Comparing Azathioprine and Methotrexate with Adalimumab for Crohn's Disease
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
PHASE3 · Centre Hospitalier Universitaire, Amiens · NCT05040464
This study is testing whether adding azathioprine or methotrexate to adalimumab helps people with Crohn's disease who haven't improved with other treatments.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Drugs / interventions | adalimumab, methotrexate |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05040464 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with active Crohn's disease who have not responded to conventional therapies.
Not a fit: Patients with short bowel syndrome, ostomy, or those who have previously been intolerant to thiopurines or methotrexate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with Crohn's disease.
How similar studies have performed: Previous studies have suggested the effectiveness of combination therapies in Crohn's disease, but this specific comparison of AZA and MTX is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (RECRUITING)
Study contacts
- Study coordinator: Mathurin Fumery, Pr
- Email: Fumery.mathurin@chu-amiens.fr
- Phone: 03 22 08 88 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Azathioprine, Methotrexate, Combinations of therapy, anti-Tumor Necrosis Factor, azathioprine, methotrexate