Actively Recruiting
Phase 3 Study of Rituximab for Treating Generalized Myasthenia Gravis with Positive AChR Antibodies
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Rituximab in people with generalized Myasthenia Gravis who test positive for specific antibodies. This phase III trial aims to see if Rituximab can reduce the physical disability caused by this condition. The study also looks at whether the treatment can help patients reduce their use of corticosteroids faster, decrease the number of disease flare-ups, improve quality of life, and maintain an acceptable safety profile. Participants will receive either Rituximab or a placebo through intravenous infusions. Rituximab is given as two 1000 mg doses spaced two weeks apart. The placebo consists of saline solution given in the same way. The study compares these two groups to assess the effects of Rituximab over time. During the study, participants will be regularly assessed over 12 weeks to measure changes in their functional abilities related to Myasthenia Gravis. Secondary assessments will track corticosteroid use and overall disability over 48 weeks. Researchers will monitor safety, treatment adherence, and quality of life through various exams and questionnaires. The total duration of participation includes initial screening and follow-up visits to observe treatment effects and any side effects.
CONDITIONS
Brief Title
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
Research Team
R
Raffaele Iorio
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