Actively Recruiting
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
Led by Novartis Pharmaceuticals · Updated on 2024-05-16
867
Participants Needed
1
Research Sites
545 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Diagnosed with multiple sclerosis, confirmed by medical records when possible (for siponimod-exposed and disease-matched cohorts)
- Exposure to siponimod for MS treatment from 4 days after last menstrual period before conception through end of pregnancy (siponimod-exposed cohort)
- Willingness to participate in interviews, release medical records, allow infant examinations, and complete developmental questionnaires
- Pregnant women without MS willing to participate under the same study conditions (healthy comparison cohort)
You will not qualify if you...
- Prior enrollment in the siponimod cohort with a previous pregnancy (siponimod-exposed cohort)
- Use of siponimod for unapproved indications
- Exposure to cladribine, S1P modulators (e.g., fingolimod, ozanimod), teriflunomide, or anti-CD20 monoclonal antibodies within 5 half-lives before conception
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic test result for major structural defects before enrollment
- Diagnosis of MS or autoimmune disease in healthy comparison cohort
- Exposure to known human teratogens during pregnancy
- Enrollment in siponimod or Kesimpta cohorts with previous pregnancy
- Treatment with Mayzent or Kesimpta for non-MS indications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Novartis Investigative Site
La Jolla, California, United States, 92093-0934
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
D
Diana Johnson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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