Abatacept Pregnancy Exposure Registry

NCT ID: NCT01087125

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant RA patients with abatacept exposure during pregnancy

No Interventions

Intervention Type DRUG

No Interventions

Interventions

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No Interventions

No Interventions

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

The Organization of Teratology Information Specialists

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Bristol-Myers Squibb, Active

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM101-121

Identifier Type: -

Identifier Source: org_study_id

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