Trials / Completed
CompletedNCT03378219
An Observational Study on Sarilumab-exposed Pregnancies
Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 113 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Detailed description
Pregnant women enrolled in the study will participate for the duration of that pregnancy. Those who deliver at least one live born infant and the infants will participate for 1 year after delivery of that infant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sarilumab SAR153191 (REGN88) | Pharmaceutical form:injection Route of administration: subcutaneous |
Timeline
- Start date
- 2018-05-18
- Primary completion
- 2024-12-06
- Completion
- 2024-12-06
- First posted
- 2017-12-19
- Last updated
- 2025-01-17
Locations
2 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03378219. Inclusion in this directory is not an endorsement.