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Recruiting NCT05040464

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

Phase III Interventional Crohn Disease Azathioprine Methotrexate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZA capsules, MTX, blood sample.
Who it may be relevant to
Registry conditions: Crohn Disease, Azathioprine, Methotrexate. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Variation of the endoscopic response between AZA and MTX groups [Time frame: 26 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT05040464 · PI2021_843_0080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