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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 is a clinical trial that has completed, run by Sanofi. The registered enrollment target is 113 participants.
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.
Interventions
- DRUG Sarilumab SAR153191 (REGN88)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2024-12-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03378219
The ClinicalTrials.gov registry entry for NCT03378219 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sarilumab SAR153191 (REGN88) is the first listed.
NCT03378219 reports 0 study locations.
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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