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
39 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
Researchers are comparing two immunosuppressant drugs, azathioprine (AZA) and methotrexate (MTX), when combined with adalimumab to treat Crohn's disease (CD). This trial aims to determine which combination improves short-term endoscopic, clinical, and pharmacological outcomes more effectively. The study is an open-label randomized controlled trial focusing on adults with active Crohn's disease who have not responded well to conventional treatments. The study involves two treatment groups: one receiving subcutaneous adalimumab combined with oral AZA capsules daily at 2.5 mg per kilogram, and the other receiving adalimumab combined with weekly subcutaneous MTX injections at 25 mg. Adalimumab is given at 160 mg initially, then 80 mg at week 2, 40 mg at week 6, and 40 mg every two weeks thereafter. The trial evaluates the response to these combination therapies over a 26-week period. Participants will undergo assessments including endoscopic evaluations to measure inflammation, clinical activity scoring, and blood tests measuring serum albumin, C-reactive protein, thrombocytosis, and hemoglobin. The main outcome measured is the change in endoscopic response between the AZA and MTX groups after 26 weeks. Safety and treatment adherence will be monitored throughout the study duration, which started in August 2021 and is expected to end by May 2027.
CONDITIONS
Brief 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 Crohn's Disease Activity Index (CDAI) greater than 150
- Active inflammation confirmed by endoscopy with Crohn's Disease Endoscopic Index of Severity (CDEIS) over 4 at baseline
- Not responding to or intolerant of conventional therapy and starting adalimumab treatment
- Followed at a center within the GETAID network
- Fertile men and women of childbearing potential must use adequate contraception
- Provided written informed consent
You will not qualify if you...
- Short bowel syndrome, ostomy, symptomatic stricture, abscess, or abdominal surgery within the past 3 months
- Non-passable colonic stricture
- Previous intolerance to thiopurines or methotrexate
- Prior exposure to adalimumab
- Contraindications to immunosuppressants or anti-TNF therapies
- Other serious illnesses interfering with participation
- Pregnancy, lactation, planning pregnancy, or lack of contraception
- Known substance abuse
- Use of investigational drugs within 30 days prior to enrollment
- Adults protected by law
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive combination therapy with adalimumab and either oral AZA capsules or sub-cutaneous MTX injections.
Weekly visits for the first 6 weeks, then biweekly visits up to Week 26
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
M
Mathurin Fumery, Pr
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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