RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Biological Drug for Crohn Disease

With this prospective, randomly assigned, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious side effects, direct costs, work productivity, and quality of life.

Official registry: https://clinicaltrials.gov/study/NCT05169593 · Universitaire Ziekenhuizen KU Leuven · enrollment listed as 292

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biological Drug. The registry lists allocation as randomized. With this prospective, randomly assigned, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis.

They plan to enroll about 292 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease

Interventions: Biological Drug

Primary outcome (registry wording): postoperative endoscopic recurrence (Rutgeerts score ≥i2b)

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology
Males and females 18-80 years old
Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit
Patients having an increased risk for postoperative recurrence for any of the following reasons:
Penetrating disease as reason for ileocolonic resection
Previous ileocolonic resection within ten years of index surgery
Two or more previous ileocolonic resections

Who the registry excludes

Participant has a history of primary non response or secondary loss of response to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab.
Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
Participation in an treatment Trial with an Investigational Medicinal Product (IMP) or device
Patients initiating biological therapy for CD as part of another clinical trial or a medical need program
Patients not understanding Dutch, French, German or English
Patients with ulcerative colitis or inflammatory bowel disease type unclassified

Public study contact (from the registry)

Marc Ferrante, Professor

016 342845

marc.ferrante@uzleuven.be

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

28 listed

ZAS — Antwerp, Antwerpen, Belgium (recruiting)
UZA — Edegem, Antwerpen, Belgium (recruiting)
Erasmus ziekenhuis — Brussels, Brussels Capital, Belgium (recruiting)
Cliniques Universitaires Saint Luc — Brussels, Brussels Capital, Belgium (recruiting)
UZ Brussel — Jette, Brussels Capital, Belgium (recruiting)
CHwapi — Tournai, Henegouwen, Belgium (recruiting)
ZOL Genk — Genk, Limburg, Belgium (recruiting)
CHC Montlégia — Liège, Liège, Belgium (recruiting)
CHU de Liège — Liège, Liège, Belgium (recruiting)
CHU UCL Namur site Godinne — Yvoir, Namur, Belgium (not_yet_recruiting)
AZ Maria Middelares — Ghent, Oost-Vlaanderen, Belgium (recruiting)
UZ Gent — Ghent, Oost-Vlaanderen, Belgium (recruiting)

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FAQ about this NCT record

Is NCT05169593 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05169593?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05169593?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary