96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2019-002942-19-DK (EUCTR) | 12/03/2021 | 05/11/2020 | Nordic study of treatment strategy in inflammatory bowel disease | NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile | Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE | Region Örebro län | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 2 | EUCTR2014-002311-41-NL (EUCTR) | 25/05/2018 | 18/12/2017 | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE | Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | France;Belgium;Germany;Netherlands;United Kingdom;Sweden | ||
| 3 | EUCTR2016-000522-18-GB (EUCTR) | 28/03/2018 | 05/12/2017 | Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. | Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL | Paediatric Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40mg/0.4ml pre-filled syringe Product Name: Humira 40mg/0.4ml pre-filled syringe INN or Proposed INN: ADALIMUMAB Other descriptive name: SUB20016 Product Name: Azathioprine INN or Proposed INN: Azathioprine Other descriptive name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methotrexate INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate Product Name: Mercaptopurine INN or Proposed INN: Mercaptopurine Other descriptive name: 6-Mercaptopurine | PIBD net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | NCT02852694 (ClinicalTrials.gov) | February 28, 2017 | 9/6/2016 | Reduce Risk for Crohn's Disease Patients | Risk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment Strategy | Crohn's Disease | Drug: Methotrexate;Drug: Adalimumab;Drug: Azathioprine / 6 Mercaptopurine | PIBD-Net | European Commission | Recruiting | 6 Years | 17 Years | All | 312 | Phase 4 | France |
| 5 | EUCTR2014-002311-41-DE (EUCTR) | 25/11/2015 | 21/08/2015 | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy - SPARE | Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | France;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 6 | EUCTR2014-002311-41-SE (EUCTR) | 21/08/2015 | 01/07/2015 | A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy | Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Imurel 25 mg Product Name: Imurel INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE Trade Name: Puri-Nethol 50 mg Product Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Metoject Product Name: Metotrexat INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 4 | France;Netherlands;Germany;United Kingdom;Sweden | ||
| 7 | EUCTR2014-002311-41-GB (EUCTR) | 14/07/2015 | 30/06/2015 | A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy (SPARE) - SPARE | Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: Remicade Product Name: INFLIXIMAB Trade Name: Imuran Product Name: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Mercaptopurine Product Name: Mercaptopurine | University of Edinburgh | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | France;Belgium;Germany;United Kingdom;Sweden | |||
| 8 | 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 |
| 9 | EUCTR2014-002311-41-FR (EUCTR) | 12/08/2014 | 22/06/2015 | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE | Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | France;United Kingdom;Sweden | |||
| 10 | NCT01629628 (ClinicalTrials.gov) | July 2012 | 19/6/2012 | Adalimumab for the Management of Post-operative Crohn's Disease (CD) | An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients | Crohn Disease | Drug: Adalimumab;Drug: 6 Mercaptopurine | Tel-Aviv Sourasky Medical Center | Abbott | Not yet recruiting | 18 Years | 70 Years | Both | 100 | Phase 3 | Israel |
| 11 | NCT01433432 (ClinicalTrials.gov) | October 2011 | 12/9/2011 | Open Label Extension Study to Protocol C2/13/DR-6MP-02 | Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study | Crohn's Disease | Drug: 80 mg DR-6MP | Teva GTC | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2 | Israel |
| 12 | NCT01094613 (ClinicalTrials.gov) | November 2010 | 25/3/2010 | Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease | MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease | Crohn's Disease | Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine | Teva GTC | NULL | Terminated | 18 Years | 75 Years | Both | 70 | Phase 1/Phase 2 | Israel |
| 13 | NCT00774982 (ClinicalTrials.gov) | December 2008 | 16/10/2008 | Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients | Pilot, Randomized, Open-Label, Two-Way Crossover Comparative Bioavailability Study of 40 mg Delayed Release Oral 6Mercaptopurine Versus 100 mg Purinethol in Patients With Crohns Disease | Crohns Disease | Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine | Teva GTC | NULL | Completed | 18 Years | 50 Years | Both | 12 | Phase 1 | Israel |
| 14 | EUCTR2006-005800-15-GB (EUCTR) | 17/09/2007 | 01/08/2007 | Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection | Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection - TOPPIC | Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 6-Mercaptopurine (Puri-Nethol) Product Name: 6-Mercaptopurine (Puri-nethol) | University of Edinburgh | NHS Lothian | Not Recruiting | Female: yes Male: yes | 234 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 15 | 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 |
| 16 | JPRN-UMIN000004427 | 2007/06/01 | 01/11/2010 | A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection | A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection - Infliximab for Crohn's Disease Patients after Intestinal Resection | Crohn's disease | Non-infliximab arm: Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum). Infliximab arm: Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial. | Lower GI disease, Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 30 | Phase 2,3 | Japan |
| 17 | NCT00287170 (ClinicalTrials.gov) | July 2006 | 2/2/2006 | Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease | Pilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD | Crohn's Disease | Drug: Delayed Release 6MP or Calcitriol vs. Purinethol | Teva GTC | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 1/Phase 2 | Israel |