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OTIS Vedolizumab Pregnancy Exposure Registry

NCT02678052 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 303

Last updated 2024-10-08

No results posted yet for this study

Summary

The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents.

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab exposure

BIOLOGICAL

Other Biological Agent

Other Biological Agent exposure

Sponsors & Collaborators

  • The Organization of Teratology Information Specialists

    collaborator OTHER

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

  • Study Director · The Organization of Teratology Information Specialists

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2022-07-15
Completion
2022-07-31

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 NCT02678052 on ClinicalTrials.gov