Comparing Azathioprine and Methotrexate Combined with Adalimumab for Treating Crohns Disease A Phase 3 Open-label Randomized Trial

What this Trial Is About

Researchers are comparing two immunosuppressant drugs, azathioprine AZA and methotrexate MTX, when combined with adalimumab to treat Crohns disease CD. This trial aims to determine which combination improves short-term endoscopic, clinical, and pharmacological outcomes more effectively. The study is an open-label randomized controlled trial focusing on adults with active Crohns disease who have not responded well to conventional treatments. The study involves two treatment groups one receiving subcutaneous adalimumab combined with oral AZA capsules daily at 2.5 mg per kilogram, and the other receiving adalimumab combined with weekly subcutaneous MTX injections at 25 mg. Adalimumab is given at 160 mg initially, then 80 mg at week 2, 40 mg at week 6, and 40 mg every two weeks thereafter. The trial evaluates the response to these combination therapies over a 26-week period. Participants will undergo assessments including endoscopic evaluations to measure inflammation, clinical activity scoring, and blood tests measuring serum albumin, C-reactive protein, thrombocytosis, and hemoglobin. The main outcome measured is the change in endoscopic response between the AZA and MTX groups after 26 weeks. Safety and treatment adherence will be monitored throughout the study duration, which started in August 2021 and is expected to end by May 2027.

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