Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGNo Interventions
No Interventions
Sponsors
University of California, San Diego
The Organization of Teratology Information Specialists
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major structural birth defects of newborns | Throughout pregnancy and up to 1 year of life |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous abortion | throughout pregnancy |
| Premature delivery | throughout pregnancy |
| 3 or more minor structural defects | at dysmorphological exam |
| Postnatal growth deficiency | throughout pregnancy and up to 1 year of life |
| Postnatal serious infections, hospitalizations or malignancies | 1st year of life |
| Small for gestational age | at birth |
Countries
United States
Outcome results
None listed