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Can IBD patients safely stretch their infusion schedule? new study tests two strategies

NCT ID NCT03841942

Disease control Sponsor: University Hospital, Montpellier 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 people with inflammatory bowel disease (Crohn's disease or ulcerative colitis) who are in deep remission. It compares two methods for gradually increasing the time between infliximab infusions: one based on symptoms and one based on drug levels in the blood. The goal is to see which approach better maintains remission and reduces the number of infusions needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
infliximab
What this could lead to
If successful, this could allow some IBD patients to receive fewer infusions while maintaining remission, reducing treatment burden.
What could go wrong
This is a small, early-stage study. Spacing infusions may increase the risk of disease flare-ups or loss of remission.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

64 people

The number who actually took part.

Started

Jun 2019

Finished

Oct 2023

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.

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: * Age greater than 18 years * Patients with a diagnosis of Crohn's disease or ulcerative colitis according to clinical, biological, morphological and endoscopic criteria defined by the ECCO guidelines22, 23 * Patients in deep remission since at least 6 months17: * CDAI \< 150 for CD, Partial Mayo score \< 3 for UC * CRP (C reactive protein) \< 10 mg/l * CDEIS \< 6 (\<3 in each segment) for CD, Mayo endoscopic subscore of 0 or 1 for UC * For CD patients with small bowel disease: No ulceration on MRI, only asymptomatic fibrotic stenosis without inflammation and retro dilatation. No ulceration on wireless capsule endoscopy if feasible * For patients with perianal disease: No active draining fistula, or perianal abscess on clinical exam and MRI * Treatment with infliximab at stable dose (5mg/kg) with a stable interval for at least 4 months * Infliximab trough level \> 3 ug/ml * No change in other IBD therapies in the past 4 months * Signed informed consent form * Subjects must be able to attend all scheduled visits and to comply with all trial procedures * Subjects must be covered by public health insurance Exclusion Criteria: * Subject unable to read or/and write * Planned longer stay outside the region that prevents compliance with the visit plan * Subject who are in a dependency or employment with the sponsor or the investigator * Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date * Previous withdrawal or spacing over 8 weeks of infliximab therapy * Infliximab therapy at 10 mg/kg * Patients who have presented a severe acute or delayed reaction to infliximab. * Active perianal/abdominal fistulae at time of inclusion, defined by active drainage * Patients with ostomy or ileoanal pouch * Pregnancy or planned pregnancy during the study * Inability to follow study procedures as judged by the investigator * Steroid use ≤3 months prior to screening

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases

Contacts and locations

Locations

  • APHP Beaujon Hospital

    Paris, France

  • APHP Paris Cochin

    Paris, France

  • Amiens University Hospital

    Amiens, France

  • Besançon University Hospital

    Besançon, France

  • Bordeaux University Hospital

    Bordeaux, France

  • CHRU Nancy - Hôpitaux de Brabois

    Nancy, France

  • Caen University Hospital

    Caen, France

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, France

  • Lille University Hospital

    Lille, France

  • Nantes University Hospital

    Nantes, France

  • Nice University Hospital

    Nice, France

  • Nîmes University Hospital

    Nîmes, France

  • Pineton de Chambrun

    Montpellier, 34000, France

  • Rennes University Hospital

    Rennes, France

  • Saint Etienne University Hospital

    Saint-Etienne, France

  • Toulouse University Hospital

    Toulouse, France

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