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

Study acronym: COMET
StatusRecruiting
PhasePhase 3
Started
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Record status
This record was last updated May 28, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 2023 to Aug 2026
    • Study completion date: Mar 2024 to May 2027
    • Collaborators expanded, about 91 words
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05040464
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators: Nantes University Hospital, AP-HP - HU BEAUJON, CHU de Reims, Centre Hospitalier Universitaire de Besancon, CHRU LILLE, University Hospital, Bordeaux, Henri Mondor University Hospital, Hospices Civils de Lyon, Rennes University Hospital, CHU ROUEN - HOPITAL DE BOIS-GUILLAUME, CHRU TOURS, University Hospital, Toulouse, University Hospital, Montpellier, Centre Hospitalier Universitaire de Nice, Central Hospital, Nancy, France, University Hospital, Caen, Centre Hospitalier Universitaire de Saint Etienne, CH TOURCOING, Hopitaux Civils de Colmar, CH COTE BASQUE, CH ROUBAIX, CHI CRETEIL, CHI TOULON LA SEYNE, CH VALENCE, CMC Ambroise Paré, Pierre Cherest, Hartmann, University Hospital, Clermont-Ferrand
Conditions
(from sponsor)		 Crohn Disease, Azathioprine, Methotrexate
Related terms Crohn Disease
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov