NCT01087125CompletedNot Applicable
Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
Bristol-Myers Squibb1 site in 1 country42 target enrollmentStarted: September 1, 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Major structural birth defects of newborns
Study Overview
Brief Summary
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pregnant RA patients with abatacept exposure during pregnancy
Intervention: No Interventions (Drug)
Outcomes
Primary Outcomes
Major structural birth defects of newborns
Time Frame: Throughout pregnancy and up to 1 year of life
Secondary Outcomes
- 3 or more minor structural defects(at dysmorphological exam)
- Small for gestational age(at birth)
- Spontaneous abortion(throughout pregnancy)
- Postnatal serious infections, hospitalizations or malignancies(1st year of life)
- Postnatal growth deficiency(throughout pregnancy and up to 1 year of life)
- Premature delivery(throughout pregnancy)
Investigators
Study Sites (1)
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