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

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.

Conditions

• Crohn Disease
• Azathioprine
• Methotrexate

Interventions

DRUG

AZA capsules

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

DRUG

MTX

MTX 25 mg SC once a week

BIOLOGICAL

blood sample

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

Sponsors & Collaborators

• Nantes University Hospital

  collaborator OTHER

• AP-HP - HU BEAUJON

  collaborator UNKNOWN

• CHU REIMS

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• CHRU LILLE

  collaborator UNKNOWN

• University Hospital, Bordeaux

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• CHU Rennes,France

  collaborator UNKNOWN

• CHU ROUEN - HOPITAL DE BOIS-GUILLAUME

  collaborator UNKNOWN

• CHRU TOURS

  collaborator UNKNOWN

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• CHU NICE

  collaborator UNKNOWN

• CHU NANCY

  collaborator UNKNOWN

• CHU CAEN

  collaborator UNKNOWN

• CHU SAINT-ETIENNE

  collaborator UNKNOWN

• CH TOURCOING

  collaborator UNKNOWN

• Hopitaux Civils de Colmar

  collaborator OTHER

• CH COTE BASQUE

  collaborator UNKNOWN

• CH ROUBAIX

  collaborator UNKNOWN

• CHI CRETEIL

  collaborator UNKNOWN

• CHI TOULON LA SEYNE

  collaborator UNKNOWN

• CH VALENCE

  collaborator UNKNOWN

• CMC Ambroise Paré, Pierre Cherest, Hartmann

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-26

Primary Completion

2026-08-31

Completion

2027-05-31

Countries

• France

Study Locations