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Which biologic best stops Crohn's from coming back after surgery?

NCT ID NCT07694674

Disease control Sponsor: Shanghai 10th People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at whether certain biologic drugs (like infliximab, adalimumab, vedolizumab, and ustekinumab) can prevent Crohn's disease from flaring up again after bowel surgery. Researchers will review medical records of about 198 adults who started one of these drugs within six weeks after surgery. The main goal is to see which drug is best at keeping the disease in remission, based on follow-up colonoscopy results.

What this could mean

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

Active substance
Biologic agents (infliximab, adalimumab, vedolizumab, ustekinumab)
What this could lead to
If one biologic proves more effective, it could help doctors choose the best drug to prevent Crohn's disease from returning after surgery.
What could go wrong
This is a retrospective study, not a controlled trial, so results may be less reliable. The drugs may not prevent recurrence in all patients and carry risks like infection or allergic reactions.

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 198 people

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

Started

Jan 2026

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

This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025. Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation. Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.

Ages

18 to 85 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: * Age ≥18 years. * Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings. * Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection. * Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery. * Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months. * Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence. Exclusion Criteria: * Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy. * Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy. * No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment. * Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate. * Other conditions considered by the investigators to be inappropriate for inclusion.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease Recurrence

As listed by the trial registrant

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

Crohn disease (CD) Inflamatory bowel disease

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  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

  • The Tenth People's Hospital of Shanghai

    RECRUITING

    Shanghai, Shanghai Municipality, 201505, China

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