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Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

Study acronym: REFINE
StatusUnknown
PhasePhase 3
Started
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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv5
  3. Eligibility criteria expanded, about 2 wordsv4
  4. Re-verified, no change to tracked fieldsv3
  5. Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria shortened, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will: * Allow faster and greater corticosteroid tapering * Reduce the frequency of exacerbations * Improve quality of life * Offer an acceptable safety and tolerability profile.
Trial Details
NCT Number NCT05868837
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)		 Myasthenia Gravis, Generalized
Related terms Myasthenia Gravis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov