Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06666569
Eligibility Criteria:
Inclusion criteria:
* patients of both sexes
* over 18 years of age
* diagnosis of CD/CU confirmed by endoscopy
* stable clinical status (remission) for at least 12 weeks prior to inclusion in the study
* on treatment with IFX/ADL for at least 3 months with stabilized dosage and outside the induction period
* negative for tuberculosis at the start of treatment
* who sign the informed consent form
Exclusion criteria:
* severe concomitant pathology preventing adequate follow-up of patients.
* continued corticosteroid therapy at prednisone equivalent doses higher than 40 mg/day
* patients with positive antibody levels at baseline
* there is treatment with immunomodulators and/or corticoids, when it is at high doses and with variations in time
* Patients with intestinal resection and Crohn's disease in prophylactic treatment with anti-TNF, but without recurrence.
* who are participating in a clinical trial or interventional study. Participation in the study will be offered to all patients who meet the above criteria, and in a consecutive manner, without a prior selection process. The comparison group will consist of a cohort of patients belonging to the same Digestive Services and meeting the same selection criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06666569
Study Brief:
Protocol Section:
NCT06666569