97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | 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 | JPRN-jRCT2071210030 | 19/10/2021 | 31/05/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan |
| 2 | EUCTR2020-004391-18-FR (EUCTR) | 28/10/2020 | 14/09/2020 | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ | CHU Amiens-Picardie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 3 | NCT04209556 (ClinicalTrials.gov) | June 30, 2020 | 1/12/2019 | A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 202 | Phase 2 | United States |
| 4 | EUCTR2019-002698-74-SK (EUCTR) | 26/03/2020 | 31/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 100 mg/ml Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 5 | NCT03884439 (ClinicalTrials.gov) | March 18, 2019 | 4/3/2019 | Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis) | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Crohn's Disease;Ulcerative Colitis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | NULL | Enrolling by invitation | 0 Years | N/A | All | 300 | Japan | |
| 6 | 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 |
| 7 | EUCTR2016-002707-25-IT (EUCTR) | 31/03/2017 | 13/01/2021 | n.a. | Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a. | patients with ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO INN or Proposed INN: INFLIXIMAB Trade Name: AZAFOR - 50 MG COMPRESSE RIVESTITE CON FILM 50 COMPRESSE IN BLISTER PVC/PVDC/AL INN or Proposed INN: AZATIOPRINA | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Italy | ||
| 8 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 9 | EUCTR2015-001954-14-NL (EUCTR) | 14/09/2015 | 25/08/2015 | Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial” | SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research | ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240 | Santeon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 10 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Norway | ||
| 11 | EUCTR2011-002462-20-SK (EUCTR) | 19/11/2012 | 27/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | ||||
| 12 | EUCTR2011-002462-20-PL (EUCTR) | 27/12/2011 | 20/10/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
| 13 | EUCTR2011-002462-20-HU (EUCTR) | 07/12/2011 | 22/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Hungary;Poland;Germany;Italy | ||||
| 14 | EUCTR2011-002462-20-CZ (EUCTR) | 24/11/2011 | 20/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Poland;Germany;Italy | ||||
| 15 | EUCTR2011-002462-20-DE (EUCTR) | 25/10/2011 | 13/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
| 16 | EUCTR2006-005299-42-FI (EUCTR) | 25/02/2008 | 27/12/2007 | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten INN or Proposed INN: INFLIXIMAB | Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.) | NULL | Not Recruiting | Female: yes Male: yes | 100 | France;Finland;Belgium;Spain | |||
| 17 | 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 |
| 18 | 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 |