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NCT03198351 · ClinicalTrials.gov registry record

An Observational Study on Teriflunomide-exposed Pregnancies

A clinical trial of Multiple Sclerosis, sponsored by Sanofi.

Completed
Registry status
220
Enrollment target
2
Study locations

NCT03198351 is a study of Multiple Sclerosis that has completed, run by Sanofi. The registered enrollment target is 220 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03198351, a study of Multiple Sclerosis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
220 participants
Enrollment target
2
Study locations

Study Summary

Primary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. Secondary Objective: To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.

Conditions Studied

Multiple Sclerosis

Interventions

  • DRUG Teriflunomide (HMR1726)

Study Locations (2)

California

  • University of California at San Diego-Site Number:001 - San Diego

Other

  • Investigational Site Number :002 - Canada

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2013-04-25
Est. Completion 2023-06-13

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT03198351

The ClinicalTrials.gov registry entry for NCT03198351 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (62% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Teriflunomide (HMR1726) is the first listed.

NCT03198351 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Other.

Frequently Asked Questions

What is clinical trial NCT03198351 about?

NCT03198351 is a clinical study titled "An Observational Study on Teriflunomide-exposed Pregnancies". Primary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. Secondary Objective: To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pa...

What is the current status of trial NCT03198351?

This trial is currently completed. The enrollment target is 220 participants. The study started on 2013-04-25. Estimated completion is 2023-06-13.

What conditions does trial NCT03198351 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT03198351?

The interventions under investigation include: Teriflunomide (HMR1726) (DRUG).

Who is sponsoring clinical trial NCT03198351?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03198351 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.