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A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 8 words
  2. 16 versions Re-verified since Apr 28, 2025, no change to tracked fieldsv5-v20
  3. Primary and study completion dates: Jun 28, 2025 to Mar 31, 2035 Start date: Mar 26, 2024 to Jun 1, 2024v4 Show 1 more changeShow less
    • Start date: Mar 26, 2024 to Jun 1, 2024
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jan 1, 2030 to Jun 28, 2025 · Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2024 to Mar 26, 2024v2 Show 3 more changesShow less
    • Primary and study completion dates: Jan 1, 2030 to Jun 28, 2025
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2024 to Mar 26, 2024
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
Trial Details
NCT Number NCT06433765
Lead Sponsor TG Therapeutics, Inc.
Conditions Multiple Sclerosis
Enrollment 728 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov