Phase
Condition
N/ATreatment
Biological Drug
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures.
Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/orhistology
Males and females 18-80 years old.
Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with orwithout temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with atemporary ileostomy are also eligible if the ileocolonic resection was performedwithin eight months prior to the Screening visit, and the restoration of the faecalstream was performed within 3 and 40 days prior to the Screening visit.
Patients having an increased risk for postoperative recurrence for any of thefollowing 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 ileocolonicresection
Curative ileocolonic resection. All inflamed colon segments should have beenremoved. Strictureplasties in the small bowel not involving the anastomotic regionare allowed.
Patients previously failing at least three months of steroids and/or three months ofimmunosuppressive therapy, or showing intolerance or a real contraindication for anyof these therapies.
Patients able and willing to start and continue biological therapy, and this at thetimepoint indicated through study randomization
Exclusion
Exclusion Criteria:
Participant has a history of primary non response or secondary loss of response toall five biological therapies of interest, namely adalimumab, infliximab,ustekinumab, vedolizumab and risankizumab..
Any disorder, which in the Investigator's opinion might jeopardise the participant'ssafety or compliance with the protocol.
Any prior or concomitant treatment(s) that might jeopardise the participant's safetyor 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 amedical 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 ofantibiotics for more than ten days after ileocolonic resection or restoration of thefaecal stream.
Patients with (an imminent risk) of a short bowel syndrome.
Patients who had qualifying ileocolonic resection for dysplasia or cancer withoutongoing inflammation.
Patients with liver test abnormalities (aspartate transaminase, alaninetransaminase, 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.
Study Design
Study Description
Connect with a study center
UZA
Edegem, Antwerpen 2650
BelgiumActive - Recruiting
AZ Turnhout
Turnhout, Antwerpen 2300
BelgiumSite Not Available
UZ Brussel
Jette, Brussel 1090
BelgiumActive - Recruiting
CHwapi
Tournai, Henegouwen 7500
BelgiumActive - Recruiting
ZOL Genk
Genk, Limburg 3600
BelgiumActive - Recruiting
CHU UCL Namur site Godinne
Yvoir, Namur 5530
BelgiumSite Not Available
AZ Maria Middelares
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Sint lucas Brugge
Brugge, West-Vlaanderen 8310
BelgiumSite Not Available
AZ Damiaan
Oostende, West-Vlaanderen 8400
BelgiumActive - Recruiting
OLV Aalst
Aalst, 9300
BelgiumActive - Recruiting
GZA
Antwerpen, 2018
BelgiumActive - Recruiting
Imeldaziekenhuis
Bonheiden, 2820
BelgiumActive - Recruiting
AZ Klina
Brasschaat, 2930
BelgiumActive - Recruiting
AZ Sint-Jan
Brugge, 8000
BelgiumActive - Recruiting
Cliniques Universitaires Saint Luc
Brussel, 1200
BelgiumActive - Recruiting
Erasmus ziekenhuis
Brussel, 1070
BelgiumActive - Recruiting
AZ Sint Lucas
Gent, 9000
BelgiumActive - Recruiting
Jessa ziekenhuis
Hasselt, 3500
BelgiumActive - Recruiting
CHC Montlégia
Liège, 4000
BelgiumActive - Recruiting
CHU de Liège
Liège, 4000
BelgiumActive - Recruiting
AZ Sint Maarten
Mechelen, 2800
BelgiumActive - Recruiting
AZ Delta
Roeselare, 8800
BelgiumActive - Recruiting
Vitaz
Sint-Niklaas, 9100
BelgiumActive - Recruiting
Humanitas research hospital
Milano, Rozzano Mi 20089
ItalySite Not Available
IRCCS De Bellis Castellana Grotte
Castellana Grotte, 70013
ItalyActive - Recruiting
Careggi University Hospital
Firenze, 50134
ItalyActive - Recruiting
IRCCS San Raffael Hospital
Milano, 20132
ItalyActive - Recruiting
Azienda Ospedale Universita di padova
Padova, 35128
ItalySite Not Available
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