96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | NCT05040464 (ClinicalTrials.gov) | August 26, 2021 | 26/8/2021 | Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial | Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial | Crohn Disease;Azathioprine;Methotrexate | Drug: AZA capsules;Drug: MTX;Biological: blood sample | Centre Hospitalier Universitaire, Amiens | NULL | Recruiting | 18 Years | N/A | All | 166 | Phase 3 | France |
| 2 | 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 | ||
| 3 | NCT04761952 (ClinicalTrials.gov) | February 13, 2021 | 14/2/2021 | N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease | N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease:a Prospective Randomized Controlled Trial | Inflammatory Bowel Diseases;Crohn Disease;Polyunsaturated Acid Lipidosis | Drug: azathioprine;Drug: infliximab;Drug: N-3 Polyunsaturated Fatty Acids | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Not yet recruiting | 18 Years | 80 Years | All | 236 | N/A | NULL |
| 4 | NCT04713631 (ClinicalTrials.gov) | January 2021 | 3/12/2020 | Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease | Phase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety, Efficacy of Artesunate & Curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of Azathioprine | Crohn's Disease | Drug: Artesunate;Drug: Curcumin;Drug: Placebo A;Drug: Placebo C | Sanjay Gandhi Postgraduate Institute of Medical Sciences | St George's University of London, London, UK | Not yet recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | India |
| 5 | NCT03681652 (ClinicalTrials.gov) | February 11, 2019 | 20/9/2018 | Post-Operative Crohn's Disease Outcome in Children | Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study | Crohn Disease | Drug: Azathioprine;Drug: Anti-TNF Drug | Schneider Children's Medical Center, Israel | NULL | Recruiting | 6 Years | 18 Years | All | 100 | Israel | |
| 6 | 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 | ||
| 7 | NCT04160325 (ClinicalTrials.gov) | May 14, 2018 | 3/11/2019 | Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery | The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery | Crohn Disease | Dietary Supplement: postoperative 3-month exclusive enteral nutrition;Drug: azathioprine;Other: normal diet | Zhu Weiming | Sixth Affiliated Hospital, Sun Yat-sen University;Sir Run Run Shaw Hospital;The First Affiliated Hospital of Anhui Medical University;Beijing Tsinghua Changgung Hospital | Recruiting | 18 Years | 65 Years | All | 198 | N/A | China |
| 8 | EUCTR2016-000522-18-BE (EUCTR) | 02/05/2018 | 08/01/2018 | Risk stratified randomized 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 randomized 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 | Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: humira INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Methotrexate Product Name: methotrexate | PIBDNet | 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;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2016-000522-18-CZ (EUCTR) | 24/04/2018 | 25/04/2018 | Risk stratified randomized 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 randomized 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-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 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 | ||
| 11 | 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 | ||
| 12 | EUCTR2016-000522-18-NL (EUCTR) | 28/12/2017 | 03/07/2017 | Risk stratified randomized 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 randomized 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 | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: humira INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine Product Name: imuran INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: methotrexate Product Name: methotrexate Product Code: L01BA INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Not Recruiting | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 13 | NCT03393247 (ClinicalTrials.gov) | June 1, 2017 | 8/7/2017 | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study | Crohn Disease | Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14 | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Unknown status | 14 Years | 60 Years | All | 160 | N/A | China |
| 14 | NCT03185611 (ClinicalTrials.gov) | May 18, 2017 | 11/6/2017 | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial | Crohn Disease | Drug: Rifaximin;Drug: Azathioprine | Sixth Affiliated Hospital, Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw Hospital | Recruiting | 18 Years | 65 Years | All | 120 | Phase 3 | China |
| 15 | 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 |
