Comparing Azathioprine and Methotrexate with Adalimumab for Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of azathioprine (AZA) versus methotrexate (MTX) when used in combination with adalimumab for treating patients with Crohn's disease. The study will enroll patients who have clinically active Crohn's disease and have not responded to conventional therapies. Participants will receive either AZA or MTX alongside adalimumab, and their outcomes will be assessed through endoscopic and clinical evaluations. The hypothesis is that AZA may provide better results than MTX in this combination therapy setting.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens
  Amiens, France Recruiting

Study contacts

• Study coordinator: Mathurin Fumery, Pr
• Email: Fumery.mathurin@chu-amiens.fr
• Phone: 03 22 08 88 51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.