Status:
COMPLETED
Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis
Lead Sponsor:
Janssen Biotech, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Inflammatory Bowel Disease
Eligibility:
FEMALE
Brief Summary
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non...
Detailed Description
This registry will analyze birth outcomes data from Medical Birth Registers on approximately 370 women who have become pregnant and have been exposed to infliximab with the diseases of interest: Infla...
Eligibility Criteria
Inclusion
- Study patients must meet the following criteria: Women of childbearing age with birth outcomes recorded in either the Swedish Medical Birth Register (SMBR), Finnish Medical Birth Register (FMBR) or in the Danish Medical Birth Register (DMBR) who have confirmed diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or psoriasis and documented exposure to infliximab during pregnancy and infants born to these women
- Control patients must meet the following criteria: Women of childbearing age with birth outcomes recorded in either the SMBR, FMBR or DMBR who have confirmed diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or psoriasis, and no exposure to biologics during pregnancy and infants born to these women
Exclusion
- Information for women who do not have a documented history of the diseases of interest but whose birth outcomes are included in the SMBR, FMBR or DMBR during the study period and the infants of these women
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00658827
Start Date
January 1 2007
End Date
September 30 2016
Last Update
February 3 2025
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