Clinical trial NCT05040464: Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Official title: Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn Disease
Azathioprine
Methotrexate
Keywords: Crohn Disease
Combinations of therapy
anti-Tumor Necrosis Factor
azathioprine
methotrexate
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
name: AP-HP - HU BEAUJON
name: CHU REIMS
name: Centre Hospitalier Universitaire de Besancon
name: CHRU LILLE
name: University Hospital, Bordeaux
name: Henri Mondor University Hospital
name: Hospices Civils de Lyon
name: CHU Rennes,France
name: CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
name: CHRU TOURS
name: CHU Toulouse
name: University Hospital, Montpellier
name: CHU NICE
name: CHU NANCY
name: CHU CAEN
name: CHU SAINT-ETIENNE
name: CH TOURCOING
name: Hopitaux Civils de Colmar
name: CH COTE BASQUE
name: CH ROUBAIX
name: CHI CRETEIL
name: CHI TOULON LA SEYNE
name: CH VALENCE
name: CMC Ambroise Paré, Pierre Cherest, Hartmann
name: University Hospital, Clermont-Ferrand
First posted: 2021-09-10
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Variation of the endoscopic response between AZA and MTX groups
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: