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Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

NCT05868837 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-01

No results posted yet for this study

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

DRUG

Rituximab

Rituximab 1000 mg IV on RCP days 1 and 15

OTHER

Placebo

Placebo 1000 mg IV on RCP days 1 and 15

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Raffaele Iorio · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868837 on ClinicalTrials.gov