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An Observational Study on Sarilumab-exposed Pregnancies

NCT03378219 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2025-01-17

No results posted yet for this study

Summary

Primary Objective:

To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.

Secondary Objective:

To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.

Conditions

  • Rheumatoid Arthritis -Exposure During Pregnancy

Interventions

DRUG

Sarilumab SAR153191 (REGN88)

Pharmaceutical form:injection Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2024-12-06
Completion
2024-12-06
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT03378219 on ClinicalTrials.gov