RecruitingPhase 3NCT05040464

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

Enrollment

166 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two standard immune-suppressing drugs — azathioprine versus methotrexate — when added to adalimumab (a biologic injection) for the treatment of moderate-to-severe Crohn's disease to find out which combination works better. **You may be eligible if...** - You are over 18 with a diagnosis of Crohn's disease for at least 6 weeks - Your Crohn's disease is currently active (CDAI score above 150) with confirmed active inflammation on colonoscopy - You have not responded to or cannot tolerate conventional Crohn's medications - You are starting adalimumab treatment - You use effective contraception if applicable **You may NOT be eligible if...** - You have short bowel syndrome, ostomy, bowel obstruction, abscess, or recent abdominal surgery (within 3 months) - You have previously had a bad reaction to azathioprine (thiopurines) or methotrexate - You are pregnant or planning to become pregnant - You have serious liver, kidney, or blood problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZA capsules

oral AZA capsules at a daily dose of 2.5 mg per kilogram,

DRUGMTX

MTX 25 mg SC once a week

BIOLOGICALblood sample

The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.


Locations(1)

CHU Amiens

Amiens, France

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NCT05040464


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