AZATHIOPRINE; AZATIOPRINA; AbGn-168H; Abalimumab; Abatacept; Abatacept (ABA); Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetate; Acetic acid; Acidophilus; Active group; Adalimumab; Adipate; Adipose derived, autologous mesenchymal stem cells; Adipose tissue-derived mesenchymal stem cells; Adipose-cord mesenchymal stromal cells (A-MSCs); Air; Aldesleukin; Alicaforsen; Alkaline Phosphatase; Allogeneic adipose tissue-derived mesenchymal stem cells; Allopurinol; AloASC; Aloe; Aloe Barbadensis Miller; Amg 181; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminosalicylic acid; Amitriptyline; Amitriptyline hydrochloride; Amoxicillin; Amoxicillin and tetracycline; Amoxicillin, metronidazole and tetracycline; Anakinra; Andecaliximab; AndoSan; Andrographolide; Anrukinzumab; Anti Beta7; Anti CD3 monoclonal antibody; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 monoclonal antibody; Anti-IP-10 Antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TL1A; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Antibiotic cocktail; Apigenin; Apixaban; Apixaban 2.5 milligram; Apremilast; Apriso 0.375G ER CAP; Aquamin®; Arginine; Asacol; Asacol (mesalamine); Asacol (mesalamine) Delayed-release Tablets; Asacol 400 mg; Asacol 400 mg (mesalamine); Asacol 400 mg tablet; Asacol 400mg tablet; Asacol 800 mg (mesalamine); Asacol 800 mg tablet; Asacol 800mg tablet; Asacol Delayed Release Tablets; Asacol Delayed-Release Tablets; Asacol tablet; Asacol®; Asacol® 400 mg; Ascorbic Acid; Ascorbic acid; Aspergillus oryzae; Avonex; Azathioprine; Azathioprine (AZA); Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine (Imuran) 50 mg Overencapsulated Tablet; Azathioprine and Allopurinol; Azathioprine or 6-mercaptopurine; Azatioprina; B2-ASmedic; B: 2 dosis; BBT-401-1S; BBT-401-1S, Multiple doses; BBT-401-1S, Single dose; BECLOMETASONE DIPROPIONATE; BG9418 (Interferon beta-1a); BG9924; BI 655130; BIAP; BITTER CANDYTUFT FRESH PLANT EXTRACT; BL-7040; BMS-188667; BMS-936557; BMS-986165; BMS-986165 Dose 1; BMS-986165 Dose 2; BMS-986166; BMS-986184; BMS986165; BRAZIKUMAB; BT-11; BT-11 (1000 mg); BT-11 (500 mg); BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriotherapy; Balsalazide; Balsalazide Disodium; Balsalazide disodium; Baminercept; Band; Bascial prescription plus or minus herbs depend on symptoms; Basiliximab; Beclometasone; Beclometasone dipropionate; Beclomethasone dipropionate; Beclomethasone diproprionate; Behavioral: AbbVie Care 2.0; Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus); Behavioral: Increased dietary intake of salmon or cod; Behavioral: TIP / IMPACT Plus Care Coordination; Berberine; Berberine Chloride; Bertilimumab; Beta-1,3/1,6-D-Glucan; Bezlotoxumab; Bifidobacterium breve; Bifidobacterium infantis; Bifidobacterium infantis 35624; Bimekizumab; Bio-enhanced Curcumin Soft Gelatin Capsule; Biologically active human fecal microbiota; Biopsies; Biosimilar; Biosimilar infliximab; Bitterschleifenblume-ganzpflanze 1,5ml/10ml; Blood sample; Blood samples; Boulardii; Bovine intestinal alkaline phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase BIAP; Brazikumab; Broccoli; Budenofalk 2mg rectal foam; Budenofalk 3mg; Budenofalk rectal foam; Budenofalk® suppositories; Budenofalk® suppositories (BUS); Budesonide; Budesonide (6 mg); Budesonide (9 mg); Budesonide 6 mg capsules, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide 9 mg capsules, hard (BUX-PV); Budesonide 9 mg capsules, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide MMX; Budesonide MMX 6 mg Tablet; Budesonide MMX®; Budesonide MMX® 6 mg; Budesonide MMX® 9 mg; Budesonide-MMX; Budesonide-MMX®; Budesonide-MMX® 6 mg; Budesonide-MMX® 9 mg; Budesonide-MMX™; Butanoic acid; Butyrate; By demand; CANNABIDIOL; CARVI EXTRACTUM FLUIDUM; CAT-354; CB-01-02; CB-01-05-MMX; CC; CC-10004; CD; CGMP protein; CICLOSPORIN; CLA; CLA (Chlorogenic acid); CLIPPER*30CPR 5MG R.M.; CNTO 148; CNTO-148; CNTO1275; CNTO148; CNTO1959; CNTO312; COFFEE COAL; COLAL PRED; COLAL-PRED; COLAL-PRED®; CP; CP- 690 550; CP-690,500 5 mg; CP-690,550; CP-690,550 10 mg; CP-690,550-10; CP690,550; CS (corticosteroids) Only; CT-P13; CT-P13 SC (Infliximab); CYCLOSPORIN; CYCLOSPORINE VS INFLIXIMAB; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcium; Caltrate Pill; Cannabidiol; Cannabis; Cannabis, Medical; Carbon; Carbon dioxide; Carnitine; Carrageenan; Casein; Casein glycomacropeptide (CGMP); Catridecacog; Ceftriaxone; Cefuroxime; Certolizumab pegol; Chloride; Chlorogenic Acid; Cholecalciferol; Ciclosporin; Ciclosporina; Cimzia; Ciprofloxacin; Clarithromycin; Clipper; Clipper 30 cpr 5mg R.M.; Clotrimazole; Coamoxiclav; Cobitolimod; Coffee; Colal-Pred; Colazide; Coltect; Combination Oral Budesonide and