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OTIS Humira Pregnancy Registry

NCT01086059 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 944

Last updated 2025-01-28

No results posted yet for this study

Summary

The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Kenneth L Jones, MD · University of California, San Diego

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2016-08-31
Completion
2019-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01086059 on ClinicalTrials.gov