Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

Crohn Disease Clinical Trial

— COMET  

Official title:

Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040464
• Other study ID #: PI2021_843_0080
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Azathioprine
• Crohn Disease
• Methotrexate

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