NCT01087125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

13.2 years

First QC Date

March 12, 2010

Last Update Submit

July 18, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Major structural birth defects of newborns

    Throughout pregnancy and up to 1 year of life

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Pregnant RA patients with abatacept exposure during pregnancy

Drug: No Interventions

Interventions

No InterventionsDRUG

No Interventions

Pregnant RA patients with abatacept exposure during pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • 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

You may not qualify if:

  • Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol-Myers Squibb, Active

Princeton, New Jersey, 08540, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 16, 2010

Study Start

September 1, 2006

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

US(1)