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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT02472457
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of Crohn Disease using the Revised Porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care.
* Normal Growth Velocity, or Tanner 5
* Steroid-free Remission (Pediatric Crohn Disease Activity Index Score \<10 without the height component) for at least 12 months prior to enrollment
* Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment
* Stool calprotectin \<250µg/g during the preceding 3 months
* Parental/guardian permission (informed consent) and, if appropriate, child assent.
Exclusion Criteria:
* Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist.
* Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT02472457
Study Brief:
Protocol Section:
NCT02472457