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NCT03378219 · ClinicalTrials.gov registry record
An Observational Study on Sarilumab-exposed Pregnancies
A clinical trial, sponsored by Sanofi.
- Completed
- Registry status
- 113
- Enrollment target
NCT03378219: Completed study, sponsored by Sanofi.
NCT03378219 is a clinical trial that has completed, run by Sanofi. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03378219 has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- 113 participants
- Enrollment target
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.
Primary Outcome
A major structural birth defect is a defect that has either cosmetic or functional significance to the child (eg, a cleft lip) and is identified up to one year of age by the mother, the health care provider/medical record, or identified in the dysmorphological examination.
Interventions
- DRUG Sarilumab SAR153191 (REGN88)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2024-12-06 |
What the finished NCT03378219 record still lists
NCT03378219 is an observational study that tracks outcomes without assigning an intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Sarilumab SAR153191 (REGN88) is the first listed.
NCT03378219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03378219 about?
NCT03378219 is a clinical study titled "An Observational Study on Sarilumab-exposed Pregnancies". 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 he...
What is the current status of trial NCT03378219?
This trial is currently completed. The enrollment target is 113 participants. The study started on 2018-05-18. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT03378219?
The interventions under investigation include: Sarilumab SAR153191 (REGN88) (DRUG).
Who is sponsoring clinical trial NCT03378219?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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