An Observational Study on Sarilumab-exposed Pregnancies
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- STATUS
- Recruiting
-
- End date
- Aug 12, 2027
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- participants needed
- 300
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- sponsor
- Sanofi
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.
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.
Details
| Condition | Rheumatoid Arthritis -Exposure During Pregnancy |
|---|---|
| Age | 100 years and younger |
| Treatment | Sarilumab SAR153191 (REGN88) |
| Clinical Study Identifier | NCT03378219 |
| Sponsor | Sanofi |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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