Actively Recruiting
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
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive blood test for anti-AChR or anti-MuSK antibodies confirmed at screening
- Diagnosis of Myasthenia Gravis supported by specific tests or clinical signs
- MGFA Clinical Classification Class II, III, or IV at screening and randomization
- MG-ADL score of 5 or greater with more than 50% from non-eye symptoms
- QMG score of 11 or greater at screening and randomization
- Willing and able to complete study assessments and follow-up visits
- Female participants of childbearing potential must use highly effective contraception during the study and for 12 months after the last dose
- Non-sterilized males with female partners of childbearing potential must use condoms during the study and for 3 months after last dose
You will not qualify if you...
- Any condition causing unacceptable risk or interfering with study evaluation
- Pregnant or breastfeeding females or those planning pregnancy during study and 6 months after last dose
- History of drug or alcohol abuse within 1 year prior to screening
- Site staff or family members
- Committed to an institution by official or judicial order
- Diagnosis of congenital myasthenic syndromes
- Known immunodeficiency including HIV infection
- Thymectomy within 12 months before baseline or planned during study
- Prior treatment with certain immunosuppressive or immunotherapy drugs
- Use of intravenous immunoglobulin or plasma exchange within 4 weeks before Day 1
- Current use of prednisone above specified doses or unstable pyridostigmine dosing
- Participation in other investigational studies within 4 weeks or 5 half-lives prior to Day 1
- Receipt of live attenuated vaccines within 4 weeks prior to randomization
- History of severe allergic reactions to biologic agents or study drug components
- Recurrent significant infections or active infection needing treatment within 2 weeks before screening
- Unresected thymoma or certain cancer histories with recent treatment
- Recent pregnancy outcomes within 4 weeks prior to screening
- Specific laboratory abnormalities at screening
- Positive tests for chronic hepatitis B, hepatitis C, or HIV
- Blood transfusion within 4 weeks prior to or during screening
- Inability to read
- History of active or latent tuberculosis unless treated or completing treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive intravenous infusions of either rituximab or placebo administered on Day 1 and Day 15.
2 infusion visits over 2 weeks plus follow-up visits during 12 weeks
Trial Site Locations
Total: 1 location
1
Policlinico A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
Research Team
R
Raffaele Iorio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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