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.
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
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
Parallel
AZA capsules
Drugoral AZA capsules at a daily dose of 2.5 mg per kilogram,
MTX
DrugMTX 25 mg SC once a week
blood sample
Biological/VaccineThe lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.
Variation of the endoscopic response between AZA and MTX groups
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)
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Centre Hospitalier Universitaire, Amiens
Lead sponsor
Nantes University Hospital
Collaborator
AP-HP - HU BEAUJON
Collaborator
CHU de Reims
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
CHRU LILLE
Collaborator
University Hospital, Bordeaux
Collaborator
Henri Mondor University Hospital
Collaborator
Hospices Civils de Lyon
Collaborator
Rennes University Hospital
Collaborator
CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
Collaborator
CHRU TOURS
Collaborator
University Hospital, Toulouse
Collaborator
University Hospital, Montpellier
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator
Central Hospital, Nancy, France
Collaborator
University Hospital, Caen
Collaborator
Centre Hospitalier Universitaire de Saint Etienne
Collaborator
CH TOURCOING
Collaborator
Hopitaux Civils de Colmar
Collaborator
CH COTE BASQUE
Collaborator
CH ROUBAIX
Collaborator
CHI CRETEIL
Collaborator
CHI TOULON LA SEYNE
Collaborator
CH VALENCE
Collaborator
CMC Ambroise Paré, Pierre Cherest, Hartmann
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
