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NCT Number: NCT05040464

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

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.

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Key information

Conditions

Crohn Disease Azathioprine Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Methotrexate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Antony Buisson, MD

PRINCIPAL_INVESTIGATOR

Arnaud Boureille, Pr

PRINCIPAL_INVESTIGATOR

Benjamin Pariente, Pr

PRINCIPAL_INVESTIGATOR

Clea Rouillon, MD

PRINCIPAL_INVESTIGATOR

David Laharie, Pr

PRINCIPAL_INVESTIGATOR

Duveau Nicolas, MD

PRINCIPAL_INVESTIGATOR

Guillaume Savoye, Pr

PRINCIPAL_INVESTIGATOR

Laurent Peyrin-Biroulet, Pr

PRINCIPAL_INVESTIGATOR

Lucine Vuitton, MD

PRINCIPAL_INVESTIGATOR

Mathurin Fumery, Pr

CONTACT

[email protected]

03 22 08 88 51

Painchart, MD

PRINCIPAL_INVESTIGATOR

Romain Altwegg, MD

PRINCIPAL_INVESTIGATOR

Tavernier Noemie, MD

PRINCIPAL_INVESTIGATOR

Vanessa Bonjemah, MD

PRINCIPAL_INVESTIGATOR

Xavier Roblin, Pr

PRINCIPAL_INVESTIGATOR

Yoram Bouhnik, Pr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients with age > 18 years
  • Crohn's disease for at least 6 weeks,
  • Clinically active with CDAI > 150
  • Active inflammation by endoscopy (CDEIS > 4) at baseline
  • Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab
  • Patient followed in a center belonging to the GETAID network
  • Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.
  • Written consent

Exclusion criteria

  • Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months)
  • Non-passable colonic stricture
  • Previous intolerance to thiopurines or MTX
  • Previous exposition to adalimumab
  • Contra-indication to immunosuppressants or anti-TNF
  • Others serious simultaneous illness that could interfere with study participation
  • Planning pregnancy, pregnancy or lactation or absence of contraception
  • Known substance abusers
  • Use of any investigational drug within 30 days
  • Adults protected by law

Treatment and study plan

AZA capsules

Drug

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

MTX

Drug

MTX 25 mg SC once a week

Blood sample

Biological

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

Primary outcomes

  1. Variation of the endoscopic response between AZA and MTX groups

    Time frame: 26 weeks

    Variation of the endoscopic response to AZA in combination with adalimumab and to MTX in combination with adalimumab in patients with CD.

    The endoscopic reference score (EREFS) is used to determine severity of 5 endoscopic findings: edema, rings, exudates, furrows, and structures. The EREFS classification system rates the severity of edema (0-2), rings (0-3), exudates (0-2), furrows (0-2), and strictures (0-1)

Study contacts

Contact information is provided by the study sponsor or research team.

Mathurin Fumery, Pr

CONTACT

[email protected]

03 22 08 88 51

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • AP-HP - HU BEAUJON
  • CH COTE BASQUE
  • CH ROUBAIX
  • CH TOURCOING
  • CH VALENCE
  • CHI CRETEIL
  • CHI TOULON LA SEYNE
  • CHRU LILLE
  • CHRU TOURS
  • CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
  • CHU de Reims
  • CMC Ambroise Paré, Pierre Cherest, Hartmann
  • Central Hospital, Nancy, France
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire de Nice
  • Centre Hospitalier Universitaire de Saint Etienne
  • Henri Mondor University Hospital
  • Hopitaux Civils de Colmar
  • Hospices Civils de Lyon
  • Nantes University Hospital
  • Rennes University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Caen
  • University Hospital, Clermont-Ferrand
  • University Hospital, Montpellier
  • University Hospital, Toulouse

Registry information

Acronym: COMET

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 10, 2021
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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