Rectal Hydrocortisone; Combination Product: Beclomethasone dipropionate in addition to MC-EVOO; Combination Product: Beclomethasone dipropionate in addition to refined oil; Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator; Corticosteroid; Corticosteroids; Corticosteroids only; CortimentMMX 9 mg; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Cotrimoxazole; Curcumin; CyCol; CyCol™; Cyclosporin; Cyclosporine; Cyclosporine (USAN); Cytochrome P450 (CYP) Substrates; D-Proline; DACORTIN; DAND (14-Deoxyandrographolide); DDAND (14-deoxy-11,12-didehydroandrographolide); DELTACORTENE FORTE*10CPR 25MG; DELTACORTENE*20CPR 5MG; DEXTRAN 1 FOR INJECTION; DIMS0150; DIMs0150; Daclizumab; Dacortin; Decortin H; Decortin H 1 mg; Decortin H 10mg; Decortin H 20mg; Decortin H 50 mg; Decortin H 5mg; Dekavil; Dekristol; Delayed and extended release mesalazine; Deligoparin; Delmitide acetate; Deltacortene; Deltacortene 10 cpr 25mg; Deltacortene 20 cpr 5mg; Dersalazina sodica; Dersalazine; Dersalazine sodium; Device: The Colonic Transendoscopic enteral Tubing.; Dexamethasone; Dexamethasone 21-phosphate; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: Antibodies to golimumab; Diagnostic Test: Calprotectin; Diagnostic Test: Colonoscopy; Diagnostic Test: Golimumab trough levels; Diagnostic Test: Histology; Diagnostic Test: Rectosigmoidoscopy; Diagnostic Test: parasitological diagnostics (coproscopy); Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet; Doxycycline; Dukoral; E. coli Nissle; E6007; EGF enema; EMEA/H/C/000240; EMEA/H/C/000481; EN; ENTOCORT CR; ENTYVIO; ETROLIZUMAB; Ecologic 825; Eicosapentaenoic Acid; Eicosapentaenoic acid; Encapsulated Mesalamine Granules (eMG); Encapsulated faecal microbiota; Encapsulated faecal microbiota filtrate; Entecavir; Entocort EC® 3 mg; Entocort® CR; Entyvio; Entyvio 300 mg; Entyvio 300mg; Epaxal Berna (virosomal hepatitis A vaccine); Epidermal growth factor; Epidermal growth factor enema; Ergocalciferol; Ethanol; Etrasimod; Etrasimod L-arginine; Etrolizumab; Etrozulimab; Exposure to golimumab; F8IL10; FE 999301; FILGOTINIB; FITC-ADALIMUMAB; FITC-Adalimumab; FMT; FMT enema; FMT infusions; FMT oral; FP-110; FP-CYA-050; FP-CYA-053; Factor XIII; Faecal Microbiota Transplant; Faecal Microbiota Transplantation; Faecal matter; Fecal Microbial Transplant; Fecal Microbial Transplantation; Fecal Microbiota; Fecal Microbiota Enema; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal Microbiota Transplantation (FMT), OpenBiome; Fecal microbiota; Fecal microbiota capsule; Fecal microbiota transplantation; Ferric carboxymaltose; Ferrous sulphate; Filgotinib; Film-coated tablet; Flagyl; Flaxseed; Flaxseed lignan-enriched complex (FLC); Flixabi; Fluorescein; Flupentixol; Fosfomycin; Freeze-dried black raspberry powder; G321605; GB004; GED-0301; GED-0507-34-LEVO; GED-0507-34-Levo; GED-0507-34-Levo 160 mg; GED-0507-34-Levo 80 mg; GED0507; GI-270384; GLPG0974; GLPG1205; GLPG3970; GLYCYRRHIZA GLABRA ROOT; GOLIMUMAB; GS-4875; GS-5745; GS-5745 IV; GS-5745 SC; GS-6034; GSK1399686; GSK1605786; GSK1605786A; GSK2586184 400mg; GSK2831781; GSK2831781 IV infusion; GSK2831781 SC injection; GSK2982772; GSK2982772A, where A denotes the free base; GUSELKUMAB; GWP42003; Ganciclovir; Gastro-resistant phosphatidylcholine granules; Gelatin; Genetic: TPMT genotyping; Gliolan; Glutamine; Glycyrrhiza; Glycyrrhiza glabra; Gold; Golimumab; Golimumab (GLM); Golimumab (Optimization); Golimumab 1 mg per kg; Golimumab 100 mg; Golimumab 2 mg per kg; Golimumab 200 mg; Golimumab 4 mg per kg; Golimumab 400 mg; Golimumab 50 mg; Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Golimumab Dose 1; Golimumab Dose 2; Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Prefilled Syringe; Golimumab treatment optimization.; Gralise; Granulated mesalamine; Grapefruit; Group 1- Control Diet; Group 2- UCD Diet; Guaiazulene; Guselkum; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; H02AB; HE3286; HF2; HGS1025; HMPL-004; HMPL-004 1800 mg/day; HMPL-004 2400 mg/day; HMPL-004 high dose; HMPL-004 low dose; HMPL004-6599; HUMIRA; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HYDROCORTISONE ACETATE; Hemay007; Hepatitis A Vaccine; Herbal treatment (SA100); Hextend; Hgd40; High Dose Budesonide; High dose; HuM291; HuM291); Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-IP10 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Humanized recombinant IgG4 monoclonal antibody against CD-127; Humira; Humira (adalimumab original); Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg solution for injection in pre-filled syringes; Humira 40 mg/0.8 ml solution for injection; Humira 40 mg/0.8 ml solution for injection for paediatric use; Humira®; Hyaluronate; Hydrocortisone; Hydrocortisone