Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
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Open (Enrolling)
Female
Rheumatoid Arthritis
Female
Rheumatoid Arthritis
Trial Information
Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
Inclusion Criteria:
- Currently pregnant women who agree 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:
- Women who come in first contact with the project after prenatal diagnosis of a fetal
abnormality
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Major structural birth defects of newborns
Outcome Time Frame:
Throughout pregnancy and up to 1 year of life
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Institutional Review Board
Study ID:
IM101-121
NCT ID:
NCT01087125
Start Date:
September 2006
Completion Date:
December 2013
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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