NCT05868837

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 1000 mg IV on RCP days 1 and 15
OTHER	Placebo	Placebo 1000 mg IV on RCP days 1 and 15

Timeline

• Start date: 2022-02-28
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-05-22
• Last updated: 2025-08-01

Locations

1 site across 1 country: Italy