acetate; Hydrocortisone sodium succinate; Hydrogen; Hydroxide; Hydroxocobalamin; Hydroxocobalamin with Butyrate; IBD98-M; IBD98-M Delayed-release Capsules; IDOFORM®Travel; IM90838; IMU-838; INCB039110; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITACITINIB ADIPATE; IV Corticosteroid; Iberogast N; Imolope; Impact; Imuran; Imurek; Imurek 25mg Filmtabletten; Imurek 50mg Filmtabletten; Imurel; Inflectra; Inflectra 100 mg; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX); Infliximab 10 mg/kg; Infliximab 5 mg/kg; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab, adalimumab, certolizumab pegol; Innovator infliximab; Inositol; Interferon beta; Interferon beta-1a; Interferon-beta; Interferon-beta-1a; Interferon-beta-1a, 44 microgram; Interferon-beta-1a, 66 microgram; Interleukin 2; Interleukin-2 (aldesleukin).; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; Itacitinib; JNJ-54781532 150 mg once daily; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 75 mg twice daily; JNJ-54781532-AAD-10 mg; JNJ-54781532-AAD-30 mg; JNJ-54781532-AAD-5 mg; JNJ-66525433; K(D)PT; KHK4083; KRP203; KRP203A; Kamillenblüten 3ml/10ml; Kappaproct; KdPT; Kremezin; Kremezin®, Spherical Adsorptive Carbon; Kyo-Dophilus; Kümmel 2ml/10ml; L-Carnitine; L-Lysyl-D-Prolyl-L-Threonine Acetate; L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate; LC51-0255; LDP-02; LIXACOL; LOPERAMIDE; LT-02; LT-02 (modified-release PC pellets); LX1606; LY3074828; LYC-30937; LYC-30937-EC; LYS006; Lactated Ringers; Lactobacillus GG; Lactobacillus casei DG; Lactobacillus plantarum; Lactobacillus reuteri; Lactobacillus rhamnosus GG ATCC 53103; Lactobacillus salivarius UCC118; Lactobacilus acidophilus & bifidobacterium animalis/lactis; Lactose; Lactose in water; Leucine; Levocarnitine; Levocarnitine propyl hydrochloride; Linaclotide; Lixacol; Loperamide; Loperamide hydrochloride; Losartan; Low Dose Budesonide; Low FODMAP; Low dose; Low dose naltrexone; Lumbar puncture; Lysine; Lysine-D-Proline-Threonine; Lysine-D-proline-threonine; MATRICARIA FLOWER; MATRICARIA RECUTITA L. FLOS; MD-0901; MDX-1100; MDX-1100 (anti-CXCL10 human monoclonal antibody); MEDI7183 high dose; MEDI7183 low dose; MEDI7183 medium dose; MELISSAE FOLII DRY AQUEOUS EXTRACT; MENTHA × PIPERITA L. FOLIUM; MERCAPTOPURINE; MESALAZINA; MESALAZINE; MESENCHYMAL CELLS; MET-2; METHOTREXATE; METHOTREXATE DISODIUM; METHYLENE BLUE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; MEZAVANT; MIRIKIZUMAB; MK-8259; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MMX Mesalamine; MMX Mesalamine/Mesalazine; MMX Mesalamine/Mesalazine (High Dose); MMX Mesalamine/Mesalazine (Low Dose); MMX mesalamine/ mesalazine; MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MTX; MTX 12.5; MTX 25; MYRRH; Magnesium; Magnesium citrate; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mare´s milk; Matricaria Flower; Maximal oral 5ASA; Melatonin; Melissenblätter 15ml/10ml; Melitracen; Mercaptopurine; Mercaptopurine (Puri-Nethol); Mercaptopurine (Purinethol); Mesalamin; Mesalamine; Mesalamine Delayed Release Tablets 400mg; Mesalamine Enema; Mesalamine Granules; Mesalamine Once-Daily; Mesalamine Twice-Daily; Mesalamine granules; Mesalamine, 5-ASA; Mesalamine, 5-aminosalicylic acid [5-ASA]; Mesalazina; Mesalazine; Mesalazine (3,600 mg); Mesalazine (Asacol®); Mesalazine - TID 1000 mg; Mesalazine - TID 2x 500 mg; Mesalazine 1000 mg gastro-resistant tablets; Mesalazine 250Mg; Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet; Mesalazine 4G Enema; Mesalazine 500 mg gastro-resistant tablets (Salofa; Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg); Mesalazine Enema; Mesalazine enema; Mesalazine liquid enema; Mesalazine slow-release granules; Mesalazine tablet; Mesalazine with hydrocortisone sodium succinate; Mesalazinum; Mesenchymal Stromal Cells; Mesenchymal stromal cells; Methotrexate; Methotrexate bellon; Methotrexate bellon 25mg/ml; Methotrexate injection; Methylene blue; Methylene blue 25mg tablets; Methylprednisolone; Metoject; Metronidazole; Metronidazole capsule 50 mg; Mezavant; Mezavant 1200 mg magensaftresistente Retardtabletten; Mezavant Gastro-resistant, prolonged release tablets; Mezavant XL; Mezavant XL 1200 mg gastro-resistant prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.; Mezavant XL 1200mg gastro-resistant, prolonged release tablets; Mezavant XL Gastro-resistant, prolonged release tablets; Midazolam; Midazolam 2 mg; Mirikizumab; Mirikizumab IV; Mirikizumab SC; MitoQ; Modified Gegen Qinlian Decoction; Modified-release phosphatidylcholine; Mongersen; MultiStem; MultiStem high dose; MultiStem low dose; Multiple dose- Group B; Multiple dose-Group B; Multistem; Mycodigest