| 16 | EUCTR2016-000522-18-IT (EUCTR) | 24/02/2017 | 08/06/2021 | Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease. | Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL | Crohn Disease MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML Product Name: Methotrexate Product Code: N.A Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: N.A Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE Product Name: Azatioprina Product Code: N.A Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE Product Name: Purinethol | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2016-000522-18-DE (EUCTR) | 05/01/2017 | 01/08/2016 | Risk stratified randomized 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 randomized 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-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Product Name: Methotrexat INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBD-Net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 3 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 18 | NCT02998827 (ClinicalTrials.gov) | November 2016 | 24/11/2016 | Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients | Crohn Disease | Drug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutrition | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Enrolling by invitation | N/A | N/A | Female | 90 | N/A | NULL | |
| 19 | ChiCTR-IIR-16007751 | 2016-01-01 | 2016-01-13 | Clinical study of acupuncture and moxibustion treatment for Cohn's disease | Molecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease | Crohn's disease | Acupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine; | Shanghai Research Institute of Acupuncture and Meridian | NULL | Recruiting | 16 | 70 | Both | Acupuncture Group:40;Placebo acupuncture group:40;Drug Group:40; | I (Phase 1 study) | China |
| 20 | ChiCTR1800020305 | 2016-01-01 | 2018-12-23 | A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease | Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI | crohn's disease;K50.900 | Group 2:infliximab + azathioprine;Group 1:infliximab alone; | Department of Gastroenterology, Nanfang Hospital, Southern Medical University | NULL | Recruiting | 12 | 80 | Both | Group 2:41;Group 1:45; | China | |
| 21 | 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 | ||
| 22 | NCT02177071 (ClinicalTrials.gov) | October 9, 2015 | 26/6/2014 | 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 | Crohn's Disease | Drug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: Methotrexate | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Saint-Louis Hospital, Paris, France | Active, not recruiting | 18 Years | 65 Years | All | 211 | Phase 4 | Australia;Belgium;France |
| 23 | 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 | ||
| 24 | 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 | |||
| 25 | EUCTR2010-020137-10-LT (EUCTR) | 13/05/2015 | 12/03/2015 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 26 | 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 |
| 27 | NCT02517684 (ClinicalTrials.gov) | April 2015 | 1/7/2015 | Top-down Infliximab Study in Kids With Crohn's Disease | Top-down Infliximab Study in Kids With Crohn's Disease | Crohn's Disease | Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine | Erasmus Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer | Active, not recruiting | 3 Years | 17 Years | All | 100 | Phase 4 | Belgium;Finland;Netherlands;Denmark;Italy;Poland |
| 28 | NCT02332356 (ClinicalTrials.gov) | September 2014 | 4/1/2015 | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Crohn Disease | Drug: azathioprine or adalimumab and infliximab | Tokyo Medical and Dental University | NULL | Recruiting | 16 Years | 65 Years | All | 100 | Phase 3 | Japan |
| 29 | 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 | |||
| 30 | EUCTR2013-001503-37-DK (EUCTR) | 31/05/2013 | 06/05/2013 | Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease | Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease | Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease) MedDRA version: 14.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;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 Other descriptive name: ALLOPURINOL SODIUM | Marianne Kiszka-Kanowitz | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 3 | Denmark | ||
| 31 | JPRN-UMIN000010524 | 2013/03/29 | 17/04/2013 | Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy | Crohn's disease | Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician. | Tokyo Medical & Dental University Gastroenterology | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 32 | NCT01817972 (ClinicalTrials.gov) | March 2013 | 19/3/2013 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Certolizumab pegol;Drug: Azathioprine | Gastroenterology Research of America | UCB Pharma | Not yet recruiting | 18 Years | 70 Years | Both | 65 | Phase 3 | United States |
| 33 | NCT01802593 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure | Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure | Crohn's Disease | Drug: AZATHIOPRINE or METHOTREXATE | Prof. Arie Levine | NULL | Terminated | 6 Years | 18 Years | Both | 20 | Phase 4 | Israel |
| 34 | JPRN-UMIN000009596 | 2013/01/01 | 21/12/2012 | Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). | Crohn`s disease | Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. | Department of Internal Medicine, School of Medicine, Keio University | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 200 | Not selected | Japan | |
| 35 | NCT01880307 (ClinicalTrials.gov) | January 2013 | 7/6/2013 | Infliximab Top-down in Pediatric Crohn | Infliximab Top-down Study in Kids With Crohn's Disease | Crohn's Disease | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolon | Erasmus Medical Center | University of Roma La Sapienza;University Hospital, Brussels | Terminated | 3 Years | 17 Years | Both | 13 | Phase 4 | Italy;Netherlands |
| 36 | NCT01823042 (ClinicalTrials.gov) | October 2012 | 25/3/2013 | The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD) | A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD). | Crohn's Disease | Drug: azathioprine+enteral nutrition;Drug: Azathioprine | Jinling Hospital, China | NULL | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China |
| 37 | NCT01564823 (ClinicalTrials.gov) | June 2012 | 31/1/2012 | Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease | Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease | Crohn´s Disease | Drug: Metronidazole;Drug: Azathioprine;Drug: Adalimumab | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Effice Servicios Para la Investigacion S.L. | Completed | 18 Years | N/A | Both | 86 | Phase 3 | Spain |
| 38 | NCT01957423 (ClinicalTrials.gov) | March 2012 | 24/9/2013 | Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients. | Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy. | Crohn's Disease | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | N/A | N/A | Both | 41 | N/A | Brazil |
| 39 | EUCTR2010-020137-10-HU (EUCTR) | 12/01/2012 | 22/11/2011 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden | ||
| 40 | JPRN-UMIN000005689 | 2011/09/01 | 31/05/2011 | GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial | Crohn's disease | Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine. Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine. | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 12years-old | 75years-old | Male and Female | 60 | Not applicable | Japan | |
| 41 | EUCTR2010-020137-10-BE (EUCTR) | 23/03/2011 | 04/10/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 42 | JPRN-UMIN000005146 | 2011/03/01 | 25/02/2011 | Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) | Crohn's disease | Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later | Department of Internal Medicine, School of Medicine, Keio University | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan | |
| 43 | NCT01235689 (ClinicalTrials.gov) | February 11, 2011 | 4/11/2010 | Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab;Drug: Prednisone;Drug: Azathioprine | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 252 | Phase 3 | Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 44 | EUCTR2010-020137-10-NL (EUCTR) | 17/12/2010 | 23/12/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden | ||
| 45 | EUCTR2010-020137-10-CZ (EUCTR) | 08/11/2010 | 04/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 46 | EUCTR2010-020137-10-IT (EUCTR) | 07/11/2010 | 08/11/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM | Crohn`s disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401 | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab Trade Name: Azathioprin-ratiopharm 25 mg INN or Proposed INN: Azathioprine Trade Name: Azathioprine - ratiopharm 50 mg INN or Proposed INN: Azathioprine Trade Name: Decortin 5 mg INN or Proposed INN: Prednisone Trade Name: Decortin 20 mg INN or Proposed INN: Prednisone | Abbott GmBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 47 | EUCTR2010-020137-10-ES (EUCTR) | 20/10/2010 | 20/08/2010 | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Enfermedad de Crohn.Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 48 | EUCTR2010-020137-10-FR (EUCTR) | 14/10/2010 | 23/08/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 49 | EUCTR2010-020137-10-DE (EUCTR) | 05/10/2010 | 20/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 50 | EUCTR2010-020137-10-GB (EUCTR) | 20/09/2010 | 19/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 51 | EUCTR2010-020137-10-AT (EUCTR) | 16/09/2010 | 11/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 52 | EUCTR2010-020137-10-SE (EUCTR) | 15/09/2010 | 27/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 53 | NCT01015391 (ClinicalTrials.gov) | November 2009 | 17/11/2009 | Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease | A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection | Crohn's Disease | Drug: T2;Drug: Azathioprine | Jinling Hospital, China | NULL | Recruiting | 18 Years | N/A | Both | 100 | N/A | China |
| 54 | NCT01559142 (ClinicalTrials.gov) | November 2008 | 19/3/2012 | Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease | Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study | Crohn Disease | Drug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone) | Children's Memorial Health Institute, Poland | NULL | Active, not recruiting | 7 Years | 17 Years | Both | 100 | Phase 3 | Poland |
| 55 | EUCTR2008-001131-35-NL (EUCTR) | 14/05/2008 | 29/05/2008 | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months | Trade Name: Remicade Product Name: Infliximab Product Code: EU/1/99/116/003 Trade Name: Imuran Product Name: Azathioprine Product Code: RVG 05565 | Academic Medical Center, department of Gastroenterology and hepatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 56 | 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 |
| 57 | 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 | 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 | |
| 58 | EUCTR2004-002815-10-DE (EUCTR) | 12/12/2005 | 25/04/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 59 | NCT02247258 (ClinicalTrials.gov) | October 2005 | 19/9/2014 | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence. | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study. | Crohn Disease;Recurrence;Azathioprine;Prevention | Drug: Azathioprine;Drug: Azathioprine in case of endoscopic recurrence;Procedure: Ileocolonoscopy;Procedure: Small bowel follow trough | Universitaire Ziekenhuizen Leuven | International organization for the study of inflammatory bowel disease (IOIBD) | Terminated | 16 Years | 75 Years | Both | 63 | Phase 2 | Belgium;Czech Republic;Greece |
| 60 | EUCTR2004-002815-10-GB (EUCTR) | 25/07/2005 | 26/05/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Spain;Denmark;Austria;Germany;United Kingdom;Sweden | ||
| 61 | EUCTR2004-002815-10-ES (EUCTR) | 18/07/2005 | 16/05/2006 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 7.1;Classification code 10011401 | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab Trade Name: Imuran Product Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Spain;Denmark;Austria;Germany;United Kingdom;Sweden | ||
| 62 | EUCTR2004-002815-10-DK (EUCTR) | 07/07/2005 | 10/07/2008 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 63 | NCT00113503 (ClinicalTrials.gov) | July 2005 | 8/6/2005 | Imuran Dosing in Crohn's Disease Study | A Multi-site Trial of Azathioprine Dosing in Crohn's Disease | Crohn's Disease | Drug: Azathioprine weight-based dose;Drug: Azathioprine individualised dose | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Prometheus Laboratories | Terminated | 10 Years | 70 Years | All | 50 | Phase 2 | United States;Canada |
| 64 | NCT00546546 (ClinicalTrials.gov) | July 2005 | 18/10/2007 | Early Immunosuppressants in Crohn's Disease | Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease | Crohn's Disease | Drug: early immunosuppressants (azathioprine, methotrexate) | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Société Nationale Française de Gastroentérologie;Société Nationale Française de Gastroentérologie | Completed | 18 Years | N/A | Both | 120 | Phase 4 | France |
| 65 | EUCTR2005-001148-22-SK (EUCTR) | 27/06/2005 | 12/05/2005 | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | Crohn's disease MedDRA version: 7.1;Level: Low;Classification code 10011401 | Trade Name: Certican Product Name: Certican Product Code: RAD001 INN or Proposed INN: Everolimus Trade Name: Imuran Product Name: Imuran INN or Proposed INN: Azathioprine | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Slovakia | ||
| 66 | EUCTR2004-002815-10-SE (EUCTR) | 24/05/2005 | 11/04/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 67 | EUCTR2004-002815-10-AT (EUCTR) | 04/05/2005 | 30/03/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 7.1;Classification code 10011401 | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab Trade Name: Imuran Product Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Spain;Denmark;Austria;Germany;United Kingdom;Sweden | |||
| 68 | NCT00098111 (ClinicalTrials.gov) | April 2005 | 3/12/2004 | Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease | A Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS) | Crohn's Disease | Drug: azathioprine | Massachusetts General Hospital | NULL | Terminated | 14 Years | N/A | Both | 31 | Phase 3 | United States |
| 69 | NCT00094458 (ClinicalTrials.gov) | March 2005 | 19/10/2004 | Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC | Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy | Crohn Disease | Biological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusion | Centocor Ortho Biotech Services, L.L.C. | Schering-Plough | Completed | 21 Years | 99 Years | All | 508 | Phase 3 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom |
| 70 | NCT00796250 (ClinicalTrials.gov) | November 1, 2003 | 21/11/2008 | Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732) | Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine | Crohn's Disease | Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 3 | NULL |
| 71 | NCT00976690 (ClinicalTrials.gov) | October 2002 | 11/9/2009 | Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease | A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease | Crohn Disease | Drug: Azathioprine OR Mesalazine | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Completed | 18 Years | N/A | Both | 83 | Phase 3 | France |
| 72 | NCT00946946 (ClinicalTrials.gov) | February 2002 | 24/7/2009 | Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine | Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence | Crohn's Disease | Drug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 78 | Phase 3 | Austria;Germany |
| 73 | EUCTR2016-000522-18-PL (EUCTR) | 04/04/2018 | Risk-stratified randomized 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 randomized 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 | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: HUMIRA INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | PIBDnet (Pediatric Inflammatory Bowel Disease Network) | NULL | NA | Female: no Male: no | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 74 | EUCTR2016-000522-18-FR (EUCTR) | 21/06/2016 | Risk stratified randomized 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 randomized 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 | Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: humira INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Methotrexate Product Name: methotrexate | PIBDNet | NULL | NA | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom |