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Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy (SOPRANO-CD)

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Biological Drug
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring biological therapy, ileocolonoscopy, ileocolonic resection, ileocolonic anastomosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZARecruiting
  • AZ TurnhoutRecruiting
  • UZ BrusselRecruiting
  • CHwapiRecruiting
  • ZOL GenkRecruiting
  • AZ Maria MiddelaresRecruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • OLV AalstRecruiting
  • GZARecruiting
  • ImeldaziekenhuisRecruiting
  • AZ KlinaRecruiting
  • AZ Sint-JanRecruiting
  • Erasmus ziekenhuisRecruiting
  • Cliniques Universitaires Saint LucRecruiting
  • AZ Sint LucasRecruiting
  • Jessa ziekenhuisRecruiting
  • CHC MontlégiaRecruiting
  • CHU de LiègeRecruiting
  • AZ Sint MaartenRecruiting
  • AZ DeltaRecruiting
  • VitazRecruiting
  • IRCCS De Bellis Castellana Grotte
  • Careggi University HospitalRecruiting
  • IRCCS San Raffael Hospital
  • Azienda Ospedale Universita di padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Endoscopy-driven postoperative biological therapy

Systematic postoperative prophylaxis with a biological

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
Direct costs
Direct costs from Baseline to week 86
new ileocolonic resection
Need for a new ileocolonic resection prior to week 86
Severe adverse reactions
Severe adverse reactions to biological therapy prior to week 86
Serious adverse events
Serious adverse events prior to week 86
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)

Full Information

First Posted
November 8, 2021
Last Updated
May 11, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05169593
Brief Title
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
Acronym
SOPRANO-CD
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
biological therapy, ileocolonoscopy, ileocolonic resection, ileocolonic anastomosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized, multicentre, parallel group pragmatic non-inferiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopy-driven postoperative biological therapy
Arm Type
Other
Arm Description
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.
Arm Title
Systematic postoperative prophylaxis with a biological
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Biological Drug
Other Intervention Name(s)
Risankizumab, Vedolizumab, Ustekinumab, Infliximab, Adalimumab
Intervention Description
Biological therapy used in daily clinical practice in patients with Crohn's disease to prevent disease recurrence
Primary Outcome Measure Information:
Title
postoperative endoscopic recurrence (Rutgeerts score ≥i2b)
Description
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
Time Frame
86 weeks
Title
need for unscheduled treatment adaptation prior to week 86
Description
When, due to clinical symptoms, therapy needs to be started or switched prior to week 86
Time Frame
86 weeks
Secondary Outcome Measure Information:
Title
Harvey Bradshaw Index (HBI) based clinical recurrence
Description
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.
Time Frame
86 weeks
Title
Direct costs
Description
Direct costs from Baseline to week 86
Time Frame
86 weeks
Title
new ileocolonic resection
Description
Need for a new ileocolonic resection prior to week 86
Time Frame
86 weeks
Title
Severe adverse reactions
Description
Severe adverse reactions to biological therapy prior to week 86
Time Frame
86 weeks
Title
Serious adverse events
Description
Serious adverse events prior to week 86
Time Frame
86 weeks
Title
European Quality of Live Five Dimension Five Level Scale
Description
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)
Time Frame
86 weeks
Other Pre-specified Outcome Measures:
Title
Crohn's disease activity index (CDAI) based clinical recurrence
Description
CDAI based clinical recurrence prior and at week 86 and time to CDAI based clinical recurrence
Time Frame
86 weeks
Title
Harvey Bradshaw Index (HBI score higher than 4) based clinical recurrence
Description
HBI based clinical recurrence at week 86 and time to HBI based clinical recurrence. 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 ≥i2b, or clear radiological disease activity at the neo-terminal ileum.
Time Frame
86 weeks
Title
Two-component Patient Reported Outcome (PRO-2) based clinical recurrence
Description
PRO-2 based clinical recurrence prior and at week 86 and time to PRO-2 clinical recurrence. PRO-2 based clinical recurrence is defined as average liquid or very soft stool frequency of >2.8 and/or abdominal pain score >1.0
Time Frame
86 weeks
Title
Endoscopic disease activity
Description
Endoscopic disease activity (Rutgeerts score ≥i3, ≥i2a, or ≥i1) at week 86
Time Frame
86 weeks
Title
Endoscopic recurrence
Description
Endoscopic recurrence (Rutgeerts score ≥i2b) at week 30
Time Frame
30 weeks
Title
Endoscopic disease activity
Description
Endoscopic disease activity (Rutgeerts score ≥i3, ≥i2a, or ≥i1) at week 30
Time Frame
30 weeks
Title
Persistent endoscopic recurrence
Description
Persistent endoscopic recurrence at week 86 after development of endoscopic recurrence at week 30
Time Frame
86 weeks
Title
a new ileocolonic resection, a balloon dilation or a strictureplasty
Description
Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 86
Time Frame
86 weeks
Title
Work Productivity and Activity Impairment in Crohn's Disease questionnaire
Description
Work productivity and activity impairment at week 30, week 62 and week 86 in comparison to Baseline (score between 0 and 20; lower score, better outcome)
Time Frame
86 weeks
Title
Change in medical therapy
Description
Change in medical therapy for Crohn's disease prior to week 86
Time Frame
86 weeks
Title
Change in C-reactive protein
Description
Change CRP at week 14, week 30, week 46, week 62 and week 86 in comparison to baseline
Time Frame
86 weeks
Title
Change in faecal calprotectin
Description
Change in faecal calprotectin at week 14, week 30, week 46, week 62 and week 86 in comparison to baseline
Time Frame
86 weeks
Title
unscheduled visits
Description
Number of unscheduled visits related to CD (clinical visit, endoscopic or radiological evaluation)
Time Frame
86 weeks
Title
Suspected unexpected serious adverse reactions
Description
Suspected unexpected serious adverse reactions prior to week 86
Time Frame
86 weeks
Title
Two-component Patient Reported Outcome (PRO-2) based clinical recurrence in longterm follow-up
Description
Evolution of PRO-2 at week 138, 190 and 242 in comparison to Baseline and Week 86
Time Frame
242 weeks
Title
European Quality of Live Five Dimension Five Level Scale in longterm follow-up
Description
Evolution of EQ-5D 5L at week 138, 190 and 242 in comparison to Baseline and Week 86
Time Frame
242 weeks
Title
Work Productivity and Activity Impairment in Crohn's Disease questionnaire in longterm follow-up
Description
Evolution of WPAI:CD at week 138, 190 and 242 in comparison to Baseline and Week 86
Time Frame
242 weeks
Title
Change in C-reactive protein in longterm follow-up