supplement; Myrrh; Myrrhinil-Intest®; N.a.; NAND (Neoandrographolide); ND; NEORAL; NX-13 250 mg; Naltrexone; Nanocort; Neomycin; Neoral Soft Gelatin Capsules; Niclosamide; Nicolon; Nitazoxanide; Nitazoxanide 500Mg Oral Tablet; Nivolumab; Nolpitantium Besylate; Nolpitantium besylate; Non as of yet; None; None given; Normal Saline Enema; Null; Nutrition supplement; Nutritional dietary intervention; Nuvion®); OPC-6535; OPC-6535 Tablets (drug); OPC-6535(Tetomilast); OPRX-106; OPRX-106 (plant cells expressing TNFR-Fc) 2mg; OPRX-106 (plant cells expressing TNFR-Fc) 8mg; ORE1001; OSE-127; OST-122; Oats; Omeprazole; Omeprazole 20 mg; Ondansetron; Ondansetron hydrochloride dihydrate; Ontamalimab; Oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Oral Corticosteroids; Oral OKT3; Orencia; Originator (legacy) drug; Oseltamivir; Other: 0 mg; Other: 100% pomegranate juice; Other: Additional Therapies; Other: Control; Other: Control group(Normal saline); Other: Conventional drugs; Other: Faecal bacterial transplantation; Other: Fast Mimicking Diet; Other: Hyperbaric Oxygen Therapy; Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Measurement of drug (Adalimumab/Infliximab); Other: Mesalazine; Other: Other Biologic Agents; Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA); Other: Saline; Other: Therapy Education; Other: Threonine; Other: Ulcerative Colitis Diet; Other: dietary intervention with no-carrageenan diet; Other: e-Monitoring; Other: pretreatment antibiotics; Overencapsulated Azathioprine (Imuran) 50 mg Tablet; Overencapsulated mesalazine tablets; Oxygen; Ozanimod; Ozanimod hydrochloride; PARNAPARIN SODIUM; PBF-677; PCT (PureCell Technologies Complex); PEG; PEG-liposomal prednisolone sodium phosphate; PF 06687234; PF-00547659; PF-00547659 SC Injection; PF-05230917; PF-05285401; PF-06480605; PF-06480605 100 mg/ml; PF-06651600; PF-06651600 10 mg; PF-06651600 50 mg; PF-06651600-15; PF-06687234; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PF-06826647; PF-06826647 100 mg QD; PF-06826647 300 mg QD; PF-06826647 600 mg QD; PF-6826647 400 mg QD; PN-10884A; PN-943; PRD5973697; PREDNISOLONE; PREDNISOLONE SODIUM PHOSPHATE; PREDNISONE; PRIM-DJ2727; PRO145223; PRO145223 (RO5490261); PROPIONYL L-CARNITINE; PROPIONYL L-CARNITINE HYDROCHLORIDE; PRV-300; PS; PS-QD; PS-SP; PTG-100; PUR 0110; PUR 0110 Rectal Enema; PUR 0110 Rectal Enema 1000 mg; PUR 0110 Rectal Enema 250 mg; PUR 0110 Rectal Enema 500 mg; PV; Palmitoleic Acid; Palmitoleic acid; Parnaparin; Pending; Pentasa; Pentasa 2g sachet prolonged release granules (95%); Pentasa 500 mg Retardtabletten; Pentasa Compact 2g, granulate with prolonged release; Pentasa Compact 4g, granulate with prolonged release; Pentasa Sachet; Pentasa Sachet 1 g; Pentasa Sachet 1g; Pentasa Sachet 2 g; Pentasa enema; Pentasa prolonged release granules 2g; Pentasa sachet 1g; Pfefferminzblätter 1ml/10ml; Phosphate; Phosphatidylcholine; Photodynamic therapy with Gliolan; Picosulfate; Placebo; Polaprezinc; Polyethylene glycol; Polyphenon E®; Pomegranate; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisolone Sodium Phosphate; Prednisolone Tablets B.P. 5mg; Prednisolone sodium metasulphobenzoate; Prednisone; Prefilled Syringe delivery of Golimumab; Previously referred to as MEDI2070 and AMG 139; Probiotic; Probiotic Formula Capsule; Probiotic Mixture; Probiotics; Procedure: Biopsies; Procedure: Blood sampling, endoscopy; Procedure: Colectomy; Procedure: Colonoscopy; Procedure: Colorectal biopsies; Procedure: Enema; Procedure: FMT; Procedure: Fecal microbiota transplantation; Procedure: Gastroscopy; Procedure: Hyperbaric oxygen; Procedure: Infusion of Saline; Procedure: Narrow Band Imaging; Procedure: Rectal dialysis; Procedure: Sham Hyperbaric Air; Procedure: Standardized FMT; Procedure: Stool samples; Procedure: colonoscopy; Procedure: lumbar puncture; Procedure: rectosigmoidoscopy; Procedure: sigmoidoscopy; Products containing aminosalicylate; Products containing azathioprine or 6-mercaptopurine; Proline; Promiten; Propionyl-L-Carnitine; Propionyl-L-carnitine; Propionylcarnitinhydrochlorid; Psyllium; Psyllium Husk Powder; Psyllium husk; Puri-Nethol; QBECO SSI; RAVAGALIMAB; RDP58; RECTABUL2mg rectal form; REMICADE; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RIBOFLAVIN; RISANKIZUMAB; RO5490261 / F02; RO5490261/F02; RO5490261/F04-02; RO7049665; RO7246311; ROSUVASTATIN CALCIUM; RPC1063; RTNV148B IgG; Raspberry; Ravagalimab; Rebamipide; Recombinant Factor XIII (rFXIII); Rectal dialysis; Rectal tacrolimus; Regular treatment; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (CT-P13); Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; Retarded Release Phosphatidylcholine (rPC); Retarded release