Clinical trial NCT03198351: An Observational Study on Teriflunomide-exposed Pregnancies
Official title: Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 220
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Pregnant women will be enrolled at various stages of gestation depending when they are included in the registry; then the pregnant outcome will be followed and for live infants, the follow up will be up to the children's 1 year birthday.

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.

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.

Primary outcomes:
measure: Rate of major structural defects in live born infants
timeFrame: Up to the infant's first year birthday
Secondary outcomes:
measure: Proportion of major structural defects in all pregnancies
timeFrame: up to 1 year of age in infant
measure: Specific pattern of 3 or more minor structural defects in live born infants receiving the exam
timeFrame: up to one year after birth
measure: Rate of spontaneous abortion
timeFrame: date of conception to 20 weeks gestation
measure: Rate of preterm delivery
timeFrame: live birth prior to 37 weeks gestation
measure: 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
timeFrame: at birth
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego-Site Number:001
state: California
city: Canada
country: Canada
facility: Investigational Site Number :002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: