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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

NCT00658827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 370

Last updated 2025-02-03

No results posted yet for this study

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-biologic exposed patients; and information pertaining to health status, during the first year following delivery, of infants born to women following prenatal exposure to infliximab and their unexposed counterparts.

Conditions

Interventions

OTHER

No intervention

This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed.

Sponsors & Collaborators

Principal Investigators

  • Janssen Biotech, Inc. Clinical Trial · Janssen Biotech, Inc.

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2016-09-30
Completion
2016-09-30

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658827 on ClinicalTrials.gov