Authorised Therapeutic use (Phase IV) Patients with Crohn's disease undergoing surgery and having at least one risk factor for postoperative recurrence of the disease.

Prevention of postoperative endoscopic disease recurrence in Crohn’s disease: a multicentric study that compares the systematic start of biological therapy immediately after an ileocolonic resection with the start of biological therapy in patients with endoscopic recurrence six months after ileocolonic resection

EU CTIS ID: 2022-500311-39-00

What this study is testing

To compare the postoperative endoscopic recurrence rate in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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 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 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.
Patients having an increased risk for postoperative recurrence for any of the following reasons: a) Penetrating disease as reason for ileocolonic resection; b) Previous ileocolonic resection within ten years of index surgery; c) Two or more previous ileocolonic resections aside from the index ileocolonic resection; d) Active smoking (i.e. smoked at least 7 sigarets during the past month); e) Advanced therapy (including biological therapy and small molecules) within 3 months of index ileocolonic resection.
Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed.

You likely can't join if

Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
Patients with a colorectal stenosis.
Patients with an ostomy.
Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than 15 days after ileocolonic resection or restoration of the faecal stream.
Patients with (an imminent risk) of a short bowel syndrome.
Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.

See the full eligibility criteria

Who can join

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 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 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.
Patients having an increased risk for postoperative recurrence for any of the following reasons: a) Penetrating disease as reason for ileocolonic resection; b) Previous ileocolonic resection within ten years of index surgery; c) Two or more previous ileocolonic resections aside from the index ileocolonic resection; d) Active smoking (i.e. smoked at least 7 sigarets during the past month); e) Advanced therapy (including biological therapy and small molecules) within 3 months of index ileocolonic resection.
Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed.
Patients previously failing (for Belgium: 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. Local reimbursement criteria should be followed at all times.
Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization.

What rules you out

Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
Patients with a colorectal stenosis.
Patients with an ostomy.
Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than 15 days after ileocolonic resection or restoration of the faecal stream.
Patients with (an imminent risk) of a short bowel syndrome.
Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.
Participant has a history of primary non-response, secondary loss of response, intolerance or contraindication to all seven biological therapies of interest, namely adalimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab and vedolizumab.
Any other factors that might jeopardise the participant’s safety or integrity of the trial (e.g. non-compliant patients).
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 interventional 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, Italian or English.
Patients with ulcerative colitis or inflammatory bowel disease type unclassified.
Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis.
Patients with active perianal disease.
Females who are pregnant or nursing at the moment of Screening.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.