Abatacept Pregnancy Exposure Registry

Bristol-Myers Squibb42 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

No InterventionsDRUG

No Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Bristol-Myers Squibb, Active

Princeton, New Jersey, United States

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

Time frame: at dysmorphological exam

Spontaneous abortion

Time frame: throughout pregnancy

Premature delivery

Time frame: throughout pregnancy

Small for gestational age

Time frame: at birth

Postnatal growth deficiency

Time frame: throughout pregnancy and up to 1 year of life

Postnatal serious infections, hospitalizations or malignancies

Time frame: 1st year of life

Data from ClinicalTrials.gov

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