NCT05040464

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Azathioprine
• Methotrexate

Interventions

Type	Name	Description
DRUG	AZA capsules	oral AZA capsules at a daily dose of 2.5 mg per kilogram,
DRUG	MTX	MTX 25 mg SC once a week
BIOLOGICAL	blood sample	The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.

Timeline

• Start date: 2021-08-26
• Primary completion: 2026-08-01
• Completion: 2027-05-01
• First posted: 2021-09-10
• Last updated: 2025-05-28

Locations

1 site across 1 country: France