Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 867
- Locations
- 1
- Primary Endpoint
- Prevalence of major structural defects
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
Detailed Description
The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used siponimod during pregnancy but have been diagnosed with MS (disease-matched unexposed comparison group), and a comparison group of healthy women who do not have diagnosis of MS, have not had exposure to a known human teratogen, and have not taken siponimod in pregnancy (healthy comparison group). Pregnant women exposed to siponimod who do not meet the prospective cohort criteria will also be followed as part of an exposure series. All participants will be recruited via voluntary participant registration following informed consent by the pregnant woman for her participation. Participants may withdraw from the study at any time.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
- •Cohort 1: Siponimod-Exposed Cohort
- •Pregnant women
- •Diagnosed with MS, with the indication validated by medical records when possible
- •Exposure to siponimod for the treatment of MS, for any number of days, at any dose, and at any time from the 4th day post the first day of LMP prior to conception up to and including the end of pregnancy
- •Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and the Ages and Stages Questionnaire (ASQ) in live born children
- •Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- •Pregnant women
- •Diagnosed with MS, with the indication validated by medical records when possible
- •May or may not have taken another medication for MS in the current pregnancy
Exclusion Criteria
- •Women meeting any of the following criteria will be excluded from the cohort study:
- •Cohort 1: Siponimod-Exposed Cohort
- •Women who have enrolled in the siponimod cohort study with a previous pregnancy
- •Women who have used siponimod for an indication other than a currently approved indication
- •Women with exposure to any of the following medications within 5 half-lives prior to conception:
- •Cladribine (Mavenclad)
- •Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
- •All other S1P modulators including fingolimod (Gilenya), ozanimod, etc.
- •S1P modulatros are in the same class of drug as siponimod
- •Teriflunomide (Aubagio)
Outcomes
Primary Outcomes
Prevalence of major structural defects
Time Frame: Up to 10,5 years
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (e.g., a cleft lip).
Secondary Outcomes
- Number of premature delivery(Up to 10,5 years)
- Number of elective termination(Up to 10,5 years)
- Small for gestational age(Up to 10,5 years)
- Postnatal growth small for age at approximately one year of age(Up to 10,5 years)
- Developmental performance at approximately one year of age(Up to 10,5 years)
- Number of stillbirth(Up to 10,5 years)
- Serious or opportunistic infections in the first year of life(Up to 10,5 years)
- Pattern of 3 or more minor structural defects(Up to 10,5 years)
- Number of spontaneous abortion/miscarriage(Up to 10,5 years)
- Number of preeclampsia / eclampsia(Up to 1 10,5 years)