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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Sep 7, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of two different medications, azathioprine (AZA) and methotrexate (MTX), when used alongside adalimumab, a common treatment for Crohn's disease. Researchers want to find out which combination works better for improving symptoms and healing in patients with active Crohn's disease. The trial is open to adults over 18 years old who have been diagnosed with Crohn's disease for at least six weeks and are currently experiencing significant symptoms. Participants should not have responded to traditional treatments and must be starting treatment with adalimumab.

If you join this trial, you will receive either AZA or MTX along with adalimumab, and the study will monitor your health closely to see how well the treatment is working. To be eligible, you should not have certain serious conditions, such as recent surgeries or specific gastrointestinal issues, and you need to provide informed consent to participate. This study is currently recruiting participants, so if you or a loved one are interested and meet the criteria, it could be an opportunity to contribute to important research in Crohn's disease treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients with age \> 18 years
• • Crohn's disease for at least 6 weeks,
• • Clinically active with CDAI \> 150
• • Active inflammation by endoscopy (CDEIS \> 4) at baseline
• • Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab
• • Patient followed in a center belonging to the GETAID network
• • Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.
• • Written consent
• Exclusion Criteria:
• • Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (\<3 months)
• • Non-passable colonic stricture
• • Previous intolerance to thiopurines or MTX
• • Previous exposition to adalimumab
• • Contra-indication to immunosuppressants or anti-TNF
• • Others serious simultaneous illness that could interfere with study participation
• • Planning pregnancy, pregnancy or lactation or absence of contraception
• • Known substance abusers
• • Use of any investigational drug within 30 days
• • Adults protected by law