Last reviewed · How we verify
An Observational Study on Teriflunomide-exposed Pregnancies
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Status | COMPLETED |
| Enrolment | 220 |
| Start date | Thu Apr 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Multiple Sclerosis
Interventions
- Teriflunomide (HMR1726)
Countries
Canada, United States