Abatacept Pregnancy Exposure Registry

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

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: No Interventions

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bristol-Myers Squibb, Active

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant RA patients with abatacept exposure during pregnancy	Drug: No Interventions; No Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major structural birth defects of newborns	Throughout pregnancy and up to 1 year of life

Secondary Outcome Measures

Outcome Measure	Time Frame
3 or more minor structural defects	at dysmorphological exam
Spontaneous abortion	throughout pregnancy
Premature delivery	throughout pregnancy
Small for gestational age	at birth
Postnatal growth deficiency	throughout pregnancy and up to 1 year of life
Postnatal serious infections, hospitalizations or malignancies	1st year of life

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: University of California, San Diego; The Organization of Teratology Information Specialists
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 12, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimated): March 16, 2010

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-121