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

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.

NCT Number	NCT05040464
Lead Sponsor	Centre Hospitalier Universitaire, Amiens Collaborators: Nantes University Hospital, AP-HP - HU BEAUJON, CHU de Reims, Centre Hospitalier Universitaire de Besancon, CHRU LILLE, University Hospital, Bordeaux, Henri Mondor University Hospital, Hospices Civils de Lyon, Rennes University Hospital, CHU ROUEN - HOPITAL DE BOIS-GUILLAUME, CHRU TOURS, University Hospital, Toulouse, University Hospital, Montpellier, Centre Hospitalier Universitaire de Nice, Central Hospital, Nancy, France, University Hospital, Caen, Centre Hospitalier Universitaire de Saint Etienne, CH TOURCOING, Hopitaux Civils de Colmar, CH COTE BASQUE, CH ROUBAIX, CHI CRETEIL, CHI TOULON LA SEYNE, CH VALENCE, CMC Ambroise Paré, Pierre Cherest, Hartmann, University Hospital, Clermont-Ferrand
Conditions	Crohn Disease, Azathioprine, Methotrexate
Enrollment	166 participants
Start Date	2021-08-26
Primary Completion	2026-08 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2025-05-28