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Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Sponsor: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2021-08-26
Completion Date
2027-05
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
AZA capsules
oral AZA capsules at a daily dose of 2.5 mg per kilogram,
MTX
MTX 25 mg SC once a week
blood sample
The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.
Locations (1)
CHU Amiens
Amiens, France