Clinical trial for Crohn Disease
Official title Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05040464
What this study is testing
What is AZA capsules?
AZA capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.