Crohn'sRecruiting
The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.
Observational · No treatment assigned · 2 sites · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn´s Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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;
Plus 2 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2023-06-05.
- Main results expected around 2027-01-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Canada and Netherlands.
Main thing being measured
- Changes in concentration and amounts of IL-23 responsive cells in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent. (Week 16)
In the researchers’ words
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 large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn´s Disease |
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Enrollment | 40 (estimated) |
| Start date | 2023-06-05 |
| Primary completion (est.) | 2027-01-01 |
| First posted | 2023-08-23 |
| Last updated | 2025-10-03 |
| Official title | An Explorative Study to Examine the Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease. |
| ClinicalTrials.gov ID | NCT06006039 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai | Toronto, Ontario | Canada | Recruiting |
| Amsterdam UMC | Amsterdam, North Holland | Netherlands | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.