phosphatidylcholine; RhIL-11; RhuMAb Beta7; RhuMAb Beta7, Anti Beta 7, PRO145223; RhuMAb Beta7, Anti Beta7, PRO145223; RhuMab Beta7, Anti Beta7, PRO145223; Riboflavin; Rifaximin; Risankizumab; Risankizumab (Genetical Recombination); Risankizumab IV; Risankizumab SC; Rituximab; Rivenprost; Rivenprost (drug); Ro 549-0261/F04; Rosiglitazone; Rosuvastatin; Rosuvastatine EG; SANDINUM; SAR339658; SB-656933; SB-656933 Tablets; SB012; SB5; SC12267; SC12267 (4SC-101); SCH 900050; SER-287; SF257 C59; SHINGRIX; SHP647; SHR0302; SIMPONI; SODIUM HYALURONATE; SOYBEAN PHOSPHATIDYLCHOLINE; SPD476; SPD476 (mesalazine); SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine; SPESOLIMAB; SR140333B; SRT2104; ST 261; ST-0529; ST10-021; ST261; STELARA®; STNM01; STNM01 1.84 mg; STW5-II; STW5-II (Iberogast N, BAY98-7410); SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML; Salicylic acid; Saline; Salmon; Salofalk; Salofalk 1000mg Granu-Stix; Salofalk 1000mg Granu-Stix®; Salofalk 1000mg Granu-stix®; Salofalk 3g gastro-resistant prolonged-release granules; Salofalk 4g/60ml Klysma; Salofalk Granu-Stix 500 mg; Salofalk® 1000mg Granu-Stix®; Salofalk® 500 mg gastro-resistant tablet; Salofalk® 500 mg tablets; Salofalk® 500mg; Salofalk® 500mg Granu-Stix®; Sandimmum; Sandimmun; Sandimmun 50 mg/ml, infuusiokonsentraatti; Sandimmun Neoral; Semi-vegetarian diet; Serum bovine immunoglobulin; Shingrix; Simponi; Simponi (Golimumab); Simponi®; Simponi® (Golimumab); Simulect; Single dose-group A; Smartject Device delivery of Golimumab; Smoking cigarettes; Smoking of cannabis; Sodium Picosulfate/Magnesium Citrate Laxative; Solu-Medrol; Solu-medrol; Sotrastaurin; Sotrastaurin (INN) acetate; Soybean; Spesolimab; Spesolimab IV infusion; Spesolimab SC solution for injection; Standard 2 hours-infusion; Standard Therapy; Standardized FODMAP; Standardized anthocyanin-rich extract; Stasis; Stelara; Sterile saline for injection; Steroids; Sucrose; Sugar Extract; Sulphsalazine, Pentasa, Asacol, Colazide, Depentum; Suspension de microbiote fécal; Synergy-1; Synergy1; Sübetaholzwurzel 1ml/10ml; Süßholzwurzel 1ml/10ml; TA-650; TA-650 (Infliximab); TD-1473; TD-1473 Dose A; TD-1473 Dose B; TD-1473 Dose C; TD-3504; THRX-139060; TJ301 300mg; TJ301 600mg; TOFACITINIB; TOP1288; TOP1288 Rectal solution; TOP1288 rectal solution; TP05; TP05 Coating A; TP05 Coating B; TP05 Coating D; TP05 Coating E; TP05 Coating H; TREMFYA®; TSO; Tacrolimus; Tauroursoursodeoxycholic acid, brand name Tudcabil; Telotristat; Telotristat Etiprate; Telotristat etiprate; Terbinafine; Tetomilast; Tetracycline; Thalidomide; Thalidomide Pharmion; Threonine; To be confirmed; To be requested; Tofacitinib; Tofacitinib citrate; Tofacitinib citrate (Phase III Formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercialFormulation - debossed); Tofacitinib citrate (clinical trial image); Traditional treatments; Tralokinumab; Treatment Algorithm A; Treatment Algorithm B; Treatment Algorithm C; Tremfya; Trexan; Trexan inj 25 mg/ml; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Tris; UCB4940; UCMSC group; UDCA; UR-12746-S; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); Umbilical Cord Mesenchymal Stem Cells; Unknown; Upadacitinib; Upadacitinib (ABT-494); Upadacitinib - Direct compression-yellow; Upadacitinib - Wet Granulation-Yellow; Upadacitinib -Direct compression-yellow; Updacitinib (ABT-494); Urbason; Ursodeoxycholic acid; Ursodiol; Ursodiol (ursodeoxycholic acid, UDCA); Ursofalk; Ustekinumab; Ustekinumab Dose Based on BSA and Body Weight; Ustekinumab IV; Ustekinumab IV Infusion; Ustekinumab SC; Ustekinumab SC Injection; Usual current care; V565; VB-201; VB-201 160mg; VEDOLIZUMAB; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vaccine Vivotif + Vaccine Dukoral; Vaccine Vivotif + Vaccine Dukoral + oats; Valganciclovir; Vaminolac; Vaminolac, komb.; Vamorolone; Vamorolone 4% suspension for oral dosing; Vancomycin; Vancomycin Pre-Treat; Vancomycin Pre-Treatment; Vatelizumab; Vedolizumab; Vedolizumab 108 mg SC; Vedolizumab 300 mg; Vedolizumab 300 mg IV; Vedolizumab IV; Vedolizumab IV, Placebo IV, Placebo SC; Vedolizumab IV, Placebo SC; Vedolizumab Injection; Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vidofludimus; Vidofludimus calcium; Vidofludimus calcium dihydrate; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Visilizumab (HuM291; Visilizumab (Nuvion); Visilizumab (Nuvion®; Vitamin B2; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vivotif; Warfarin; Warfarin 10 mg; Water; Wharton Jelly Mesenchymal stem cells; XELJANZ; Xeljanz; Xeljanz 5 mg film-coated tablets; Xeljanz 5mg film-coated tablets; Z-206; Zessly; Zoenasa-1:4; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [BI 655130]; [CC-10004]; [N/A]

