Plain-English translation of NCT05040464 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether a combination of adalimumab (a biologic injection) paired with azathioprine works better than adalimumab paired with methotrexate for treating Crohn's disease. Both combinations are already used in clinical practice, but doctors want to know which pairing is most effective and safest. You would receive one of these two treatment combinations and be monitored over time to see how well it controls your disease.
Doctors know that combining a biologic medication with an immune-suppressing drug works better than using either one alone for Crohn's disease. However, it's not yet clear which immune-suppressing drug works best when paired with this particular biologic, so this trial aims to answer that question.
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You would be randomly assigned to receive one of two treatment combinations: either the biologic injection plus azathioprine pills taken by mouth daily, or the biologic injection plus methotrexate given as a weekly injection. You would start with higher doses of the biologic to get it into your system, then move to a maintenance dose every other week. Throughout the study, you would have clinic visits where doctors check on how you're doing, possibly perform endoscopy procedures to see if the inflammation is improving, and monitor your blood work to ensure the medications are working safely.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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