Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
1 other identifier
observational
867
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2032
May 16, 2024
May 1, 2024
10.5 years
June 18, 2021
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of major structural defects
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (e.g., a cleft lip).
Up to 10,5 years
Secondary Outcomes (10)
Number of spontaneous abortion/miscarriage
Up to 10,5 years
Number of stillbirth
Up to 10,5 years
Number of elective termination
Up to 10,5 years
Number of premature delivery
Up to 10,5 years
Number of preeclampsia / eclampsia
Up to 1 10,5 years
- +5 more secondary outcomes
Study Arms (3)
Siponimod-Exposed
Pregnant women with MS exposed to siponimod during pregnancy
Disease-Matched Comparison
Pregnant women with MS not exposed to siponimod during pregnancy
Healthy Comparison
Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy
Interventions
Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled.
Eligibility Criteria
The study population includes pregnant women who reside in the US or Canada.
You may qualify if:
- 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
- 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 ASQ in live born children
- Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
- Pregnant women
- 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 ASQ in live born children
You may not qualify if:
- 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)
- The teratogenicity of teriflunomide is unknown and currently under investigation
- Other anti-CD20 monoclonal antibody: same class as Kesimpta
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
- Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
La Jolla, California, 92093-0934, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 21, 2021
Study Start
December 15, 2021
Primary Completion (Estimated)
May 31, 2032
Study Completion (Estimated)
May 31, 2032
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share