🏛️ Verified NIH Record • Updated 2024-05-14

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (NCT04933552)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (32 items).

Location: Novartis Investigative Site — La Jolla, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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)
  • The teratogenicity of teriflunomide is unknown and currently under investigation
  • Other anti-CD20 monoclonal antibody: same class as Kesimpta
  • New medications (marketed after 2020) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Novartis Investigative Site — La Jolla, California

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