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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05040464
Other study ID # PI2021_843_0080
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 26, 2021
Est. completion date March 2024

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Mathurin Fumery, Pr
Phone 03 22 08 88 51
Email Fumery.mathurin@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 166
Est. completion date March 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AZA capsules
oral AZA capsules at a daily dose of 2.5 mg per kilogram,
MTX
MTX 25 mg SC once a week
Biological:
blood sample
The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of the endoscopic response between AZA and MTX groups Variation of the endoscopic response to AZA in combination with adalimumab and to MTX in combination with adalimumab in patients with CD.
The endoscopic reference score (EREFS) is used to determine severity of 5 endoscopic findings: edema, rings, exudates, furrows, and structures. The EREFS classification system rates the severity of edema (0-2), rings (0-3), exudates (0-2), furrows (0-2), and strictures (0-1)
26 weeks
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