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RECRUITINGPHASE3

Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

NCT05040464•Centre Hospitalier Universitaire, Amiens

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

CHU Amiens

Amiens, France

Key Dates

Start Date

August 26, 2021

Primary Completion Date

August 1, 2026

Completion Date

May 1, 2027

Last Updated

May 28, 2025

Enrollment

166

ESTIMATED participants

Conditions

Crohn DiseaseAzathioprineMethotrexate

Interventions

AZA capsules

DRUG

MTX

DRUG

blood sample

BIOLOGICAL

Contacts

Mathurin Fumery, Pr

CONTACT

03 22 08 88 51 Fumery.mathurin@chu-amiens.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

Inclusion Criteria

Exclusion Criteria

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