Abatacept Pregnancy Exposure Registry | NCT01087125

Studies
Abatacept Pregnancy Exposure Registry

NCT01087125

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jul 20, 2023Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

No Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2006Actual

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 12, 2010

First Submission Date that Met QC Criteria

Mar 15, 2010

First Posted Date

Mar 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 20, 2023Actual

Name	Class
University of California, San Diego	OTHER
The Organization of Teratology Information Specialists	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant RA patients with abatacept exposure during pregnancy			Drug: No Interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Interventions	Drug	No Interventions	Pregnant RA patients with abatacept exposure during pregnancy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
3 or more minor structural defects		at dysmorphological exam
Spontaneous abortion		throughout pregnancy
Premature delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol-Myers Squibb, Active		Princeton	New Jersey	08540	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases