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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT02522169
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients of both sexes with Cohn's disease
* Assured diagnosis of Cohn's disease according to the Porto criteria
* Regular attendance of gastroenteric consultations at one of the study centers
* Minimum patients age of 6 years, maximum age of 16 years
* Infliximab therapy with permitted / without co- medication
* Completed induction with Infliximab in accordance to the approved conventional scheme with primary therapy response
* Written consent of the patient and the legal guardian
Exclusion Criteria:
* No consent of the patient and / or legal guardian
* Serious side effects under Infliximab therapy in the past
* Primary non-responder to Infliximab after first three cycles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT02522169
Study Brief:
Protocol Section:
NCT02522169