No.	TrialID	Date_ enrollment	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	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study	Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
2	NCT04131322 (ClinicalTrials.gov)	October 2019	10/10/2019	Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.	Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Not yet recruiting	18 Years	N/A	All	216	Phase 4	NULL
3	EUCTR2013-004279-11-FR (EUCTR)	03/06/2019	09/04/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
4	EUCTR2013-004277-27-HU (EUCTR)	11/04/2019	25/02/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
5	EUCTR2013-004277-27-CZ (EUCTR)	18/03/2019	29/03/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;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
6	EUCTR2015-001346-29-CZ (EUCTR)	13/11/2017	03/06/2016	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden
7	EUCTR2016-001409-18-NO (EUCTR)	06/12/2016	09/05/2016	A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence	A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Helse More og Romsdal Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Norway
8	NCT02750800 (ClinicalTrials.gov)	April 7, 2016	13/4/2016	Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)	Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE	Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis	Biological: Adalimumab;Behavioral: AbbVie Care 2.0	AbbVie	NULL	Completed	18 Years	99 Years	All	427		Hungary
9	EUCTR2015-001346-29-GB (EUCTR)	08/02/2016	28/09/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use 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	93	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden
10	EUCTR2015-001346-29-HU (EUCTR)	02/02/2016	28/09/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;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
11	EUCTR2015-000939-33-GB (EUCTR)	06/11/2015	29/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
12	EUCTR2013-003032-77-PL (EUCTR)	05/11/2015	28/08/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use 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	93	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand
13	EUCTR2013-004279-11-BG (EUCTR)	12/01/2015	06/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
14	EUCTR2013-004277-27-BG (EUCTR)	12/01/2015	06/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
15	EUCTR2013-004277-27-GR (EUCTR)	08/12/2014	08/12/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;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
16	EUCTR2013-001682-16-PL (EUCTR)	08/12/2014	22/09/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
17	EUCTR2013-001682-16-NL (EUCTR)	28/11/2014	01/05/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan
18	EUCTR2013-004279-11-SK (EUCTR)	13/11/2014	08/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
19	EUCTR2013-003032-77-CZ (EUCTR)	06/11/2014	31/07/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use 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	93	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand
20	EUCTR2013-003032-77-GB (EUCTR)	30/10/2014	19/12/2013	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use 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	85	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;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
21	EUCTR2013-004279-11-EE (EUCTR)	03/10/2014	09/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
22	EUCTR2013-004277-27-LT (EUCTR)	30/09/2014	22/07/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
23	EUCTR2013-001682-16-DE (EUCTR)	22/09/2014	10/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
24	EUCTR2013-003032-77-IT (EUCTR)	10/09/2014	19/12/2013	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 3	United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
25	EUCTR2013-001682-16-IT (EUCTR)	02/09/2014	23/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	525	Phase 3	United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;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
26	EUCTR2013-001682-16-CZ (EUCTR)	21/08/2014	18/06/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
27	EUCTR2013-004277-27-HR (EUCTR)	12/08/2014	05/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
28	EUCTR2013-004277-27-LV (EUCTR)	28/07/2014	21/07/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
29	EUCTR2013-001682-16-AT (EUCTR)	03/07/2014	16/06/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
30	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
No.	TrialID	Date_ enrollment	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	EUCTR2013-001682-16-HU (EUCTR)	18/06/2014	22/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	525		United States;Hungary;Slovakia;Canada;Israel;Japan;Switzerland
32	EUCTR2013-001682-16-SK (EUCTR)	10/06/2014	29/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
33	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
34	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
35	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
No.	TrialID	Date_ enrollment	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	EUCTR2011-002411-29-PL (EUCTR)	19/12/2013	17/10/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
37	EUCTR2011-002411-29-CZ (EUCTR)	15/11/2013	16/09/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
38	EUCTR2011-002411-29-SK (EUCTR)	11/11/2013	14/10/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
39	EUCTR2011-006084-22-GB (EUCTR)	04/10/2012	15/08/2012	Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment	Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease	Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab	Royal Liverpool University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	0		United Kingdom
40	EUCTR2011-002411-29-ES (EUCTR)	10/08/2012	18/10/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;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
41	NCT01670240 (ClinicalTrials.gov)	August 2012	8/8/2012	Adalimumab in the Treatment of Chronic Pouchitis	Adalimumab (Humira) in the Treatment of Chronic Pouchitis	Ulcerative Colitis;Pouchitis	Drug: Adalimumab;Drug: Placebo	Odense University Hospital	University of Southern Denmark;Hvidovre University Hospital;Aarhus University Hospital;AbbVie	Completed	18 Years	N/A	Both	13	Phase 3	Denmark
42	EUCTR2011-002411-29-FI (EUCTR)	29/06/2012	11/06/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
43	EUCTR2011-002411-29-AT (EUCTR)	26/06/2012	01/02/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
44	EUCTR2011-002411-29-PT (EUCTR)	01/06/2012	03/01/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
45	EUCTR2011-002411-29-DE (EUCTR)	11/05/2012	11/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;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
46	EUCTR2011-002411-29-GB (EUCTR)	03/05/2012	07/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
47	EUCTR2011-002411-29-SE (EUCTR)	26/04/2012	13/10/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
48	EUCTR2011-002411-29-DK (EUCTR)	30/03/2012	28/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
49	EUCTR2011-002411-29-IE (EUCTR)	30/03/2012	09/02/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
50	EUCTR2011-002411-29-BE (EUCTR)	07/03/2012	23/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;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
51	EUCTR2011-002411-29-IT (EUCTR)	20/02/2012	07/03/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	ABBOTT GMBH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden
52	EUCTR2011-002411-29-GR (EUCTR)	09/01/2012	07/12/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
53	EUCTR2011-004268-31-DK (EUCTR)	13/12/2011	21/11/2011	Adalimumab (Humira) in the treatment of chronic pouchitis	Adalimumab (Humira) in the treatment of chronic pouchitis	Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringes Product Name: Humira Product Code: EMEA/H/C/000481	Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	24		Denmark
54	EUCTR2007-004157-28-SE (EUCTR)	22/10/2009	06/05/2009	Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden
55	EUCTR2007-004157-28-PT (EUCTR)	17/03/2009	12/12/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;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
56	EUCTR2007-004157-28-NL (EUCTR)	09/12/2008	10/12/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
57	EUCTR2007-004157-28-DE (EUCTR)	07/08/2008	25/03/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden
58	EUCTR2007-004157-28-SK (EUCTR)	04/08/2008	09/04/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
59	EUCTR2007-004157-28-HU (EUCTR)	09/07/2008	28/03/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia
60	EUCTR2007-004157-28-BE (EUCTR)	23/06/2008	13/12/2007	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;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
61	EUCTR2007-004157-28-CZ (EUCTR)	09/06/2008	10/04/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
62	EUCTR2006-002781-20-SE (EUCTR)	23/05/2008	04/03/2008	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
63	EUCTR2007-004157-28-AT (EUCTR)	30/04/2008	08/04/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden
64	EUCTR2006-002782-40-AT (EUCTR)	16/03/2008	20/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
65	EUCTR2006-002781-20-AT (EUCTR)	27/02/2008	23/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	475		Hungary;Germany;Czech Republic;Italy;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
66	EUCTR2006-002782-40-DE (EUCTR)	20/02/2008	18/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria
67	EUCTR2006-002782-40-PT (EUCTR)	07/09/2007	18/06/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria
68	EUCTR2006-002781-20-BE (EUCTR)	16/07/2007	10/01/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	475		Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden
69	EUCTR2006-002782-40-DK (EUCTR)	09/07/2007	07/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
70	EUCTR2006-002781-20-DE (EUCTR)	27/06/2007	04/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Czech Republic;Germany;Italy;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
71	EUCTR2006-002782-40-FR (EUCTR)	19/06/2007	06/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
72	EUCTR2006-002782-40-BE (EUCTR)	19/06/2007	05/01/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany
73	EUCTR2006-002782-40-CZ (EUCTR)	18/06/2007	10/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
74	EUCTR2006-002781-20-CZ (EUCTR)	04/05/2007	16/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
75	EUCTR2006-002782-40-HU (EUCTR)	18/04/2007	20/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;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
76	EUCTR2006-002781-20-IT (EUCTR)	17/04/2007	07/03/2007	A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND	A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND	Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: HUMIRA	Abbott GmbH Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
77	EUCTR2006-002781-20-HU (EUCTR)	26/03/2007	28/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
78	EUCTR2006-002782-40-ES (EUCTR)	23/03/2007	05/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany
79	EUCTR2006-002781-20-SK (EUCTR)	19/03/2007	01/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575	Phase 3	Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden
80	EUCTR2015-001346-29-SE (EUCTR)		30/09/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	NA			Female: yes Male: yes	93	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;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
81	EUCTR2015-001346-29-AT (EUCTR)		12/01/2016	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	NA			Female: yes Male: yes	93	Phase 3	United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden
82	EUCTR2014-004559-29-Outside-EU/EEA (EUCTR)		12/11/2014	A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis	A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	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 Inc.	NULL	NA			Female: yes Male: yes	274		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

EUCTR2020-001811-26-NL
(EUCTR)

30/09/2020

08/07/2020

IBD under control with less medication

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study

Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB

University Medical Center Groningen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Netherlands

NCT04131322
(ClinicalTrials.gov)

October 2019

10/10/2019

Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.

Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study

Crohn Disease;Ulcerative Colitis

Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

NULL

Not yet recruiting

18 Years

N/A

All

216

Phase 4

NULL

EUCTR2013-004279-11-FR
(EUCTR)

03/06/2019

09/04/2019

A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

EUCTR2013-004277-27-HU
(EUCTR)

11/04/2019

25/02/2019

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

EUCTR2013-004277-27-CZ
(EUCTR)

18/03/2019

29/03/2019

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;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

EUCTR2015-001346-29-CZ
(EUCTR)

13/11/2017

03/06/2016

A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden

EUCTR2016-001409-18-NO
(EUCTR)

06/12/2016

09/05/2016

A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence

A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: 1.Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Helse More og Romsdal Hospital Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

NCT02750800
(ClinicalTrials.gov)

April 7, 2016

13/4/2016

Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis

Biological: Adalimumab;Behavioral: AbbVie Care 2.0

AbbVie

NULL

Completed

18 Years

99 Years

All

427

Hungary

EUCTR2015-001346-29-GB
(EUCTR)

08/02/2016

28/09/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
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

Phase 3

United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden

EUCTR2015-001346-29-HU
(EUCTR)

02/02/2016

28/09/2015

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;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

EUCTR2015-000939-33-GB
(EUCTR)

06/11/2015

29/10/2015

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

758

Phase 3

Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany

EUCTR2013-003032-77-PL
(EUCTR)

05/11/2015

28/08/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
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

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand

EUCTR2013-004279-11-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

EUCTR2013-004277-27-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

EUCTR2013-004277-27-GR
(EUCTR)

08/12/2014

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;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

EUCTR2013-001682-16-PL
(EUCTR)

08/12/2014

22/09/2014

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

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

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

EUCTR2013-001682-16-NL
(EUCTR)

28/11/2014

01/05/2014

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan

EUCTR2013-004279-11-SK
(EUCTR)

13/11/2014

08/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

EUCTR2013-003032-77-CZ
(EUCTR)

06/11/2014

31/07/2014

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
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

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand

EUCTR2013-003032-77-GB
(EUCTR)

30/10/2014

19/12/2013

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
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

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;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

EUCTR2013-004279-11-EE
(EUCTR)

03/10/2014

09/09/2014

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

EUCTR2013-004277-27-LT
(EUCTR)

30/09/2014

22/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

EUCTR2013-001682-16-DE
(EUCTR)

22/09/2014

10/04/2014

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

EUCTR2013-003032-77-IT
(EUCTR)

10/09/2014

19/12/2013

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

EUCTR2013-001682-16-IT
(EUCTR)

02/09/2014

23/04/2014

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

525

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;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

EUCTR2013-001682-16-CZ
(EUCTR)

