NCT05040464

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
12mo left

Started Aug 2021

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Aug 2021May 2027

First Submitted

Initial submission to the registry

August 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

August 26, 2021

Last Update Submit

May 22, 2025

Conditions

Crohn DiseaseAzathioprineMethotrexate

Keywords

Crohn DiseaseCombinations of therapyanti-Tumor Necrosis Factorazathioprinemethotrexate

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AZA group

EXPERIMENTAL

Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg/kg

Drug: AZA capsulesBiological: blood sample

MTX group

EXPERIMENTAL

Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week

Drug: MTXBiological: blood sample

Interventions

AZA capsulesDRUG

oral AZA capsules at a daily dose of 2.5 mg per kilogram,

AZA group
MTXDRUG

MTX 25 mg SC once a week

MTX group
blood sampleBIOLOGICAL

The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.

AZA groupMTX group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
  • Planning pregnancy, pregnancy or lactation or absence of contraception
  • Known substance abusers
  • Use of any investigational drug within 30 days
  • Adults protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Mathurin Fumery, Pr

CONTACT

03 22 08 88 51Fumery.mathurin@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 10, 2021

Study Start

August 26, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)