NCT05040464 Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
| NCT ID | NCT05040464 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2021-08-26 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 166 participants in total. It began in 2021-08-26 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05040464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05040464 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 166 participants.
Is NCT05040464 currently recruiting?
Yes, NCT05040464 is actively recruiting participants. Contact the research team at Fumery.mathurin@chu-amiens.fr for enrollment information.
Where is the NCT05040464 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05040464 clinical trial?
NCT05040464 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 166 participants.