21/08/2014

18/06/2014

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

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

EUCTR2013-004277-27-HR
(EUCTR)

12/08/2014

05/09/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

EUCTR2013-004277-27-LV
(EUCTR)

28/07/2014

21/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

EUCTR2013-001682-16-AT
(EUCTR)

03/07/2014

16/06/2014

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-001682-16-HU
(EUCTR)

18/06/2014

22/04/2014

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

525

United States;Hungary;Slovakia;Canada;Israel;Japan;Switzerland

EUCTR2013-001682-16-SK
(EUCTR)

10/06/2014

29/04/2014

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

840

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-002411-29-PL
(EUCTR)

19/12/2013

17/10/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2011-002411-29-CZ
(EUCTR)

15/11/2013

16/09/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

EUCTR2011-002411-29-SK
(EUCTR)

11/11/2013

14/10/2013

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

EUCTR2011-006084-22-GB
(EUCTR)

04/10/2012

15/08/2012

Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease

Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab

Royal Liverpool University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

EUCTR2011-002411-29-ES
(EUCTR)

10/08/2012

18/10/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;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

NCT01670240
(ClinicalTrials.gov)

August 2012

8/8/2012

Adalimumab in the Treatment of Chronic Pouchitis

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Ulcerative Colitis;Pouchitis

Drug: Adalimumab;Drug: Placebo

Odense University Hospital

University of Southern Denmark;Hvidovre University Hospital;Aarhus University Hospital;AbbVie

Completed

18 Years

N/A

Both

Phase 3

Denmark

EUCTR2011-002411-29-FI
(EUCTR)

29/06/2012

11/06/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

EUCTR2011-002411-29-AT
(EUCTR)

26/06/2012

01/02/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

EUCTR2011-002411-29-PT
(EUCTR)

01/06/2012

03/01/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

EUCTR2011-002411-29-DE
(EUCTR)

11/05/2012

11/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;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

EUCTR2011-002411-29-GB
(EUCTR)

03/05/2012

07/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden

EUCTR2011-002411-29-SE
(EUCTR)

26/04/2012

13/10/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

EUCTR2011-002411-29-DK
(EUCTR)

30/03/2012

28/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden

EUCTR2011-002411-29-IE
(EUCTR)

30/03/2012

09/02/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden

EUCTR2011-002411-29-BE
(EUCTR)

07/03/2012

23/11/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

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

455

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;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

EUCTR2011-002411-29-IT
(EUCTR)

20/02/2012

07/03/2012

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB

ABBOTT GMBH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden

EUCTR2011-002411-29-GR
(EUCTR)

09/01/2012

07/12/2011

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A

Ulcerative Colitis
MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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

680

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden

EUCTR2011-004268-31-DK
(EUCTR)

13/12/2011

21/11/2011

Adalimumab (Humira) in the treatment of chronic pouchitis

Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringes
Product Name: Humira
Product Code: EMEA/H/C/000481

Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

EUCTR2007-004157-28-SE
(EUCTR)

22/10/2009

06/05/2009

Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis.

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden

EUCTR2007-004157-28-PT
(EUCTR)

17/03/2009

12/12/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;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

EUCTR2007-004157-28-NL
(EUCTR)

09/12/2008

10/12/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2007-004157-28-DE
(EUCTR)

07/08/2008

25/03/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden

EUCTR2007-004157-28-SK
(EUCTR)

04/08/2008

09/04/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden

EUCTR2007-004157-28-HU
(EUCTR)

09/07/2008

28/03/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia

EUCTR2007-004157-28-BE
(EUCTR)

23/06/2008

13/12/2007

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;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

EUCTR2007-004157-28-CZ
(EUCTR)

09/06/2008

10/04/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Ulcerative Colitis
MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

EUCTR2006-002781-20-SE
(EUCTR)

23/05/2008

04/03/2008

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

EUCTR2007-004157-28-AT
(EUCTR)

30/04/2008

08/04/2008

Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.

Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

592

Phase 3

Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden

EUCTR2006-002782-40-AT
(EUCTR)

16/03/2008

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

EUCTR2006-002781-20-AT
(EUCTR)

27/02/2008

23/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Germany;Czech Republic;Italy;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

EUCTR2006-002782-40-DE
(EUCTR)

20/02/2008

18/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria

EUCTR2006-002782-40-PT
(EUCTR)

07/09/2007

18/06/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria

EUCTR2006-002781-20-BE
(EUCTR)

16/07/2007

10/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden

EUCTR2006-002782-40-DK
(EUCTR)

09/07/2007

07/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

EUCTR2006-002781-20-DE
(EUCTR)

27/06/2007

04/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Czech Republic;Germany;Italy;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

EUCTR2006-002782-40-FR
(EUCTR)

19/06/2007

06/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

EUCTR2006-002782-40-BE
(EUCTR)

19/06/2007

05/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany

EUCTR2006-002782-40-CZ
(EUCTR)

18/06/2007

10/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

EUCTR2006-002781-20-CZ
(EUCTR)

04/05/2007

16/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

EUCTR2006-002782-40-HU
(EUCTR)

18/04/2007

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;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

EUCTR2006-002781-20-IT
(EUCTR)

17/04/2007

07/03/2007

A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND

Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: HUMIRA

Abbott GmbH Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

EUCTR2006-002781-20-HU
(EUCTR)

26/03/2007

28/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

EUCTR2006-002782-40-ES
(EUCTR)

23/03/2007

05/02/2007

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.

Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany

EUCTR2006-002781-20-SK
(EUCTR)

19/03/2007

01/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden

EUCTR2015-001346-29-SE
(EUCTR)

30/09/2015

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;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

EUCTR2015-001346-29-AT
(EUCTR)

12/01/2016

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

Phase 3

United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden

EUCTR2014-004559-29-Outside-EU/EEA
(EUCTR)

12/11/2014

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

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 Inc.

NULL

Female: yes
Male: yes

274

Japan