97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 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 | NCT04999228 (ClinicalTrials.gov) | October 1, 2021 | 5/8/2021 | Top Down Versus Step up in Pediatric Ulcerative Colitis | First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis | Ulcerative Colitis;Infliximab;Children | Drug: Infliximab;Drug: Corticosteroids | Children's Hospital of Fudan University | NULL | Not yet recruiting | 6 Years | 18 Years | All | 40 | Phase 4 | NULL |
| 2 | NCT04879966 (ClinicalTrials.gov) | May 17, 2021 | 6/5/2021 | A Cohort Study Comparing IFX to CS for Moderate to Severe UC | A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Infliximab;Drug: Corticosteroid | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 342 | China | |
| 3 | 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 | ||
| 4 | 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] | 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 | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 5 | 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 | Not Recruiting | 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 | ||
| 6 | NCT03760003 (ClinicalTrials.gov) | September 23, 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 | Completed | 18 Years | 75 Years | All | 254 | 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-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 | Not Recruiting | 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 | ||
| 8 | 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 | Not Recruiting | 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 | ||
| 9 | EUCTR2018-003558-26-IT (EUCTR) | 11/06/2019 | 22/01/2021 | 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. - 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 Name: ABX464 Product Code: [ABX464] Product Name: ABX464 Product Code: [ABX464] | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 10 | 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 | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 11 | EUCTR2018-003558-26-CZ (EUCTR) | 22/05/2019 | 14/03/2019 | 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 | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;France;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy | ||
| 12 | 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 | Not Recruiting | 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 | ||
| 13 | 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 | Germany;Belgium;Poland;Canada;Hungary;France;Italy;United Kingdom;Austria;Ukraine;Spain;Slovakia;Slovenia;Czechia;United States;Serbia;Belarus | ||
| 14 | NCT03942861 (ClinicalTrials.gov) | February 21, 2019 | 25/4/2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | NULL | Recruiting | 18 Years | 70 Years | All | 50 | Denmark | |
| 15 | NCT02921555 (ClinicalTrials.gov) | October 11, 2018 | 22/9/2016 | Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis | Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. | Ulcerative Colitis | Drug: Methylprednisolone;Drug: Prednisone | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | NULL | Recruiting | 18 Years | N/A | All | 148 | Phase 4 | Spain |
| 16 | EUCTR2017-000937-30-AT (EUCTR) | 22/02/2018 | 03/01/2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | 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 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 17 | ChiCTR2100043797 | 2018-01-01 | 2021-02-28 | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | Ulcerative colitis | Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.; | Department of Gastroenterology, Jinan Central Hospital | NULL | Completed | 21 | 81 | Both | Case series:28; | N/A | China |
| 18 | EUCTR2017-000937-30-PL (EUCTR) | 13/12/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | 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 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Belgium;Poland;Austria;Germany | ||
| 19 | EUCTR2017-000937-30-ES (EUCTR) | 27/11/2017 | 10/10/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;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 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Poland;Belgium;Spain;Austria;Germany | ||
| 20 | EUCTR2017-000937-30-FR (EUCTR) | 07/11/2017 | 19/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 21 | EUCTR2016-001170-15-ES (EUCTR) | 19/10/2017 | 02/08/2017 | Intravenous corticosteroids in moderate ulcerative colitis | Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM | Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Spain | ||
| 22 | EUCTR2017-000937-30-DE (EUCTR) | 10/10/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | 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 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 23 | NCT03093259 (ClinicalTrials.gov) | October 1, 2017 | 17/3/2017 | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids | Ulcerative Colitis | Drug: ABX464;Drug: Placebo oral capsule | Abivax S.A. | NULL | Completed | 18 Years | 70 Years | All | 32 | Phase 2 | Belgium |
| 24 | EUCTR2017-000937-30-BE (EUCTR) | 29/09/2017 | 03/08/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | 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 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 25 | 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 |
| 26 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 27 | NCT04564638 (ClinicalTrials.gov) | March 1, 2015 | 11/9/2020 | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Ulcerative Colitis | Drug: Corticosteroid | Tampere University Hospital | NULL | Completed | N/A | N/A | All | 217 | NULL | |
| 28 | NCT02033408 (ClinicalTrials.gov) | January 2014 | 3/12/2013 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | NULL | Completed | 2 Years | 75 Years | All | 28 | N/A | Canada;Finland;Israel;Italy;Poland;Spain |
| 29 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 30 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China |
| 31 | NCT01536535 (ClinicalTrials.gov) | July 10, 2012 | 16/2/2012 | Predicting Response to Standardized Pediatric Colitis Therapy | Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: Colectomy | Connecticut Children's Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 4 Years | 17 Years | All | 431 | Phase 4 | United States;Canada |
| 32 | EUCTR2009-015077-12-GB (EUCTR) | 23/11/2009 | 17/09/2009 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 33 | EUCTR2006-003607-40-BE (EUCTR) | 09/12/2008 | 27/10/2008 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml | Besancon University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 34 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 35 | NCT00498589 (ClinicalTrials.gov) | September 2007 | 9/7/2007 | Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: methotrexate;Drug: placebo | Centre Hospitalier Universitaire de Besancon | NULL | Completed | 18 Years | 75 Years | Both | 110 | Phase 2 | Austria;Belgium;France;Israel;Italy;Netherlands |
| 36 | EUCTR2006-004303-19-BE (EUCTR) | 08/06/2007 | 07/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Czech Republic;United Kingdom;Belgium | |||
| 37 | EUCTR2006-004303-19-CZ (EUCTR) | 09/05/2007 | 20/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | United Kingdom;Czech Republic;Belgium | |||
| 38 | EUCTR2006-004303-19-SK (EUCTR) | 04/05/2007 | 08/03/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 39 | EUCTR2006-004303-19-GB (EUCTR) | 25/04/2007 | 06/12/2006 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 40 | NCT00430898 (ClinicalTrials.gov) | January 2007 | 31/1/2007 | Basiliximab in Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 181 | Phase 2 | United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom |
| 41 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
| 42 | NCT00267306 (ClinicalTrials.gov) | January 2004 | 16/12/2005 | Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis | A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids | Severe Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Completed | 16 Years | 70 Years | Both | 144 | Phase 1/Phase 2 | United States |
| 43 | NCT00259545 (ClinicalTrials.gov) | February 2003 | 25/11/2005 | Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis | Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden | Ulcerative Colitis;Phosphatidylcholine | Drug: Retarded Release Phosphatidylcholine (rPC) | Heidelberg University | Professor Wolfgang Stremmel;Dietmar Hopp Stiftung | Completed | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 44 | NCT00032305 (ClinicalTrials.gov) | March 2002 | 14/3/2002 | Research Study in Patients With Severe Ulcerative Colitis | A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids | Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 2/Phase 3 | United States |