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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT02617927
Eligibility Criteria:
Inclusion Criteria for the UC/CD Prospective Cohort:
* The subject is a currently pregnant woman with UC or CD
* The subject has exposure to Entyvio or other biologic agents or conventional therapy (non-biological therapy) at any dose, and at any time from first day of LMP, The subject enrolls no later than 19 completed weeks after LMP.
* All pregnancies in Entyvio users will be included in the study. Those recruited prior to Week 20 will be entered into the prospective registry, and those recruited after week 20 (included retrospective reports after delivery) will be entered into the separate Case Series.
* The subject agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.
Exclusion Criteria for the UC/CD Prospective Cohort:
* The subject is \>19 completed weeks gestation prior to enrollment,
* The subject has first contact with OTIS after prenatal diagnosis of any major structural defect,
* The subject has enrolled in this registry with a previous pregnancy,
* The subject has had an exposure to the known or suspected human teratogens:
* Chlorambucil
* Cyclophosphamide
* Mycophenylate mofetil
Any Entyvio exposed mother who does not meet the entry criteria will be entered into an Entyvio case series, which will be used to provide support data to cohort study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02617927
Study Brief:
Protocol Section:
NCT02617927