Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
Phase 4 · Testing Biological Drug · 28 sites · Universitaire Ziekenhuizen KU Leuven
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Biological Drug (a drug) to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology
- Males and females 18-80 years old.
Plus 11 more requirement(s). There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 292 participants are expected to take part.
- Start date: 2022-09-08.
- Main results expected around 2027-10 (estimate from the record).
- 28 study sites listed (24 marked recruiting) in Belgium and Italy.
Main thing being measured
- postoperative endoscopic recurrence (Rutgeerts score ≥i2b) (86 weeks)
In the researchers’ words
With this prospective, randomized, 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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Enrollment | 292 (estimated) |
| Start date | 2022-09-08 |
| Primary completion (est.) | 2027-10 |
| First posted | 2021-12-27 |
| Last updated | 2026-05-05 |
| Official title | Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease |
| ClinicalTrials.gov ID | NCT05169593 |
Interventions
- Biological Drug (Drug)
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. 2. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology 3. Males and females 18-80 years old. 4. Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit. 5. Patients having an increased risk for postoperative recurrence for any of the following reasons: 1. Penetrating disease as reason for ileocolonic resection 2. Previous ileocolonic resection within ten years of index surgery 3. Two or more previous ileocolonic resections 4. Active smoking 5. Biological therapy for Crohn's disease within 3 months of index ileocolonic resection 6. Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed. 7. Patients previously failing at least three months of steroids and/or three months of immunosuppressive therapy, or showing intolerance or a real contraindication for any of these therapies. 8. Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization Exclusion Criteria: 1. 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.. 2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol. 3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial. 4. Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device. 5. Patients initiating biological therapy for CD as part of another clinical trial or a medical need program. 6. Patients not understanding Dutch, French, German or English. 7. Patients with ulcerative colitis or inflammatory bowel disease type unclassified. 8. Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis. 9. Patients with active perianal disease. 10. Patients with a colorectal stenosis. 11. Patients with an ostomy. 12. Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than ten days after ileocolonic resection or restoration of the faecal stream. 13. Patients with (an imminent risk) of a short bowel syndrome. 14. Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation. 15. Patients with liver test abnormalities (aspartate transaminase, alanine transaminase, alkaline phosphatases, or bilirubin > 2 upper limit of normal), leukopenia (<3000 white blood cells 109/L, <1500 neutrophils 109/L ), thrombocytopenia (platelets < 50.000/mm3). 16. Patients with severe renal, pulmonary or cardiac disease. 17. Ongoing alcohol or substance abuse.
Locations (28)
Show all 28 sites
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Aalst | Aalst | Belgium | Recruiting |
| Imeldaziekenhuis | Bonheiden | Belgium | Recruiting |
| AZ Klina | Brasschaat | Belgium | Recruiting |
| AZ Sint-Jan | Bruges | Belgium | Recruiting |
| AZ Sint Lucas | Ghent | Belgium | Recruiting |
| Jessa ziekenhuis | Hasselt | Belgium | Recruiting |
| AZ Sint Maarten | Mechelen | Belgium | Withdrawn |
| AZ Delta | Roeselare | Belgium | Recruiting |
| Vitaz | Sint-Niklaas | Belgium | Recruiting |
| 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 |
| UZ Leuven | Leuven, Vlaams-Brabant | Belgium | Recruiting |
| Sint lucas Brugge | Bruges, West-Vlaanderen | Belgium | Not yet recruiting |
| AZ Damiaan | Ostend, West-Vlaanderen | Belgium | Recruiting |
| IRCCS De Bellis Castellana Grotte | Castellana Grotte | Italy | Recruiting |
| Careggi University Hospital | Florence | Italy | Recruiting |
| IRCCS San Raffael Hospital | Milan | Italy | Recruiting |
| Humanitas research hospital | Milan, Rozzano MI | Italy | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.