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A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk

Study acronym: PROVIDE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2026 → Oct 31, 2026
See other at-risk trials from TG Therapeutics, Inc.

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 2 of 5 entries · Site details revised at 5 of 5 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 5 of 5 sites
  2. Re-verified, no change to tracked fieldsv32
  3. Primary and study completion pushed from Jun 30, 2026 to Oct 31, 2026v31
  4. 2 versions Re-verified since May 11, 2026, no change to tracked fieldsv29-v30
  5. Study sites: 4 to 5v28
Show 26 earlier versionsHide 26 earlier versions
  1. 2 versions Re-verified since Jan 28, 2026, no change to tracked fieldsv26-v27
  2. Study sites: 3 to 4v25
  3. Study sites: 2 to 3v24
  4. 2 versions Re-verified since Sep 30, 2025, no change to tracked fieldsv22-v23
  5. Study sites: 1 to 2v21
  6. 2 versions Re-verified since Jun 30, 2025, no change to tracked fieldsv19-v20
  7. Primary and study completion dates: Jun 28, 2025 to Jun 30, 2026v18
  8. 12 versions Re-verified since May 13, 2024, no change to tracked fieldsv6-v17
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 15, 2024 to Mar 26, 2024v5 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 15, 2024 to Mar 26, 2024
  10. 3 versions Re-verified since Dec 20, 2023, no change to tracked fieldsv2-v4
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
Trial Details
NCT Number NCT06143514
Lead Sponsor TG Therapeutics, Inc.
Conditions Relapsing Multiple Sclerosis
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov