DDrare: Database of Drug Development for Rare Diseases

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	NCT04156984 (ClinicalTrials.gov)	May 2020	24/10/2019	Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis	Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens	Ulcerative Colitis	Drug: Golimumab Prefilled Syringe	David Drobne	NULL	Not yet recruiting	18 Years	65 Years	All	30	Phase 4	Slovenia
2	EUCTR2019-003987-37-SI (EUCTR)	26/02/2020	27/11/2019	Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis	Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		University Medical Centre Ljubljana, Department of gastroenterology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Slovenia
3	EUCTR2017-004496-31-NL (EUCTR)	20/09/2019	27/09/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	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]		Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
4	NCT03885713 (ClinicalTrials.gov)	September 10, 2019	4/3/2019	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	180	Phase 4	Spain
5	EUCTR2018-001510-15-DE (EUCTR)	02/05/2019	19/11/2018	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	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: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA ® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi ® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;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
6	NCT03773445 (ClinicalTrials.gov)	March 1, 2019	25/11/2018	Golimumab Trough Levels in Patients With Ulcerative Colitis	Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis	Ulcerative Colitis	Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy	Hospital San Carlos, Madrid	Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp.	Recruiting	18 Years	N/A	All	100		Spain
7	EUCTR2018-001510-15-PL (EUCTR)	01/03/2019	04/02/2019	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	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]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany
8	EUCTR2017-004496-31-PL (EUCTR)	30/01/2019	06/12/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	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: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of
9	EUCTR2017-004496-31-FR (EUCTR)	17/12/2018	14/09/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	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]		Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
10	NCT03662542 (ClinicalTrials.gov)	November 20, 2018	6/9/2018	A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	65 Years	All	210	Phase 2	United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-004496-31-BE (EUCTR)	07/11/2018	25/07/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	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: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of
12	NCT03596645 (ClinicalTrials.gov)	October 29, 2018	13/7/2018	A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab;Drug: Infliximab	Janssen Research & Development, LLC	NULL	Recruiting	2 Years	17 Years	All	125	Phase 3	United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan
13	EUCTR2017-004496-31-ES (EUCTR)	15/10/2018	28/08/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	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: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
14	NCT03669029 (ClinicalTrials.gov)	October 1, 2018	4/7/2018	Optimization of Golimumab Treatment in Ulcerative Colitis	Optimization of Golimumab Treatment in Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.	Hospital de Manises	Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.	Unknown status	18 Years	80 Years	All	50	Phase 4	Spain
15	NCT03394586 (ClinicalTrials.gov)	January 1, 2018	28/12/2017	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab	Ulcerative Colitis;Flare Up, Symptom	Drug: Exposure to golimumab	University of Zurich	NULL	Unknown status	N/A	N/A	All	100		Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT03182166 (ClinicalTrials.gov)	November 21, 2017	29/5/2017	Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization	Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization	Ulcerative Colitis	Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples	Centre Hospitalier Universitaire de Saint Etienne	Merck Sharp & Dohme Corp.	Recruiting	18 Years	N/A	All	80	Phase 2	France
17	NCT03124121 (ClinicalTrials.gov)	September 5, 2017	4/4/2017	Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Ulcerative Colitis	Drug: Golimumab	Guy's and St Thomas' NHS Foundation Trust	Merck Sharp & Dohme Corp.	Completed	18 Years	N/A	All	112	Phase 4	United Kingdom
18	EUCTR2017-001374-42-GB (EUCTR)	21/07/2017	19/07/2017	Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis	Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL	Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Guy's and St Thomas' NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112	Phase 4	United Kingdom
19	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
20	NCT02425865 (ClinicalTrials.gov)	December 2016	21/4/2015	Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET	Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET	ULCERATIVE COLITIS	Drug: GOLIMUMAB	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Recruiting	18 Years	75 Years	All	200	Phase 4	Belgium;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT03018925 (ClinicalTrials.gov)	October 2016	13/12/2016	Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis	Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study	Ulcerative Colitis	Drug: Golimumab	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	NULL	Recruiting	18 Years	N/A	All	15	N/A	Spain
22	NCT02687724 (ClinicalTrials.gov)	June 2016	16/2/2016	Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis	GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC).	Colitis	Drug: Golimumab (GLM)	University College Dublin	NULL	Unknown status	18 Years	N/A	All	136	Phase 4	Ireland
23	EUCTR2015-004724-62-IE (EUCTR)	22/12/2015	05/11/2015	Golimumab dose variation to achieve response in Colitis	Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC)	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: Simponi Product Name: Simponi INN or Proposed INN: GOLIMUMAB INN or Proposed INN: GOLIMUMAB	UCD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	136	Phase 4	Ireland
24	EUCTR2014-002579-27-IT (EUCTR)	03/03/2015	19/01/2015	Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone	Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL	active steroid-dependent 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: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB	Istituto Clinico Humanitas	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Italy
25	NCT02412085 (ClinicalTrials.gov)	March 2015	26/3/2015	Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission	Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab	Istituto Clinico Humanitas	NULL	Recruiting	18 Years	65 Years	Both	100	Phase 4	Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT02318667 (ClinicalTrials.gov)	February 27, 2015	12/12/2014	Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).	An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab.	Colitis, Ulcerative	Biological: Golimumab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	65 Years	All	38	Phase 4	Portugal
27	EUCTR2013-002042-36-FR (EUCTR)	04/02/2015	22/06/2015	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
28	EUCTR2014-003262-25-PT (EUCTR)	12/12/2014	20/11/2014	Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab	An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	37	Phase 4	Portugal
29	EUCTR2013-002042-36-NL (EUCTR)	24/09/2014	13/06/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany
30	EUCTR2013-002042-36-BG (EUCTR)	11/09/2014	30/04/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2013-002042-36-DE (EUCTR)	31/07/2014	27/05/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
32	EUCTR2013-002042-36-BE (EUCTR)	10/07/2014	20/02/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
33	NCT02155335 (ClinicalTrials.gov)	July 1, 2014	2/6/2014	Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)	Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	100	Phase 4	Belgium
34	EUCTR2014-000656-29-BE (EUCTR)	13/06/2014	05/03/2014	Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device	Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Simponi ® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi ® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi	MSD Belgium BVBA/SPRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
35	EUCTR2013-002042-36-PL (EUCTR)	09/06/2014	06/05/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2013-002042-36-CZ (EUCTR)	04/06/2014	21/03/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
37	NCT02186886 (ClinicalTrials.gov)	June 2014	1/7/2014	Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab	Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)	Ulcerative Colitis	Drug: Golimumab	Kliniken im Naturpark Altmuehltal	NULL	Recruiting	18 Years	N/A	Both	50	Phase 4	Germany
38	EUCTR2013-002042-36-HU (EUCTR)	12/05/2014	21/02/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2a	United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany
39	NCT02092285 (ClinicalTrials.gov)	May 9, 2014	18/3/2014	Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)	Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis	Ulcerative Colitis	Drug: Golimumab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	205	Phase 4	United Kingdom
40	EUCTR2013-004583-56-GB (EUCTR)	28/01/2014	23/12/2013	Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis	Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab	MSD	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2012-004366-18-BE (EUCTR)	08/01/2014	27/06/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1b	United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany
42	EUCTR2012-004366-18-DE (EUCTR)	17/12/2013	29/07/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 1	United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany
43	EUCTR2012-004366-18-DK (EUCTR)	11/12/2013	03/12/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 1	United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands
44	NCT01988961 (ClinicalTrials.gov)	December 2013	14/11/2013	A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Biological: Golimumab	Janssen Research & Development, LLC	NULL	Completed	18 Years	N/A	All	103	Phase 2	United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine
45	EUCTR2012-004366-18-NL (EUCTR)	28/11/2013	16/08/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1b	France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	NCT01900574 (ClinicalTrials.gov)	August 9, 2013	12/7/2013	A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab	Janssen Research & Development, LLC	NULL	Active, not recruiting	2 Years	17 Years	All	35	Phase 1	United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland
47	EUCTR2012-004366-18-AT (EUCTR)	30/07/2013	12/06/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1	United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany
48	NCT01804166 (ClinicalTrials.gov)	March 21, 2013	1/2/2013	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	Hepatosplenic T-Cell Lymphoma	Drug: Infliximab;Drug: Golimumab	Janssen Scientific Affairs, LLC	NULL	Completed	N/A	N/A	All	1	Phase 4	United States
49	NCT01863771 (ClinicalTrials.gov)	March 15, 2013	23/5/2013	A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.	A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab;Other: Placebo	Janssen Pharmaceutical K.K.	NULL	Completed	18 Years	70 Years	All	144	Phase 3	Japan
50	EUCTR2006-003398-28-CZ (EUCTR)	24/05/2010	10/02/2010	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2006-003399-37-CZ (EUCTR)	24/05/2010	10/02/2010	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden
52	JPRN-JapicCTI-090739	08/12/2008	10/04/2009	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Intervention name : golimumab Dosage And administration of the intervention : SC	JANSSEN PHARMACEUTICAL K.K	NULL		18		BOTH		Phase 2;Phase 3	NULL
53	JPRN-JapicCTI-090740	08/12/2008	10/04/2009	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Intervention name : golimumab Dosage And administration of the intervention : SC	JANSSEN PHARMACEUTICAL K.K	NULL		18		BOTH		Phase 3	NULL
54	EUCTR2006-003397-94-SE (EUCTR)	23/10/2008	21/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden
55	EUCTR2006-003399-37-DK (EUCTR)	25/09/2008	10/12/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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
56	EUCTR2006-003398-28-DK (EUCTR)	25/09/2008	04/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
57	EUCTR2006-003398-28-SE (EUCTR)	26/08/2008	21/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden
58	EUCTR2006-003399-37-SE (EUCTR)	26/08/2008	21/12/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
59	EUCTR2006-003398-28-BG (EUCTR)	10/06/2008	30/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania
60	EUCTR2006-003397-94-BG (EUCTR)	30/05/2008	30/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2006-003399-37-BG (EUCTR)	30/05/2008	30/04/2008	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden
62	EUCTR2006-003398-28-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
63	EUCTR2006-003397-94-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
64	EUCTR2006-003399-37-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
65	EUCTR2006-003399-37-NL (EUCTR)	17/01/2008	08/10/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics BV	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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
66	EUCTR2006-003398-28-NL (EUCTR)	17/01/2008	08/10/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
67	EUCTR2006-003397-94-NL (EUCTR)	17/01/2008	07/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
68	EUCTR2006-003398-28-BE (EUCTR)	10/12/2007	18/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
69	EUCTR2006-003399-37-DE (EUCTR)	27/11/2007	03/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
70	EUCTR2006-003397-94-AT (EUCTR)	15/11/2007	16/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2006-003398-28-DE (EUCTR)	15/11/2007	03/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
72	EUCTR2006-003399-37-BE (EUCTR)	15/11/2007	18/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden
73	EUCTR2006-003397-94-BE (EUCTR)	15/11/2007	18/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
74	EUCTR2006-003399-37-HU (EUCTR)	30/10/2007	10/07/2007	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden
75	EUCTR2006-003397-94-HU (EUCTR)	30/10/2007	10/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2006-003398-28-HU (EUCTR)	29/10/2007	10/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
77	EUCTR2006-003399-37-SK (EUCTR)	04/10/2007	23/12/2009	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics BV	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
78	EUCTR2006-003397-94-SK (EUCTR)	04/10/2007	16/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden
79	EUCTR2006-003398-28-SK (EUCTR)	04/10/2007	23/12/2009	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
80	EUCTR2006-003399-37-AT (EUCTR)	27/09/2007	17/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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	EUCTR2006-003399-37-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
82	EUCTR2006-003398-28-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
83	EUCTR2006-003397-94-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
84	EUCTR2006-003398-28-AT (EUCTR)	06/09/2007	17/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
85	EUCTR2006-003397-94-DE (EUCTR)	05/09/2007	03/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2006-003397-94-LV (EUCTR)	03/09/2007	04/09/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
87	EUCTR2006-003398-28-LV (EUCTR)	03/09/2007	04/09/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
88	EUCTR2006-003399-37-LV (EUCTR)	03/09/2007	04/09/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan
89	NCT00488631 (ClinicalTrials.gov)	September 2007	18/6/2007	An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg	Janssen Research & Development, LLC	Merck Sharp & Dohme Corp.	Completed	18 Years	N/A	All	1228	Phase 3	United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom
90	NCT00488774 (ClinicalTrials.gov)	August 2007	18/6/2007	An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg	Janssen Research & Development, LLC	Merck Sharp & Dohme Corp.	Terminated	18 Years	N/A	All	291	Phase 2;Phase 3	United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT00487539 (ClinicalTrials.gov)	August 2007	14/6/2007	An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg	Janssen Research & Development, LLC	Merck Sharp & Dohme Corp.	Completed	18 Years	N/A	All	1065	Phase 2;Phase 3	United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom
92	EUCTR2012-004366-18-FR (EUCTR)		28/09/2015	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	NA			Female: yes Male: yes	30	Phase 1	United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04156984
(ClinicalTrials.gov)

May 2020

24/10/2019

Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens

Ulcerative Colitis

Drug: Golimumab Prefilled Syringe

David Drobne

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 4

Slovenia

EUCTR2019-003987-37-SI
(EUCTR)

26/02/2020

27/11/2019

Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens

Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

University Medical Centre Ljubljana, Department of gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Slovenia

EUCTR2017-004496-31-NL
(EUCTR)

20/09/2019

27/09/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

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]

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

NCT03885713
(ClinicalTrials.gov)

September 10, 2019

4/3/2019

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

180

Phase 4

Spain

EUCTR2018-001510-15-DE
(EUCTR)

02/05/2019

19/11/2018

A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA

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: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA ®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi ®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;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

NCT03773445
(ClinicalTrials.gov)

March 1, 2019

25/11/2018

Golimumab Trough Levels in Patients With Ulcerative Colitis

Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis

Ulcerative Colitis

Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy

Hospital San Carlos, Madrid

Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp.

Recruiting

18 Years

N/A

All

100

Spain

EUCTR2018-001510-15-PL
(EUCTR)

01/03/2019

04/02/2019

A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany

EUCTR2017-004496-31-PL
(EUCTR)

30/01/2019

06/12/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants 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: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of

EUCTR2017-004496-31-FR
(EUCTR)

17/12/2018

14/09/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

NCT03662542
(ClinicalTrials.gov)

November 20, 2018

6/9/2018

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

65 Years

All

210

Phase 2

United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-004496-31-BE
(EUCTR)

07/11/2018

25/07/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

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: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of

NCT03596645
(ClinicalTrials.gov)

October 29, 2018

13/7/2018

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab;Drug: Infliximab

Janssen Research & Development, LLC

NULL

Recruiting

2 Years

17 Years

All

125

Phase 3

United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan

EUCTR2017-004496-31-ES
(EUCTR)

15/10/2018

28/08/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

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]

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

NCT03669029
(ClinicalTrials.gov)

October 1, 2018

4/7/2018

Optimization of Golimumab Treatment in Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization.

Hospital de Manises

Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp.

Unknown status

18 Years

80 Years

All

Phase 4

Spain

NCT03394586
(ClinicalTrials.gov)

January 1, 2018

28/12/2017

Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

Ulcerative Colitis;Flare Up, Symptom

Drug: Exposure to golimumab

University of Zurich

NULL

Unknown status

N/A

All

100

Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03182166
(ClinicalTrials.gov)

November 21, 2017

29/5/2017

Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

Ulcerative Colitis

Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples

Centre Hospitalier Universitaire de Saint Etienne

Merck Sharp & Dohme Corp.

Recruiting

18 Years

N/A

All

Phase 2

France

NCT03124121
(ClinicalTrials.gov)

September 5, 2017

4/4/2017

Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

Ulcerative Colitis

Drug: Golimumab

Guy's and St Thomas' NHS Foundation Trust

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

112

Phase 4

United Kingdom

EUCTR2017-001374-42-GB
(EUCTR)

21/07/2017

19/07/2017

Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis

Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL

Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Guy's and St Thomas' NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Phase 4

United Kingdom

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

NCT02425865
(ClinicalTrials.gov)

December 2016

21/4/2015

Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET

Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET

ULCERATIVE COLITIS

Drug: GOLIMUMAB

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Recruiting

18 Years

75 Years

All

200

Phase 4

Belgium;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03018925
(ClinicalTrials.gov)

October 2016

13/12/2016

Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis

Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study

Ulcerative Colitis

Drug: Golimumab

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

NULL

Recruiting

18 Years

N/A

All

N/A

Spain

NCT02687724
(ClinicalTrials.gov)

June 2016

16/2/2016

Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis

GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC).

Colitis

Drug: Golimumab (GLM)

University College Dublin

NULL

Unknown status

18 Years

N/A

All

136

Phase 4

Ireland

EUCTR2015-004724-62-IE
(EUCTR)

22/12/2015

05/11/2015

Golimumab dose variation to achieve response in Colitis

Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC)

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: Simponi
Product Name: Simponi
INN or Proposed INN: GOLIMUMAB
INN or Proposed INN: GOLIMUMAB

UCD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Phase 4

Ireland

EUCTR2014-002579-27-IT
(EUCTR)

03/03/2015

19/01/2015

Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone

Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL

active steroid-dependent 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: SIMPONI
Product Name: SIMPONI
Product Code: NA
INN or Proposed INN: GOLIMUMAB

Istituto Clinico Humanitas

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Italy

NCT02412085
(ClinicalTrials.gov)

March 2015

26/3/2015

Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab

Istituto Clinico Humanitas

NULL

Recruiting

18 Years

65 Years

Both

100

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02318667
(ClinicalTrials.gov)

February 27, 2015

12/12/2014

Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab.

Colitis, Ulcerative

Biological: Golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

All

Phase 4

Portugal

EUCTR2013-002042-36-FR
(EUCTR)

04/02/2015

22/06/2015

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

EUCTR2014-003262-25-PT
(EUCTR)

12/12/2014

20/11/2014

Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab

An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal

EUCTR2013-002042-36-NL
(EUCTR)

24/09/2014

13/06/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany

EUCTR2013-002042-36-BG
(EUCTR)

11/09/2014

30/04/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-002042-36-DE
(EUCTR)

31/07/2014

27/05/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

EUCTR2013-002042-36-BE
(EUCTR)

10/07/2014

20/02/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

NCT02155335
(ClinicalTrials.gov)

July 1, 2014

2/6/2014

Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

100

Phase 4

Belgium

EUCTR2014-000656-29-BE
(EUCTR)

13/06/2014

05/03/2014

Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device

Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Simponi ® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi
Trade Name: Simponi ® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi

MSD Belgium BVBA/SPRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

EUCTR2013-002042-36-PL
(EUCTR)

09/06/2014

06/05/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-002042-36-CZ
(EUCTR)

04/06/2014

21/03/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands

NCT02186886
(ClinicalTrials.gov)

June 2014

1/7/2014

Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab

Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)

Ulcerative Colitis

Drug: Golimumab

Kliniken im Naturpark Altmuehltal

NULL

Recruiting

18 Years

N/A

Both

Phase 4

Germany

EUCTR2013-002042-36-HU
(EUCTR)

12/05/2014

21/02/2014

A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2a

United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany

NCT02092285
(ClinicalTrials.gov)

May 9, 2014

18/3/2014

Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)

Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis

Ulcerative Colitis

Drug: Golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

205

Phase 4

United Kingdom

EUCTR2013-004583-56-GB
(EUCTR)

28/01/2014

23/12/2013

Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis

Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
Product Name: Simponi
INN or Proposed INN: golimumab

MSD

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-004366-18-BE
(EUCTR)

08/01/2014

27/06/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK

Ulcerative Colitis in pediatric subjects
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1b

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

EUCTR2012-004366-18-DE
(EUCTR)

17/12/2013

29/07/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany

EUCTR2012-004366-18-DK
(EUCTR)

11/12/2013

03/12/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands

NCT01988961
(ClinicalTrials.gov)

December 2013

14/11/2013

A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Golimumab

Janssen Research & Development, LLC

NULL

Completed

18 Years

N/A

All

103

Phase 2

United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine

EUCTR2012-004366-18-NL
(EUCTR)

28/11/2013

16/08/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1b

France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01900574
(ClinicalTrials.gov)

August 9, 2013

12/7/2013

A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab

Janssen Research & Development, LLC

NULL

Active, not recruiting

2 Years

17 Years

All

Phase 1

United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland

EUCTR2012-004366-18-AT
(EUCTR)

30/07/2013

12/06/2013

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany

NCT01804166
(ClinicalTrials.gov)

March 21, 2013

1/2/2013

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Hepatosplenic T-Cell Lymphoma

Drug: Infliximab;Drug: Golimumab

Janssen Scientific Affairs, LLC

NULL

Completed

N/A

All

Phase 4

United States

NCT01863771
(ClinicalTrials.gov)

March 15, 2013

23/5/2013

A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab;Other: Placebo

Janssen Pharmaceutical K.K.

NULL

Completed

18 Years

70 Years

All

144

Phase 3

Japan

EUCTR2006-003398-28-CZ
(EUCTR)

24/05/2010

10/02/2010

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-003399-37-CZ
(EUCTR)

24/05/2010

10/02/2010

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden

JPRN-JapicCTI-090739

08/12/2008

10/04/2009

Ulcerative Colitis

Intervention name : golimumab
Dosage And administration of the intervention : SC

JANSSEN PHARMACEUTICAL K.K

NULL

BOTH

Phase 2;Phase 3

NULL

JPRN-JapicCTI-090740

08/12/2008

10/04/2009

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Intervention name : golimumab
Dosage And administration of the intervention : SC

JANSSEN PHARMACEUTICAL K.K

NULL

BOTH

Phase 3

NULL

EUCTR2006-003397-94-SE
(EUCTR)

23/10/2008

21/12/2007

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

EUCTR2006-003399-37-DK
(EUCTR)

25/09/2008

10/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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

EUCTR2006-003398-28-DK
(EUCTR)

25/09/2008

04/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003398-28-SE
(EUCTR)

26/08/2008

21/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

EUCTR2006-003399-37-SE
(EUCTR)

26/08/2008

21/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Ulcerative Colitis (UC)
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2006-003398-28-BG
(EUCTR)

10/06/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003397-94-BG
(EUCTR)

30/05/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-003399-37-BG
(EUCTR)

30/05/2008

30/04/2008

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden

EUCTR2006-003398-28-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003397-94-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-NL
(EUCTR)

17/01/2008

08/10/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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

EUCTR2006-003398-28-NL
(EUCTR)

17/01/2008

08/10/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003397-94-NL
(EUCTR)

17/01/2008

07/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003398-28-BE
(EUCTR)

10/12/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-DE
(EUCTR)

27/11/2007

03/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

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

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2006-003397-94-AT
(EUCTR)

15/11/2007

16/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-003398-28-DE
(EUCTR)

15/11/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-BE
(EUCTR)

15/11/2007

18/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

EUCTR2006-003397-94-BE
(EUCTR)

15/11/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-HU
(EUCTR)

30/10/2007

10/07/2007

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden

EUCTR2006-003397-94-HU
(EUCTR)

30/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-003398-28-HU
(EUCTR)

29/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-SK
(EUCTR)

04/10/2007

23/12/2009

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

EUCTR2006-003397-94-SK
(EUCTR)

04/10/2007

16/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden

EUCTR2006-003398-28-SK
(EUCTR)

04/10/2007

23/12/2009

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

EUCTR2006-003399-37-AT
(EUCTR)

27/09/2007

17/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Ulcerative Colitis (UC)
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;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

EUCTR2006-003399-37-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003398-28-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003397-94-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003398-28-AT
(EUCTR)

06/09/2007

17/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003397-94-DE
(EUCTR)

05/09/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-003397-94-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003398-28-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

EUCTR2006-003399-37-LV
(EUCTR)

03/09/2007

04/09/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan

NCT00488631
(ClinicalTrials.gov)

September 2007

18/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1228

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom

NCT00488774
(ClinicalTrials.gov)

August 2007

18/6/2007

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Terminated

18 Years

N/A

All

291

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00487539
(ClinicalTrials.gov)

August 2007

14/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1065

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom

EUCTR2012-004366-18-FR
(EUCTR)

28/09/2015

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis in pediatric subjects
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Female: yes
Male: yes

Phase 1

United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany