Status:
RECRUITING
The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Crohn´s Disease
Eligibility:
All Genders
18+ years
Brief Summary
Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs...
Eligibility Criteria
Inclusion
- Age \>/= 18 years;
- Male or non-pregnant, non-lactating females;
- Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score \>i2a) in the neoterminal ileum;
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements;
- The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion
- Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures;
- Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association \[NYHA\], multiple sclerosis, active infections).
- Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- Currently participating or planning to participate in a study involving an investigational product.
- Active or planned pregnancy during the study.
- Prior diagnosis of dysplasia in the colon (excluding in resected adenomas).
- History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer.
- Received a biologic treatment between surgery and first endoscopy.
- Positive Clostridium difficile toxin B in faeces. Patients who test positive can be treated per local practice and still enter the study if no longer than 4 weeks after the screening visit, they test negative for Clostridium difficile toxin B.
- Presence of a stoma without ileocolonic anastomosis or pouch.
- Active perianal abscess or draining fistula
- ALT or AST \> 3x the upper limit of normal measured at screening
- Increased risk of bleeding: coagulation disorder, use of anticoagulants and DOACs
Key Trial Info
Start Date :
June 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06006039
Start Date
June 5 2023
End Date
November 1 2027
Last Update
October 3 2025
Active Locations (2)
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1
Mount Sinai
Toronto, Ontario, Canada, 1X5
2
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105