An Observational Study on Teriflunomide-exposed Pregnancies
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 7/12/2018 |
| Start Date: | April 25, 2013 |
| End Date: | February 1, 2022 |
| Contact: | Trial Transparency email recommended (Toll free number for US & Canada) |
| Email: | Contact-US@sanofi.com |
| Phone: | 800-633-1610 |
Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project
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.
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.
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.
- 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.
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.
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