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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087125
Recruitment Status : 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

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: No Interventions

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
Actual Study Start Date : September 30, 2006
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

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




Primary Outcome Measures :
  1. Major structural birth defects of newborns [ Time Frame: Throughout pregnancy and up to 1 year of life ]

Secondary Outcome Measures :
  1. 3 or more minor structural defects [ Time Frame: at dysmorphological exam ]
  2. Spontaneous abortion [ Time Frame: throughout pregnancy ]
  3. Premature delivery [ Time Frame: throughout pregnancy ]
  4. Small for gestational age [ Time Frame: at birth ]
  5. Postnatal growth deficiency [ Time Frame: throughout pregnancy and up to 1 year of life ]
  6. Postnatal serious infections, hospitalizations or malignancies [ Time Frame: 1st year of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087125


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, New Jersey
Bristol-Myers Squibb Recruiting
Princeton, New Jersey, United States, 08540
Contact: Bristol-Myers Squibb, Site 0001    877-311-8972      
Sponsors and Collaborators
Bristol-Myers Squibb
University of California, San Diego
The Organization of Teratology Information Specialists
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01087125     History of Changes
Other Study ID Numbers: IM101-121
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors