An Observational Study on Teriflunomide-exposed Pregnancies

Investigating Pregnancy Outcomes with Teriflunomide Exposure

Not Recruiting
16 years or above
Female
Phase N/A
220 participants needed

Study Overview

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.

Study 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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Sclerosis
  • Age: 16 years or above
  • Gender: Female

Inclusion criteria :

  • 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).

Exclusion criteria:

  • 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.

Updated on 28 Aug 2023. Study ID: NCT03198351

This study investigates the potential risks associated with teriflunomide exposure during pregnancy. Teriflunomide is a medication used to treat multiple sclerosis (MS). The study aims to understand if there is an increased risk of major birth defects in babies during their first year of life when their mothers were exposed to teriflunomide while pregnant. Additionally, the study looks at other possible pregnancy outcomes such as minor birth defects, miscarriage, stillbirth, early delivery, and the size of the baby at birth and at one year.

Participants in this study will be part of a prospective, observational study, which means the researchers will observe and collect data without providing any treatment to the participants. Pregnant women will be grouped into three cohorts based on teriflunomide exposure and MS diagnosis. The study will involve interviews, medical record reviews, and physical examinations of the infants up to one year after birth.

  • Who can participate: Pregnant women can participate if they consent before 20 weeks of pregnancy, agree to study conditions, and have a diagnosis of MS with or without teriflunomide exposure, or be healthy without MS or teratogen exposure.
  • Study details: Participants will be observed in a registry without receiving any study-related treatments. The study requires interviews, medical record access, and infant examinations to compare outcomes between different groups of pregnant women.
  • Study Timelines: The study will last approximately 2 years.