Prospective Pregnancy Exposure Registry of Women and Infants Exposed to PONVORY™ (ponesimod) During Pregnancy

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Information About this Study

This is a longitudinal, prospective pregnancy exposure registry cohort study that will be conducted in the US. The study is designed to compare obstetrical, maternal, fetal and infant outcomes of women with MS exposed to PONVORY within 7 days prior to conception or during pregnancy.

The study will recruit prospectively female patients with pregnancies exposed to PONVORY starting at the time of US launch (19 March 2021). The study will collect data for approximately 10 years.

Who Can Participate

- Cohort A: Patients with MS exposed to at least one dose of PONVORY at any time within 7 days prior to conception or during pregnancy.
- Cohort B: Patients with MS who have not been exposed to PONVORY or another S1P receptor modulator in the 3 months prior to conception or during pregnancy
- Cohort C: Females in the general population without MS who have never been exposed to PONVORY or another S1P receptor modulator
All Three Cohorts
1. Be able and willing to provide written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent/legal guardian).
2. Be able and willing to provide a signed Release of Medical Information form for mother and infant records.
- History of liver or renal insufficiency (estimated creatinine clearance below [60] mL/min); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- Known allergies, hypersensitivity, or intolerance to study intervention or its excipients.
- Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within [XX] days/months before the planned first dose of study intervention or is currently enrolled in an investigational study