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OpenTrials
Completed

NCT Number: NCT01087125

Abatacept Pregnancy Exposure Registry

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Bristol-Myers Squibb, Active

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Interventions

Drug

No Interventions

Primary outcomes

  1. Major structural birth defects of newborns

    Time frame: Throughout pregnancy and up to 1 year of life

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • The Organization of Teratology Information Specialists
  • University of California, San Diego

Registry information

Official study title

Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2010
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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