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:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT05242458
Eligibility Criteria:
Inclusion Criteria:
* Having at least one ICN visit with documented new use of ustekinumab
* Participants with a documented Crohn's disease (CD) diagnosis at the time ustekinumab was initiated (that is, Baseline); If diagnosis at baseline is missing, then the diagnosis from previous visit within study window will be utilized
* Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
* Having received first dose of ustekinumab on or before June 22, 2019
* Having provided informed consent for use of ICN data for research purposes
Exclusion Criteria:
* Documented exposure to ustekinumab before enrollment in ICN (by chart review)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
25 Years
Study:
NCT05242458
Study Brief:
Protocol Section:
NCT05242458