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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-26

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease Azathioprine Methotrexate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZA group

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

Group Type EXPERIMENTAL

AZA capsules

Intervention Type DRUG

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

blood sample

Intervention Type BIOLOGICAL

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

MTX group

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

Group Type EXPERIMENTAL

MTX

Intervention Type DRUG

MTX 25 mg SC once a week

blood sample

Intervention Type BIOLOGICAL

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

Interventions

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AZA capsules

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

Intervention Type DRUG

MTX

MTX 25 mg SC once a week

Intervention Type DRUG

blood sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No