Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study

Bristol-Myers Squibb1 site in 1 country42 target enrollmentSeptember 1, 2006

ConditionsRheumatoid Arthritis

InterventionsNo Interventions

DrugsNo Interventions

Overview

Phase: Not Applicable
Intervention: No Interventions
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Enrollment: 42
Locations: 1
Primary Endpoint: Major structural birth defects of newborns
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2006

End Date

December 31, 2019

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

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)