Summary

Eligibility
for females ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
estimated completion

Description

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.

Official Title

Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project

Details

The total study duration per participant is approximately up to 2 years. - This is a prospective, observational study (no intervention), ie, patient registry. - The statistical analysis for the cohort study describe baseline characteristics in all three cohorts, and then will compare pregnancy outcomes in cohort 1 to cohort 2 and secondarily to cohort 3. - For the "registry" group, without comparisons, only descriptive statistics of pregnancy outcomes will be summarized.

Keywords

Multiple Sclerosis, Teriflunomide, Teriflunomide (HMR1726)

Eligibility

You can join if…

Open to females ages 16 years and up

:

  • Pregnant women who have provided an oral and/or written consent to enroll no later than 20 completed weeks from last menstrual period (LMP).
  • Pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants (up to 1 year post birth).
  • Pregnant women with a diagnosis of MS and teriflunomide exposure during pregnancy (Cohort 1).
  • Pregnant women with MS but not exposed teriflunomide during pregnancy (Cohort 2).
  • Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen during pregnancy (Cohort 3).

You CAN'T join if...

  • Pregnant women who come in first contact with the project after prenatal diagnosis of a major structural defect (Cohort 1, 2, 3). This does not apply to the "registry" group.
  • Pregnant women who first come in contact with the project after 20 completed weeks' gestation (Cohort 1, 2, 3). This does not apply to the "registry" group.
  • Pregnant women who had previously enrolled in the study for a previous pregnancy (only 1 pregnancy, per woman, maybe registered) (Cohort 1, 2, 3). This does not apply to the "registry" group.
  • Retrospectively reported cases (Cohort 1, 2, 3). This does not apply to the "registry" group.
  • Pregnant women with exposures to teriflunomide commencing after the 12th week post-LMP (Cohort 1). This does not apply to the "registry" group.
  • Pregnant women who had previously been treated with teriflunomide if they had received any dose of the drug within 2 years prior to the index pregnancy and do not have documented blood levels below 0.02 mcg/mL prior to pregnancy (Cohort 2).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations

  • University of California at San Diego-Site Number:001 accepting new patients
    San Diego California 92093 United States
  • Investigational Site Number :002 accepting new patients
    Canada Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT03198351
Study Type
Observational [Patient Registry]
Participants
Expecting 325 study participants
Last Updated