Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Phase 3 · Testing AZA capsules, MTX and blood sample · 1 site · Centre Hospitalier Universitaire, Amiens
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing AZA capsules (a drug), MTX (a drug) and blood sample (a biologic) as a possible treatment. Condition(s) listed: Crohn Disease, Azathioprine and Methotrexate.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Male or female patients with age > 18 years
- Crohn's disease for at least 6 weeks,
- Clinically active with CDAI > 150
Plus 5 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 166 participants are expected to take part.
- Start date: 2021-08-26.
- Main results expected around 2026-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Variation of the endoscopic response between AZA and MTX groups (26 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn Disease; Azathioprine; Methotrexate |
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
| Collaborators | Nantes University Hospital; AP-HP - HU BEAUJON; CHU de Reims; Centre Hospitalier Universitaire de Besancon; CHRU LILLE; University Hospital, Bordeaux; Henri Mondor University Hospital; Hospices Civils de Lyon; Rennes University Hospital; CHU ROUEN - HOPITAL DE BOIS-GUILLAUME; CHRU TOURS; University Hospital, Toulouse; University Hospital, Montpellier; Centre Hospitalier Universitaire de Nice; Central Hospital, Nancy, France; University Hospital, Caen; Centre Hospitalier Universitaire de Saint Etienne; CH TOURCOING; Hopitaux Civils de Colmar; CH COTE BASQUE; CH ROUBAIX; CHI CRETEIL; CHI TOULON LA SEYNE; CH VALENCE; CMC Ambroise Paré, Pierre Cherest, Hartmann; University Hospital, Clermont-Ferrand |
| Enrollment | 166 (estimated) |
| Start date | 2021-08-26 |
| Primary completion (est.) | 2026-08 |
| First posted | 2021-09-10 |
| Last updated | 2025-05-28 |
| 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 |
Interventions
- AZA capsules (Drug)
oral AZA capsules at a daily dose of 2.5 mg per kilogram, - MTX (Drug)
MTX 25 mg SC once a week - blood sample (Biological)
The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens | Amiens | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.