Humira (adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- University of California, San Diego
- Enrollment
- 944
- Locations
- 1
- Primary Endpoint
- Major malformations
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Investigators
Christina Chambers
Principal Investigator, Professor Department of Pediatrics
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •Currently pregnant
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major malformations
Time Frame: Throughout pregnancy and up to 1 year of life
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.
Secondary Outcomes
- Pregnancy outcome(Throughout pregnancy)
- Infant follow-up(Throughout pregnancy and up to 1 year of life)
- Minor malformations(At dysmorphological exam)