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Crohn DiseasePhase 3COMETNCT05040464

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

A Phase 3 study testing AZA capsules, MTX and blood sample in people with Crohn Disease and Azathioprine, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Azathioprine, Methotrexate
What is being tested?
AZA capsules, MTX and blood sample
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteFrance
Study dates
26 Aug 2021to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Planning pregnancy, pregnancy or lactation or absence of contraception
  • Known substance abusers
  • Use of any investigational drug within 30 days
  • Adults protected by law

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mathurin Fumery, Pr contact

03 22 08 88 51

Fumery.mathurin@chu-amiens.fr

France1 site, 1 recruiting

  • CHU Amiens

    Amiens, 80480

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

    Benjamin Pariente, Pr

    Recruiting

Other trials in France

About this study

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.

Being tested
AZA capsules, MTX, blood sample
Keywords
Crohn Disease, Combinations of therapy, anti-Tumor Necrosis Factor, azathioprine, methotrexate
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZA capsulesDrug

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

  • MTXDrug

    MTX 25 mg SC once a week

  • blood sampleBiological

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

Study groups in NCT05040464
Study groupRoleWhat they receive
AZA groupExperimentalCombination 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
Receives: Drug: AZA capsules; Biological: blood sample
MTX groupExperimentalCombination 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
Receives: Drug: MTX; Biological: blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start26 Aug 2021
  3. Primary completionAug 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040464
Sponsor's protocol ID
PI2021_843_0080
Acronym
COMET
Status last verified
May 2025
First submitted
26 Aug 2021
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZA capsules, MTX and blood sample in people with Crohn Disease and Azathioprine, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mathurin Fumery, Pr (03 22 08 88 51, Fumery.mathurin@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of the endoscopic response between AZA and MTX groups (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05040464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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