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Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders

Study acronym: THERAMAG
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2027 Completion date: Dec 2025 to Dec 2028 · Site details revised at 14 of 15 sitesv5 Show 2 more changesShow less
    • Completion date: Dec 2025 to Dec 2028
    • Site details revised at 14 of 15 sites
  2. Study sites: 14 to 15 Eligibility criteria revisedv4 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2023 to Jun 29, 2023 · Site details revised at 14 of 14 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2023 to Jun 29, 2023
    • Site details revised at 14 of 14 sites
  4. Primary completion date: Dec 2024 to Dec 2025 Start date: Jun 2022 to May 2023 · Primary endpoint revised · Secondary endpoints revised (9) · 1 morev2 Show 4 more changesShow less
    • Start date: Jun 2022 to May 2023
    • Primary endpoint revised
    • Secondary endpoints revised (9)
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Anti-MAG neuropathy is a progressively disabling orphan rare disorder due to a monoclonal immunoglobulin M(IgM) gammopathy displaying reactivity toward MAG, a glycoprotein of the peripheral nervous system. Its prevalence is around 1/100000 and to date, no treatment has proven efficacy in this disease, including rituximab in 2 Randomized Controlled Trails(RCTs).
Trial Details
NCT Number NCT05136976
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France
Conditions Anti-MAG Neuropathy
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov