RecruitingPhase 3NCT05868837

Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

Single-cell Deep Phenotyping of B Lymphocytes to Personalize Immunotherapy in Patients With Myasthenia Gravis: Clinical Trial to Evaluate the Efficacy and Safety of Rituximab in Generalized AChR-antibody Positive Myasthenia Gravis


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

40 participants

Start Date

Feb 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called Rituximab for people with myasthenia gravis, generalized. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

Rituximab 1000 mg IV on RCP days 1 and 15

OTHERPlacebo

Placebo 1000 mg IV on RCP days 1 and 15


Locations(1)

Policlinico A. Gemelli IRCCS

Roma, Italy

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NCT05868837


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