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Completed

NCT Number: NCT03198351

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 pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Investigational Site Number :002, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teriflunomide (HMR1726)

Drug

Pharmaceutical form: tablet

Route of administration: oral

Other names: Aubagio

Primary outcomes

  1. Rate of major structural defects in live born infants

    Time frame: Up to the infant's first year birthday

Secondary outcomes

  1. Proportion of major structural defects in all pregnancies

    Time frame: up to 1 year of age in infant

  2. Specific pattern of 3 or more minor structural defects in live born infants receiving the exam

    Time frame: up to one year after birth

  3. Rate of spontaneous abortion

    Time frame: date of conception to 20 weeks gestation

  4. Rate of preterm delivery

    Time frame: live birth prior to 37 weeks gestation

  5. Proportion of infants who are small for gestational age (less than or equal to the 10th percentile for gestational age and sex) on weight, length, or head circumference

    Time frame: at birth

  6. Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2017
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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