An Observational Study on Teriflunomide-exposed Pregnancies

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198351
• Other study ID #: OBS13499
• Secondary ID: U1111-1183-8711
• Status: Completed
• Start date: April 25, 2013
• Est. completion date: June 13, 2023

Study information

• Verified date: August 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Teriflunomide (HMR1726)
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
Canada	Investigational Site Number :002	Canada
United States	University of California at San Diego-Site Number:001	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major structural defects in live born infants		Up to the infant's first year birthday
Secondary	Proportion of major structural defects in all pregnancies		up to 1 year of age in infant
Secondary	Specific pattern of 3 or more minor structural defects in live born infants receiving the exam		up to one year after birth
Secondary	Rate of spontaneous abortion		date of conception to 20 weeks gestation
Secondary	Rate of preterm delivery		live birth prior to 37 weeks gestation
Secondary	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		at birth
Secondary	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		1 year