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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT03221166
Eligibility Criteria:
Inclusion Criteria:
* Age at diagnosis \<18 years and \>=6 years
* New diagnosis of CD based on Porto criteria
* CD with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for surgery except for perinal fistulas
* Presence of at least one of the following risk factors for poor prognosis:
* fistulizing perianal disease
* pan-enteric disease
* disease extension \> 60 cm
* severe growth delay (height z-score \< -2 DS)
* severe osteoporosis (z score \< -2 DS)
* hypoalbuminemia (\< 3g/dL) or high C-reactive protein (2 times higher the normal range)
* Acceptance of the Risk Evaluation and Mitigation Strategy (REMS) program for reducing the teratogenic risk.
Exclusion Criteria:
* ongoing pregnancy
* presence of peripheral neuropathy
* HIV
* patients with transplanted organs
* ongoing major infections or other severe diseases
* participation to other experimental studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03221166
Study Brief:
Protocol Section:
NCT03221166