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Taking people in FrancePhase 3

Comparing two add-on medicines with adalimumab for Crohn's disease

Compares azathioprine and methotrexate, each taken with adalimumab, in adults with Crohn's disease.

Key facts

Who runs it
Centre Hospitalier Universitaire, Amiens
Where
Amiens, FranceSee the site
Trial code
Registry title
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Status
Recruiting
Phase
Phase 3
People taking part
166 people, planned
Started
26 Aug 2021
Expected to end
May 2027
Type of study
Interventional, 2 groups
Treatments tested
  • AZA capsules
  • MTX
  • blood sample
Record updated
28 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active Crohn's disease who did not respond to usual treatments and are starting adalimumab. It compares azathioprine with methotrexate given together with adalimumab.

Age
Older than 18 years.
Sex
Men and women can join.
Disease stage
Crohn's disease for at least 6 weeks, clinically active (CDAI > 150), with active inflammation seen by endoscopy (CDEIS > 4).
Earlier treatment
Did not respond to usual therapy, or cannot take it or tolerate it, and is starting adalimumab. No earlier adalimumab.

Main reasons for not taking part

  • Short bowel syndrome, ostomy, symptomatic stricture, abscess, or abdominal surgery in the last 3 months
  • Earlier intolerance to thiopurines or methotrexate
  • Earlier treatment with adalimumab
  • Pregnancy, planning pregnancy, breastfeeding, or no contraception
  • Any investigational drug within 30 days

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in France

  • CHU AmiensAmiens, FranceContact: Mathurin Fumery, PrTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • AZA groupTreatment being tested

    Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg/kg

    Treatment: AZA capsules and blood sample

  • MTX groupTreatment being tested

    Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week

    Treatment: MTX and blood sample

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Plain-language title
Comparing two add-on medicines with adalimumab for Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 May 2025