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Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

Study acronym: KATHAROS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 15 sitesv16
  2. Primary completion moved earlier from May 18, 2026 to Feb 20, 2026v15
  3. 2 versions Re-verified since Apr 28, 2026, no change to tracked fieldsv13-v14
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 20 to confirmed 24 · Study sites: 22 to 15 · Completion date: Feb 23, 2027 to Oct 29, 2026v12 Show 3 more changesShow less
    • Enrollment target: estimated 20 to confirmed 24
    • Study sites: 22 to 15
    • Completion date: Feb 23, 2027 to Oct 29, 2026
  5. Site details revised at 3 of 22 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 5 of 22 sitesv10
  2. Site details revised at 11 of 22 sitesv9
  3. Study sites: 17 to 22v8
  4. Study sites: 11 to 17v7
  5. Study sites: 12 to 11v6
  6. Study sites: 9 to 12v5
  7. Primary completion date: Aug 22, 2025 to May 18, 2026 Study sites: 8 to 9 · Completion date: Feb 2, 2026 to Feb 23, 2027v4 Show 2 more changesShow less
    • Study sites: 8 to 9
    • Completion date: Feb 2, 2026 to Feb 23, 2027
  8. Study sites: 3 to 8 Primary completion date: Oct 24, 2025 to Aug 22, 2025 · Start date changed from estimate of Aug 30, 2024 to Nov 25, 2024v3 Show 2 more changesShow less
    • Primary completion date: Oct 24, 2025 to Aug 22, 2025
    • Start date changed from estimate of Aug 30, 2024 to Nov 25, 2024
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 31, 2024 to Aug 30, 2024 · Study sites: 0 to 3 · Primary completion date: Jun 16, 2025 to Oct 24, 2025 · 1 morev2 Show 4 more changesShow less
    • Start date: Jul 31, 2024 to Aug 30, 2024
    • Study sites: 0 to 3
    • Primary completion date: Jun 16, 2025 to Oct 24, 2025
    • Completion date: Jun 15, 2026 to Feb 2, 2026
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
See 31 trials at risk
Multiple Sclerosis
991 trials monitored
See 36 trials at risk
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
Trial Details
NCT Number NCT06444113
Lead Sponsor Novartis Pharmaceuticals
Conditions Multiple Sclerosis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov