97. 潰瘍性大腸炎
［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | 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 | EUCTR2018-003558-26-GB (EUCTR) | 11/02/2020 | 05/11/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 2 | EUCTR2018-003558-26-FR (EUCTR) | 10/12/2019 | 08/02/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany | |||
| 3 | EUCTR2018-003558-26-DE (EUCTR) | 30/10/2019 | 15/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 4 | EUCTR2018-003558-26-BE (EUCTR) | 29/08/2019 | 27/05/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 5 | EUCTR2018-003558-26-SI (EUCTR) | 12/06/2019 | 07/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03760003 (ClinicalTrials.gov) | June 11, 2019 | 29/11/2018 | Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment | Ulcerative Colitis | Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo | Abivax S.A. | NULL | Recruiting | 18 Years | 75 Years | All | 232 | Phase 2 | United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 7 | EUCTR2018-003558-26-SK (EUCTR) | 23/05/2019 | 20/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany | ||
| 8 | EUCTR2018-003558-26-HU (EUCTR) | 21/05/2019 | 25/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 9 | EUCTR2018-003558-26-PL (EUCTR) | 20/05/2019 | 12/04/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany | ||
| 10 | EUCTR2016-004112-35-SE (EUCTR) | 04/04/2018 | 21/06/2017 | A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel disease | Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study | Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imurel Product Name: Azathioprine Product Code: NA Trade Name: Allopurinol Product Name: Allopurinol Product Code: NA | SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | JPRN-UMIN000030988 | 2018/02/01 | 01/02/2018 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Ulcerative Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | NULL | Pending | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan | |
| 12 | NCT03151525 (ClinicalTrials.gov) | May 8, 2017 | 8/5/2017 | Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis | Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab | Colitis, Ulcerative | Drug: Azathioprine;Drug: Infliximab | Istituto Clinico Humanitas | Agenzia Italiana del Farmaco | Recruiting | 18 Years | 65 Years | All | 100 | Phase 4 | Italy |
| 13 | NCT03101800 (ClinicalTrials.gov) | December 14, 2016 | 27/1/2017 | Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis | Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial | Colitis, Ulcerative;Colitis Ulcerative Exacerbation | Drug: Azathioprine and Allopurinol;Drug: Azathioprine | Hvidovre University Hospital | Aalborg University Hospital;Zealand University Hospital;University of Copenhagen;Odense University Hospital;Aarhus University Hospital;Regional Hospital Viborg;Vejle Hospital;Sydvestjysk Hospital Esbjerg | Unknown status | 18 Years | 80 Years | All | 84 | Phase 3 | Denmark |
| 14 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 15 | EUCTR2016-002433-30-DK (EUCTR) | 25/08/2016 | 21/06/2016 | Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis | Low-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC | 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: Imurel INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Allopurinol INN or Proposed INN: ALLOPURINOL | Hvidovre Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 3 | Denmark | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02579733 (ClinicalTrials.gov) | February 1, 2016 | 16/10/2015 | Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Placebo | Kyungpook National University Hospital | Celltrion | Terminated | 18 Years | 80 Years | All | 16 | Phase 4 | Korea, Republic of | |
| 17 | NCT02413047 (ClinicalTrials.gov) | May 2015 | 6/3/2015 | Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator | A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate | Indiana University | NULL | Terminated | 18 Years | 80 Years | All | 3 | N/A | United States |
| 18 | EUCTR2012-001653-13-IT (EUCTR) | 10/07/2013 | 27/03/2013 | New Therapeutic Strategy in Ulcerative Colitis | New Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in PediatricPatients | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AZAFOR 50mg Product Name: AZATIOPRINA Product Code: AZA INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE | Dipartimento di Pediatria Università Federico II di Napoli | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Italy | |||
| 19 | JPRN-UMIN000006141 | 2011/10/01 | 12/08/2011 | Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis | ulcerative colitis | Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54). Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54). | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | |
| 20 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. | Ulcerative colitis | 5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule. | Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT00984568 (ClinicalTrials.gov) | November 2009 | 24/9/2009 | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553) | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study | Colitis, Ulcerative | Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 3 | Germany |
| 22 | EUCTR2009-010065-23-DE (EUCTR) | 17/08/2009 | 14/04/2009 | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone | Essex Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 23 | EUCTR2006-002670-22-GB (EUCTR) | 11/06/2008 | 01/08/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 24 | EUCTR2006-002670-22-SK (EUCTR) | 08/02/2008 | 15/04/2008 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 25 | EUCTR2006-002670-22-IT (EUCTR) | 27/11/2007 | 04/10/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: Infliximab Trade Name: imuran INN or Proposed INN: azathioprine | SCHERING-PLOUGH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2006-002670-22-DE (EUCTR) | 31/10/2007 | 12/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 27 | EUCTR2006-002670-22-PT (EUCTR) | 12/10/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 28 | EUCTR2006-002670-22-ES (EUCTR) | 20/09/2007 | 26/07/2007 | Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). | Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). | Colitis Ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 29 | EUCTR2006-002670-22-FR (EUCTR) | 07/09/2007 | 14/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 30 | NCT00521950 (ClinicalTrials.gov) | September 2007 | 27/8/2007 | Cost-effectiveness of TPMT Pharmacogenetics | Pharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System. | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Genetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP) | ZonMw: The Netherlands Organisation for Health Research and Development | Radboud University | Completed | 18 Years | N/A | Both | 853 | N/A | 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 | EUCTR2006-002670-22-CZ (EUCTR) | 29/08/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy | |||
| 32 | EUCTR2006-002670-22-HU (EUCTR) | 09/08/2007 | 04/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 33 | EUCTR2006-002670-22-BE (EUCTR) | 25/07/2007 | 15/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 34 | NCT00537316 (ClinicalTrials.gov) | July 2007 | 28/9/2007 | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Ulcerative Colitis | Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion | Merck Sharp & Dohme Corp. | NULL | Terminated | 21 Years | N/A | All | 242 | Phase 3 | Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 35 | EUCTR2005-000695-40-GB (EUCTR) | 27/09/2005 | 17/08/2005 | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | The medical condition is Ulcerative Colitis. | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 4 | United Kingdom |