Clinical Trials Logo
  1. Home
  2. Methotrexate
  3. NCT05040464

Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial — COMET  

Crohn Disease Clinical Trial

Official title:
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

Clinical Trial Summary

Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety. The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05040464
Study type Interventional
Source Centre Hospitalier Universitaire, Amiens
Contact Mathurin Fumery, Pr
Phone 03 22 08 88 51
Email Fumery.mathurin@chu-amiens.fr
Status Recruiting
Phase Phase 3
Start date August 26, 2021
Completion date March 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Recruiting NCT05169593 - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy Phase 4
Recruiting NCT06116604 - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting NCT05627128 - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease N/A
Recruiting NCT05294107 - Intestinal Organoids N/A
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Withdrawn NCT04349449 - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT03058679 - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease N/A
Completed NCT02871635 - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity Phase 3
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Recruiting NCT03913572 - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Terminated NCT04102111 - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease Phase 2
Recruiting NCT04997733 - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal Phase 3
Recruiting NCT05906576 - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients Phase 4
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04502303 - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease Phase 2