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Computer model aims to optimize infliximab shots for IBD patients

NCT ID NCT07120152

Knowledge-focused Sponsor: Erwin Dreesen 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study uses computer simulations to better understand how a subcutaneous (under-the-skin) form of the drug infliximab works in people with inflammatory bowel disease (IBD) and rheumatoid arthritis. Researchers will analyze data from previous trials to create a model that predicts how the drug is absorbed and affects the body. The goal is to help doctors decide which patients should switch to this convenient injection form and when, but no new treatments are being tested directly on participants.

What this could mean

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

Active substance
subcutaneous infliximab (CT-P13 Remsima®SC)
What this could lead to
If successful, this could help doctors choose the right patients and timing for switching to subcutaneous infliximab, improving treatment convenience and outcomes.
What could go wrong
This is a computer simulation study, not a direct patient trial. The models may not perfectly predict real-world results, and further clinical studies are needed.

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 439 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Mar 2027

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 inflammatory bowel disease

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Crohns disease with a score on the Crohn's disease activity index between 220 and 450. * Patients with active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only) Exclusion Criteria: * Patients who have previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFa)-inhibitor for the treatment of other diseases. * Patients who have allergies to any of the excipients of infliximab or any other murine and/or human proteins or patients with a hypersensitivity to immunoglobulin products. * Patients who have a current or past history of infection with HIV, hepatitis B or C (carriers of hepatitis B and C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled). * Patients who have acute infections requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of the study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug. * Patient who have an indeterminate result for interferon-y release assay (IGRA) or latent tuberculosis (TB) at Screening. For part 2, if IGRA result is indeterminate at the Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease rheumatoid arthritis ulcerative colitis

As listed by the trial registrant

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

IBD (inflammatory bowel disease) RA - rheumatoid arthritis

How to take part

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

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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