Actively Recruiting
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-28
166
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
N
Nantes University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged over 18 years
- Diagnosed with Crohn's disease for at least 6 weeks
- Clinically active disease with a Crohn's Disease Activity Index (CDAI) greater than 150
- Evidence of active inflammation by endoscopy at baseline (CDEIS greater than 4)
- Not responding to conventional therapy or intolerant/have contraindications and starting adalimumab treatment
- Patient followed at a center within the GETAID network
- Fertile men and women must use adequate contraception as per study requirements
- Provided written informed consent
You will not qualify if you...
- Short bowel syndrome, ostomy, symptomatic stricture, abscess, or recent abdominal surgery within 3 months
- Non-passable colonic stricture
- Previous intolerance to thiopurines or methotrexate
- Prior treatment with adalimumab
- Contraindications to immunosuppressants or anti-TNF agents
- Other serious illnesses that could affect participation
- Planning pregnancy, currently pregnant or breastfeeding, or lack of contraception
- Known substance abuse
- Use of any investigational drug within the last 30 days
- Adults protected by law
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
M
Mathurin Fumery, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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