Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT05868837
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 1000 mg IV on RCP days 1 and 15
  • Placebo — OTHER
    Placebo 1000 mg IV on RCP days 1 and 15

Study Details

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.

Key Dates

Start date
Feb 28, 2022
Status verified
Sep 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab will be provided in 500mg/50ml vials; excipients include sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections. Two vials will be diluted in 500 ml of sodium chloride 0,9% to reach a concentration of 2mg/ml. Rituximab will be administered intravenously in two 1000 mg infusions, with two weeks distance between the first and the second infusion.
  • Placebo Comparator: Placebo
    Placebo will consist of 500 ml flacons of sodium chloride 0,9%.

Primary Outcome Measure

To assess whether rituximab can reduce MG-related functional impairment. [ Time Frame: 12 weeks ]

Central Contacts

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