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An Observational Study on Teriflunomide-exposed Pregnancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	16 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03198351
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sanofi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Sciences & Operations
Principal Investigator Affiliation	Sanofi
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Additional 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.

Arms & Interventions

Arms

: Cohort I

Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy

: Cohort II

Pregnant women with MS not exposed to teriflunomide during the current pregnancy

: Cohort III

Healthy pregnant women who do not have a known diagnosis of MS and have no known exposure to a known human teratogen

: "Registry" group (not eligible for cohorts)

Women who contact the OTIS registry study staff and who do not meet the criteria for the prospective study, for example, at time of contacting the study, having known prenatal diagnosis of congenital defect, or gestation weeks greater than 20 following a first trimester teriflunomide exposure, etc.; these participants will not be included in the primary analysis for the cohort study.

Interventions

Drug: - Teriflunomide (HMR1726)

Pharmaceutical form: tablet Route of administration: oral

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Diego, California

Status

Recruiting

Address

University of California at San Diego-Site Number:001

San Diego, California, 92093

Site Contact

[email protected]

International Sites

Investigational Site Number :002, Canada, Canada

Status

Recruiting

Address

Investigational Site Number :002

Canada, ,

Site Contact

[email protected]

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