Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abatacept Pregnancy Exposure Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087125
Recruitment Status : Unknown
Verified January 2019 by Bristol-Myers Squibb.
Recruitment status was:  Recruiting
First Posted : March 16, 2010
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
University of California, San Diego
The Organization of Teratology Information Specialists
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date March 12, 2010
First Posted Date March 16, 2010
Last Update Posted Date February 1, 2019
Actual Study Start Date September 30, 2006
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2010)
Major structural birth defects of newborns [ Time Frame: Throughout pregnancy and up to 1 year of life ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 15, 2010)
  • 3 or more minor structural defects [ Time Frame: at dysmorphological exam ]
  • Spontaneous abortion [ Time Frame: throughout pregnancy ]
  • Premature delivery [ Time Frame: throughout pregnancy ]
  • Small for gestational age [ Time Frame: at birth ]
  • Postnatal growth deficiency [ Time Frame: throughout pregnancy and up to 1 year of life ]
  • Postnatal serious infections, hospitalizations or malignancies [ Time Frame: 1st year of life ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Abatacept Pregnancy Exposure Registry
Official Title Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women
Condition Rheumatoid Arthritis
Intervention Drug: No Interventions
No Interventions
Study Groups/Cohorts Pregnant RA patients with abatacept exposure during pregnancy
Intervention: Drug: No Interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 17, 2014)
240
Original Estimated Enrollment
 (submitted: March 15, 2010)
100
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01087125
Other Study ID Numbers IM101-121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study 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
PRS Account Bristol-Myers Squibb
Verification Date January 2019