Prevention of Postoperative Endoscopic Recurrence with Endoscopy-driven Versus Systematic Biological Therapy
NCT ID: NCT05169593
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
292 participants
INTERVENTIONAL
2022-09-08
2030-10-31
Brief Summary
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Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
Detailed Description
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Prior to study group assignment, the type of biological therapy to be (eventually) used in the postoperative phase will be selected by the treating physician after thorough discussion with the patient. The use of cheaper anti-TNF biosimilars will be encouraged, but patients who received adalimumab and/or infliximab preoperatively cannot receive the same treatment again in SOPRANO CD if the participants previously encountered immunogenicity issues to this treatment.
Systematic postoperative prophylaxis with a biological:
Biological therapy (adalimumab, infliximab, ustekinumab, vedolizumab or risankizumab) will be initiated within 14 to 40 days after ileocolonic resection or restoration of the faecal stream (day 0).
In patients with both Harvey-Bradshaw Index (HBI) based clinical recurrence (HBI \>4) and endoscopic recurrence (Rutgeerts score ≥i2b) at week 30, biological therapy will be optimized (reimbursed or through the available free goods / samples programs).
Beyond week 32 optimization of this biological therapy will be allowed following daily clinical practice including proactive therapeutic drug monitoring. However, the timing, type and reason for dose optimization should be recorded.
Endoscopy-driven postoperative biological therapy:
No CD related therapy will be administered between Baseline (14 to 40 days after ileocolonic resection or restoration of the faecal stream) and the endoscopic evaluation at week 30 Patients with endoscopic recurrence (Rutgeerts score ≥i2b) at week 30 will initiate biological therapy (adalimumab, infliximab, ustekinumab, vedolizumab or risankizumab) following a classical induction and maintenance schedule. The type of biological therapy has to be decided already in the perioperative phase to allow a proper stratification.
In patients initiating biological therapy at week 30, this therapy maybe optimized from week 32 onwards following daily clinical practice including proactive therapeutic drug monitoring. However, the timing, type and reason for dose optimization should be recorded.
In patients not on biological therapy yet but developing clinical recurrence (HBI \>4) with objective signs of disease recurrence (faecal calprotectin \>250 µg/g, C-reactive protein \>5 mg/L or endoscopic recurrence ≥i2b or clear radiological disease activity at the neo-terminal ileum) beyond week 32, biological therapy can be initiated, but this will be regarded as a study failure.
Randomization:
Eligible patients will be allocated to one of the two treatment arms (1:1) according to a computer generated randomisation list in REDCap.
Stratified randomisation will be performed to achieve approximate balance for:
* Type of selected postoperative prophylactic therapy: adalimumab, infliximab, ustekinumab, vedolizumab or risankizumab.
* Number of risk factors for postoperative recurrence: 1, 2 or \>2 (out of 5 predefined factors: active smoking, penetrating disease, previous ileocolonic resection ≤10 years of index surgery, ≥2 previous ileocolonic resections, biological therapy ≤3 months of index ileocolonic resection)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Endoscopy-driven postoperative biological therapy
Endoscopic recurrence at week 30
Adalimumab: 160 mg SC at week 32, 80 mg SC at week 34, 40 mg SC at week 36 and every two weeks thereafter.
Infliximab: Induction with 5 mg/kg IV at week 32, and 5 mg/kg IV at week 34; maintenance with 5 mg/kg IV at week 38, week 42 or week 46 and every eight weeks thereafter or with 120 mg SC at week 38 and every two weeks thereafter.
Ustekinumab: 260 mg (body weight ≤55kg) or 390 mg (55-85kg) or 520 mg (\>85kg) IV at week 32, 90 mg SC at week 40, and every eight weeks thereafter.
Vedolizumab: Induction with 300 mg IV at week 32, and 300 mg IV at week 34; maintenance with 300 mg IV at week 38 and every eight weeks thereafter or with 108 mg SC at week 38, week 42 or week 46 and every two weeks thereafter.
Risankizumab: Induction with 600 mg IV at week 32, week 36 and week 40; maintenance with 360 mg SC at week 44 and every eight weeks thereafter.
Biological Drug
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Systematic postoperative prophylaxis with a biological
Adalimumab: 160 mg subcutaneous (SC) at day 0, 80 mg SC at week 2, 40 mg SC at week 4 and every two weeks thereafter.
Infliximab: Induction with 5 mg/kg intravenous (IV) at day 0, and 5 mg/kg IV at week 2; maintenance with 5 mg/kg IV at week 6, week 10 or week 14 and every eight weeks thereafter or with 120 mg SC at week 6 and every two weeks thereafter.
Ustekinumab: 260 mg (body weight ≤55kg), 390 mg (55-85kg) or 520 mg (\>85kg) IV at day 0, 90 mg SC at week 8 and every eight weeks thereafter.
Vedolizumab: Induction with 300 mg IV at day 0, and 300 mg IV at week 2; maintenance with 300 mg IV at week 6 and every eight weeks thereafter or with 108 mg SC at week 6, week 10 or week 14 and every two weeks thereafter.
Risankizumab: Induction with 600 mg IV at day 0, week 4 and week 8; maintenance with 360 mg SC at week 12 and every eight weeks thereafter.
Biological Drug
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Interventions
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Biological Drug
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Marc Ferrante, Professor
Role: PRINCIPAL_INVESTIGATOR
IG/MAAG-DARM-LEVER, UZ Leuven, campus Gasthuisberg, Herestraat 49 3000 Leuven
Locations
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GZA
Antwerp, Antwerpen, Belgium
UZA
Edegem, Antwerpen, Belgium
Erasmus ziekenhuis
Brussels, Brussels Capital, Belgium
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, Belgium
UZ Brussel
Jette, Brussels Capital, Belgium
CHwapi
Tournai, Henegouwen, Belgium
ZOL Genk
Genk, Limburg, Belgium
CHC Montlégia
Liège, Liège, Belgium
CHU de Liège
Liège, Liège, Belgium
CHU UCL Namur site Godinne
Yvoir, Namur, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Sint lucas Brugge
Bruges, West-Vlaanderen, Belgium
AZ Damiaan
Ostend, West-Vlaanderen, Belgium
OLV Aalst
Aalst, , Belgium
Imeldaziekenhuis
Bonheiden, , Belgium
AZ Klina
Brasschaat, , Belgium
AZ Sint-Jan
Bruges, , Belgium
AZ Sint Lucas
Ghent, , Belgium
Jessa ziekenhuis
Hasselt, , Belgium
AZ Sint Maarten
Mechelen, , Belgium
AZ Delta
Roeselare, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Humanitas research hospital
Milan, Rozzano MI, Italy
IRCCS De Bellis Castellana Grotte
Castellana Grotte, , Italy
Careggi University Hospital
Florence, , Italy
IRCCS San Raffael Hospital
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Filip Couturier, MD
Role: primary
Michaël Somers, MD
Role: primary
Denis Franchimont, MD
Role: primary
Olivier Dewit, MD
Role: primary
Liv Vandermeulen, MD
Role: primary
Maxence Lefebvre, MD
Role: primary
Evelien Humblet, MD
Role: primary
Arnaud Colard, MD
Role: primary
Edouard Louis, MD
Role: primary
Jean-Francois rahier, prof
Role: primary
Didier Baert, MD
Role: primary
Triana Lobaton Ortega, MD
Role: primary
Marc Ferrante, MD
Role: primary
Dorien Beeckmans, PhD
Role: backup
Julie Busschaert, MD
Role: primary
Guy Lambrecht, MD
Role: primary
Stijn Vanden Branden, MD
Role: primary
Lieven Pouillon, MD
Role: primary
Evi Van Dyck, MD
Role: primary
Barbara Willandt, MD
Role: primary
Harald Peeters, MD
Role: primary
Liesbeth Thijs, MD
Role: primary
Jurgen Van Dongen, MD
Role: primary
Filip Baert, MD
Role: primary
Tom Holvoet, MD
Role: primary
Alessandro Armuzzi, Prof
Role: primary
Mauro Mastronardi
Role: primary
Gabriele Dragoni, MD
Role: primary
Silvio Danese, MD
Role: primary
Other Identifiers
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s62015
Identifier Type: -
Identifier Source: org_study_id