Abatacept Pregnancy Exposure Registry

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087125
• Other study ID #: IM101-121
• Status: Completed
• Start date: September 1, 2006
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• No Interventions
No Interventions

Locations

Country	Name	City	State
United States	Bristol-Myers Squibb, Active	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	The Organization of Teratology Information Specialists, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major structural birth defects of newborns		Throughout pregnancy and up to 1 year of life
Secondary	3 or more minor structural defects		at dysmorphological exam
Secondary	Spontaneous abortion		throughout pregnancy
Secondary	Premature delivery		throughout pregnancy
Secondary	Small for gestational age		at birth
Secondary	Postnatal growth deficiency		throughout pregnancy and up to 1 year of life
Secondary	Postnatal serious infections, hospitalizations or malignancies		1st year of life

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls