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Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
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.
Details
| Lead sponsor | University of California, San Diego |
|---|---|
| Status | COMPLETED |
| Enrolment | 944 |
| Start date | 2003-11 |
| Completion | 2019-10 |
Conditions
- Crohn's Disease
- Rheumatoid Arthritis
Primary outcomes
- Major malformations — 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.
Countries
United States