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Study tests if one drug can replace two for inflammatory bowel disease

NCT ID NCT07564609

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using just one medication (infliximab) under the skin works as well as using it together with another immune-suppressing drug for people with Crohn's disease or ulcerative colitis. About 420 adults who have already started infliximab will be followed for at least 3 months. The goal is to see if the simpler approach can keep symptoms away without needing steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Crohn's disease or ulcerative colitis treated in the day care unit at Clermont-Ferrand University Hospital.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with UC (REMONO-UC) or with CD (REMONO-CD) ≥ 18 years * Who received at least one SC injection of infliximab after IV induction (5 mg/kg at week 0, week 2 ± week 6) * Infliximab started for symptomatic CD (PRO2: abdominal pain \> 1 or stool frequency \>3) or UC (partial Mayo score \>2) * Follow-up of at least 3 months (except for those who failed or were intolerant to SC infliximab before 3 months) Exclusion Criteria: * Unclassified colitis * Infliximab started for isolated perianal CD, to prevent CD endoscopic postoperative recurrence or for acute severe colitis * Permanent stoma * Total colectomy with IPAA * Concomitant other biological therapy or small molecule

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Amiens

    Amiens, France

  • CHU Besançon

    Besançon, France

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000, France

  • CHU Dijon

    Dijon, France

  • CHU Grenoble

    Grenoble, France

  • CHU Lille

    Lille, France

  • CHU Monptellier

    Montpellier, France

  • CHU Nancy

    Nancy, France

  • CHU Nantes

    Nantes, France

  • CHU Nîmes

    Nîmes, France

  • CHU Rouen

    Rouen, France

  • CHU Toulouse

    Toulouse, France

  • Hospice Civil de Lyon

    Lyon, France

  • Hôpital Beaujon AP-HP

    Clichy, France

  • Hôpital Bicêtre AP-HP

    Le Kremlin-Bicêtre, France

  • Hôpital Henri-Mondor AP-HP

    Créteil, France

  • Hôpital Henri-Mondor AP-HP

    Marseille, France

  • Institut des MICI

    Neuilly-sur-Seine, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.