An Observational Study on Teriflunomide-exposed Pregnancies

NCT ID: NCT03198351

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-25
• Study Completion Date: 2023-06-13

Brief 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.

Detailed Description

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort I

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

Teriflunomide (HMR1726)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Cohort II

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

No interventions assigned to this group

Cohort III

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

No interventions assigned to this group

"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.

No interventions assigned to this group

Interventions

Teriflunomide (HMR1726)

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Aubagio

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

University of California at San Diego-Site Number:001

San Diego, California, United States

Investigational Site Number :002

Canada, , Canada

Countries

United States; Canada

Other Identifiers

U1111-1183-8711

Identifier Type: OTHER

Identifier Source: secondary_id

OBS13499

Identifier Type: -

Identifier Source: org_study_id