Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Recruiting
Phase 3
Interventional Study
Crohn Disease
Azathioprine
Methotrexate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 166 (estimated)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Other
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About This Trial
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 thera…
Trial Locations
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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 …
Contacts