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IBD patients may ditch IV drips for simple shots

NCT ID NCT06381518

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested switching 38 adults with inflammatory bowel disease (Crohn's or ulcerative colitis) from intravenous infliximab to a subcutaneous (under-the-skin) injection. Researchers measured drug levels, quality of life, and patient satisfaction over 24 weeks. The goal was to see if the switch maintains effectiveness while being more convenient.

What this could mean

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

Active substance
infliximab (CT-P13, a biosimilar) given as a subcutaneous injection
What this could lead to
If successful, this could show that switching to a subcutaneous injection is just as effective and more convenient for patients with inflammatory bowel disease.
What could go wrong
This is a small, single-center study with only 38 patients, so results may not apply to everyone. The switch might not work as well for some patients, and there is a risk of injection site reactions or loss of effectiveness.

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

38 people

The number who actually took part.

Started

Mar 2024

Finished

Dec 2025

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 to 75 years

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: * Adult patients (18-75 years) with an confirmed diagnosis of IBD according to usual criteria, including previous endoscopic examination. * Patients on IV IFX maintenance therapy at a stable dose and dosing interval for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX. * IBD in clinical remission for at least 16 weeks without treatment with systemic corticosteroids in the previous 16 weeks. Clinical remission in adult patients is defined as a Harvey-Bradshaw index (HBI) \< 4 for CD \[18\] or a partial Mayo Index (PMI) \<2 for UC \[19\], with faecal calprotectin levels \<250 μg/g faeces and CRP \<10 mg/L. * Concomitant immunomodulators are allowed, i.e. in stable doses were received for at least 12 weeks prior to study enrolment. These doses will be continued throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP), tioguanine (TG) and MTX. * Written informed consent Exclusion Criteria: * Patient \<18 years of age. * Allergy or hypersensitivity to any of the excipients of SC CT-P13. * Patient with active perianal fistula. * Patient with another autoimmune disease in addition to IBD. * Patient treated concomitantly with another Mab in addition to IFX. * Patients who, after starting IV IFX, have developed new contraindications to IFX according to European Public Assessment Report (EPAR).\[3\] * Female patient who is currently pregnant or breastfeeding, or is planning to become pregnant or breastfeed within 6 months of the last dose of IFX. * Patient has a serious acute or chronic medical or psychiatric condition that might increase the risk associated with study participation or investigational product administration or that might interfere with the interpretation of study results. * Patients who, in the opinion of their general practitioner or investigator, should not participate in the study (e.g. non-adherence, mental health problems, illiteracy).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Zuyderland Medical Centre

    Sittard, Netherlands

More trials for these conditions

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