Abatacept Pregnancy Exposure Registry
- Registration Number
- NCT01087125
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
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
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Exclusion Criteria
- Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant RA patients with abatacept exposure during pregnancy No Interventions -
- Primary Outcome Measures
Name Time Method Major structural birth defects of newborns Throughout pregnancy and up to 1 year of life
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Bristol-Myers Squibb, Active
🇺🇸Princeton, New Jersey, United States