Crohn DiseasePhase 4SOPRANO-CDNCT05169593
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
A Phase 4 study testing Biological Drug in people with Crohn Disease, run by Universitaire Ziekenhuizen KU Leuven at 28 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Biological Drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 8 Sep 2022to Oct 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 18-80 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 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:
Show all 14Show fewer
- Penetrating disease as reason for ileocolonic resection
- Previous ileocolonic resection within ten years of index surgery
- Two or more previous ileocolonic resections
- Active smoking
- Biological therapy for Crohn's disease 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 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.
- Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization
Who cannot join
- 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 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 or English.
Show all 17Show fewer
- 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.
- Patients with a colorectal stenosis.
- Patients with an ostomy.
- 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.
- Patients with (an imminent risk) of a short bowel syndrome.
- Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.
- 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).
- Patients with severe renal, pulmonary or cardiac disease.
- Ongoing alcohol or substance abuse.
Trial locations and contacts
28 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 2 countries
Belgium24 sites, 23 recruiting
- Recruiting
OLV Aalst
Aalst, 9300
Stijn Vanden Branden, MD, +3253724428, Stijn.Vanden.branden@olvz-aalst.be
- Recruiting
ZAS
Antwerp, Antwerpen, 2018
Filip Couturier, MD, +3232852815, filip.couturier@gza.be
- Recruiting
Imeldaziekenhuis
Bonheiden, 2820
Lieven Pouillon, MD, +3215504969, lieven.pouillon@imelda.be
- Recruiting
AZ Klina
Brasschaat, 2930
Evi Van Dyck, MD, +3236505227, evi.van.dyck@klina.be
- Not yet recruiting
Sint lucas Brugge
Bruges, West-Vlaanderen, 8310
Julie Busschaert, MD, 050365165, Julie.Busschaert@stlucas.be
- Recruiting
AZ Sint-Jan
Bruges, 8000
Barbara Willandt, MD, +3250452180, barbara.willandt@azsintjan.be
- Recruiting
Erasmus ziekenhuis
Brussels, Brussels Capital, 1070
Denis Franchimont, MD, +3225558307, denis.franchimont@erasme.ulb.ac.be
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
Olivier Dewit, MD, +3227642871, Olivier.Dewit@uclouvain.be
- Recruiting
UZA
Edegem, Antwerpen, 2650
Michaël Somers, MD, +3238215584, michael.somers@uza.be
- Recruiting
ZOL Genk
Genk, Limburg, 3600
Evelien Humblet, MD, +3289326515, evelien.humblet@zol.be
- Recruiting
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Didier Baert, MD, +3292467100, didier.baert@azmmsj.be
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Triana Lobaton Ortega, MD, +3293322371, triana.lobatonortega@uzgent.be
- Recruiting
AZ Sint Lucas
Ghent, 9000
Harald Peeters, MD, 092245170, harald.peeters@azstlucas.be
- Recruiting
Jessa ziekenhuis
Hasselt, 3500
Liesbeth Thijs, MD, +3211337619, liesbeth.thijs@jessazh.be
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Liv Vandermeulen, MD, +3224776812, Liv.Vandermeulen@uzbrussel.be
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Marc Ferrante, MD, +3216348856, marc.ferrante@uzleuven.be
Dorien Beeckmans, PhD, +32474474817, dorien.beeckmans@uzleuven.be
- Recruiting
CHC Montlégia
Liège, Liège, 4000
Arnaud Colard, MD, +3243554211, arnaud.colard@chc.be
- Recruiting
CHU de Liège
Liège, Liège, 4000
Edouard Louis, MD, +3243667256, edouard.louis@uliege.be
- Withdrawn
AZ Sint Maarten
Mechelen, 2800
- Recruiting
AZ Damiaan
Ostend, West-Vlaanderen, 8400
Guy Lambrecht, MD, +3259416334, glambrecht@azdamiaan.be
- Recruiting
AZ Delta
Roeselare, 8800
Filip Baert, MD, +3251237215, filip.baert@azdelta.be
- Recruiting
Vitaz
Sint-Niklaas, 9100
Tom Holvoet, MD, +32474926904, tom.holvoet@aznikolaas.be
- Recruiting
CHwapi
Tournai, Henegouwen, 7500
Maxence Lefebvre, MD, +3269331650, maxence.lefebvre@chwapi.be
- Not yet recruiting
CHU UCL Namur site Godinne
Yvoir, Namur, 5530
Jean-Francois rahier, prof, jfrahier@gmail.com
Italy4 sites, 4 recruiting
- Recruiting
IRCCS De Bellis Castellana Grotte
Castellana Grotte, 70013
Mauro Mastronardi, mauro21mastronardi@gmail.com
- Recruiting
Careggi University Hospital
Florence, 50134
Gabriele Dragoni, MD, gabriele.dragoni@unifi.it
- Not yet recruiting
Humanitas research hospital
Milan, Rozzano MI, 20089
Alessandro Armuzzi, Prof, 0282247714, alessandro.armuzzi@hunimed.eu
- Recruiting
IRCCS San Raffael Hospital
Milan, 20132
Silvio Danese, MD, +31226432069, DANESE.SILVIO@HSR.IT
About this study
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
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 include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited.
Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
Read the detailed description
This will be a prospective, randomized, parallel group, pragmatic trial.
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
- Crohn Disease
- Being tested
- Biological Drug
- Keywords
- biological therapy, ileocolonoscopy, ileocolonic resection, ileocolonic anastomosis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological DrugDrug
Also called Risankizumab, Vedolizumab, Ustekinumab, Infliximab
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy-driven postoperative biological therapy | Other | 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. Receives: Drug: Biological Drug |
| Systematic postoperative prophylaxis with a biological | Active comparator | 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. Receives: Drug: Biological Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative endoscopic recurrence (Rutgeerts score ≥i2b)
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
Measured: 86 weeks
need for unscheduled treatment adaptation prior to week 86
When, due to clinical symptoms, therapy needs to be started or switched prior to week 86
Measured: 86 weeks
Secondary outcomes (6)
Harvey Bradshaw Index (HBI) based clinical recurrence
HBI based clinical recurrence (score higher than 4) prior to week 86. HBI based clinical recurrence is defined as HBI >4; AND objective signs of disease recurrence, namely faecal calprotectin >250 µg/g, CRP >5 mg/L, or endoscopic recurrence Rutgeerts score ≥i2b, or clear radiological disease activity at the neo-terminal ileum.
Measured: 86 weeks
Direct costs
Direct costs from Baseline to week 86
Measured: 86 weeks
new ileocolonic resection
Need for a new ileocolonic resection prior to week 86
Measured: 86 weeks
Severe adverse reactions
Severe adverse reactions to biological therapy prior to week 86
Measured: 86 weeks
Serious adverse events
Serious adverse events prior to week 86
Measured: 86 weeks
European Quality of Live Five Dimension Five Level Scale
Quality of life at week 30, week 62 and week 86 in comparison to Baseline (score between 0 and 100; higher score, better quality of life)
Measured: 86 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start8 Sep 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, multicentre, parallel group pragmatic non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ferrante, Professor, Principal investigator, IG/MAAG-DARM-LEVER, UZ Leuven, campus Gasthuisberg, Herestraat 49 3000 Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169593
- Sponsor's protocol ID
- s62015
- Acronym
- SOPRANO-CD
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- SOPRANO-CD / s62015
- Conditions
- Crohn Disease
- Keywords
- biological therapy, ileocolonoscopy, ileocolonic resection, ileocolonic anastomosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited.
Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
Detailed description
This will be a prospective, randomized, parallel group, pragmatic trial.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, multicentre, parallel group pragmatic non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Endoscopy-driven postoperative biological therapy | Other | Drug: Biological DrugEndoscopic 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. |
| Systematic postoperative prophylaxis with a biological | Active comparator | Drug: Biological DrugAdalimumab: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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.
Key exclusion criteria (17 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological DrugAlso: Risankizumab, Vedolizumab, Ustekinumab, InfliximabBiological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence | Drug | Endoscopy-driven postoperative biological therapy, Systematic postoperative prophylaxis with a biological |
Primary outcome
postoperative endoscopic recurrence (Rutgeerts score ≥i2b)
Time frame: 86 weeks
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
need for unscheduled treatment adaptation prior to week 86
Time frame: 86 weeks
When, due to clinical symptoms, therapy needs to be started or switched prior to week 86
6 secondary outcomes
Harvey Bradshaw Index (HBI) based clinical recurrence
Time frame: 86 weeks
Direct costs
Time frame: 86 weeks
new ileocolonic resection
Time frame: 86 weeks
Severe adverse reactions
Time frame: 86 weeks
Serious adverse events
Time frame: 86 weeks
European Quality of Live Five Dimension Five Level Scale
Time frame: 86 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Ferrante, Professor principal investigator
IG/MAAG-DARM-LEVER, UZ Leuven, campus Gasthuisberg, Herestraat 49 3000 Leuven
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biological Drug in people with Crohn Disease, run by Universitaire Ziekenhuizen KU Leuven at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Ferrante, Professor (016 342845 ext. +32, marc.ferrante@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative endoscopic recurrence (Rutgeerts score ≥i2b) (time frame: 86 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.