Abatacept Pregnancy Exposure Registry

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: No Interventions

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01087125

IM101-121

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

42 participants in 1 patient group

Pregnant RA patients with abatacept exposure during pregnancy

Treatment:

Drug: No Interventions