NCT05040464RecruitingPhase 3
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 26 Aug 2021
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Crohn's disease
- NCT number
- NCT05040464
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 166
- From 26 Aug 2021 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intolerance to thiopurines or MTX
- Previous exposition to adalimumab
- Use of any investigational drug within 30 days
Other illness
- Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (\<3 months)
- Others serious simultaneous illness that could interfere with study participation
Other
- Non-passable colonic stricture
- Contra-indication to immunosuppressants or anti-TNF
- Planning pregnancy, pregnancy or lactation or absence of contraception
- Known substance abusers
- Adults protected by law
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.