An Observational Study on Teriflunomide-exposed Pregnancies
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|ClinicalTrials.gov Identifier: NCT03198351|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : July 10, 2018
To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
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.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Teriflunomide (HMR1726)|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||325 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project|
|Actual Study Start Date :||April 25, 2013|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Pregnant women with a confirmed diagnosis of multiple sclerosis (MS) and teriflunomide exposure during the current pregnancy
Drug: Teriflunomide (HMR1726)
Pharmaceutical form: tablet
Route of administration: oral
Other Name: Aubagio
Pregnant women with MS not exposed to teriflunomide during the current pregnancy
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.
- Rate of major structural defects in live born infants [ Time Frame: Up to the infant's first year birthday ]
- Proportion of major structural defects in all pregnancies [ Time Frame: up to 1 year of age in infant ]
- Specific pattern of 3 or more minor structural defects in live born infants receiving the exam [ Time Frame: up to one year after birth ]
- Rate of spontaneous abortion [ Time Frame: date of conception to 20 weeks gestation ]
- Rate of preterm delivery [ Time Frame: live birth prior to 37 weeks gestation ]
- 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 [ Time Frame: at birth ]
- 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 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198351
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext 1 then #||Contact-US@sanofi.com|
|United States, California|
|San Diego, California, United States, 92093|
|Study Director:||Clinical Sciences & Operations||Sanofi|