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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: Completed study of Multiple Sclerosis, sponsored by Sanofi.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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
Sanofi

713 total trials

What the finished NCT03198351 record still lists

NCT03198351 is an observational study that tracks outcomes without assigning an intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (62% lower).

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 a single indexed study location in 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.

Similar trials for Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03198351's enrollment target sits among peer trials

220 74th of 315 higher than 242 of 315 other Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03198351, the US trial registry maintained by the National Library of Medicine. NCT03198351 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.