Description
Evolution of CRP at week 138, 190 and 242 in comparison to Baseline and Week 86
Time Frame
242 weeks
Title
Change in faecal calprotectin in longterm follow-up
Description
Evolution of faecal calprotectin at week 138, 190 and 242 in comparison to Baseline and Week 86
Time Frame
242 weeks
Title
Change in medical therapy in longterm follow-up
Description
Change in medical therapy for Crohn's disease prior to week 138, 190 and 242
Time Frame
242 weeks
Title
a new ileocolonic resection, a balloon dilation or a strictureplasty in longterm follow-up
Description
Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 138, 190 and 242
Time Frame
242 weeks
Title
Severe adverse reactions in longterm follow-up
Description
Severe adverse reactions to biological therapy prior to week 138, 190 and 242
Time Frame
242 weeks
Title
Serious adverse events in longterm follow-up
Description
Serious adverse events prior to week 138, 190 and 242
Time Frame
242 weeks
Title
Suspected unexpected serious adverse reactions in longterm follow-up
Description
Suspected unexpected serious adverse reactions prior to week 138, 190 and 242
Time Frame
242 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Ferrante, Professor
Phone
016 342845
Ext
+32
Email
marc.ferrante@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dorien Beeckmans, PhD
Phone
016 348545
Ext
+32
Email
dorien.beeckmans@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ferrante, Professor
Organizational Affiliation
IG/MAAG-DARM-LEVER, UZ Leuven, campus Gasthuisberg, Herestraat 49 3000 Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZA
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaël Somers, MD
Phone
+3238215584
Email
michael.somers@uza.be
Facility Name
AZ Turnhout
City
Turnhout
State/Province
Antwerpen
ZIP/Postal Code
2300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Claessens, MD
Phone
+3214444440
Email
Christophe.Claessens@azturnhout.be
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liv Vandermeulen, MD
Phone
+3224776812
Email
Liv.Vandermeulen@uzbrussel.be
Facility Name
CHwapi
City
Tournai
State/Province
Henegouwen
ZIP/Postal Code
7500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxence Lefebvre, MD
Phone
+3269331650
Email
maxence.lefebvre@chwapi.be
Facility Name
ZOL Genk
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelien Humblet, MD
Phone
+3289326515
Email
evelien.humblet@zol.be
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Baert, MD
Phone
+3292467100
Email
didier.baert@azmmsj.be
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Triana Lobaton Ortega, MD
Phone
+3293322371
Email
triana.lobatonortega@uzgent.be
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Ferrante, MD
Phone
+3216348856
Email
marc.ferrante@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Dorien Beeckmans, PhD
Phone
+32474474817
Email
dorien.beeckmans@uzleuven.be
Facility Name
OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stijn Vanden Branden, MD
Phone
+3253724428
Email
Stijn.Vanden.branden@olvz-aalst.be
Facility Name
GZA
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Couturier, MD
Phone
+3232852815
Email
filip.couturier@gza.be
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieven Pouillon, MD
Phone
+3215504969
Email
lieven.pouillon@imelda.be
Facility Name
AZ Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evi Van Dyck, MD
Phone
+3236505227
Email
evi.van.dyck@klina.be
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Willandt, MD
Phone
+3250452180
Email
barbara.willandt@azsintjan.be
Facility Name
Erasmus ziekenhuis
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Franchimont, MD
Phone
+3225558307
Email
denis.franchimont@erasme.ulb.ac.be
Facility Name
Cliniques Universitaires Saint Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Dewit, MD
Phone
+3227642871
Email
Olivier.Dewit@uclouvain.be
Facility Name
AZ Sint Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Peeters, MD
Phone
092245170
Email
harald.peeters@azstlucas.be
Facility Name
Jessa ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Thijs, MD
Phone
+3211337619
Email
liesbeth.thijs@jessazh.be
Facility Name
CHC Montlégia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Colard, MD
Phone
+3243554211
Email
arnaud.colard@chc.be
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Louis, MD
Phone
+3243667256
Email
edouard.louis@uliege.be
Facility Name
AZ Sint Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurgen Van Dongen, MD
Phone
+3215893813
Email
jurgen.van.dongen@emmaus.be
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Baert, MD
Phone
+3251237215
Email
filip.baert@azdelta.be
Facility Name
Vitaz
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Holvoet, MD
Phone
+32474926904
Email
tom.holvoet@aznikolaas.be
Facility Name
IRCCS De Bellis Castellana Grotte
City
Castellana Grotte
ZIP/Postal Code
70013
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Mastronardi
Email
mauro21mastronardi@gmail.com
Facility Name
Careggi University Hospital
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Dragoni, MD
Email
gabriele.dragoni@unifi.it
Facility Name
IRCCS San Raffael Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD
Phone
+31226432069
Email
DANESE.SILVIO@HSR.IT
Facility Name
Azienda Ospedale Universita di padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edoardo Savarino, MD
Email
edoardosavarino@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy

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