Actively Recruiting
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-01
40
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive test for anti-AChR or anti-MuSK antibodies confirmed at screening
- History of abnormal neuromuscular tests or improvement with cholinesterase inhibitors, or clinical diagnosis consistent with MG
- MGFA Clinical Classification Class II, III, or IV at screening and randomization
- MG-ADL score of 5 or greater at screening and randomization with more than half of score from non-eye symptoms
- QMG score of 11 or greater at screening and randomization
- Willing and able to comply with study protocol and attend follow-up visits
- Females of childbearing potential must use effective contraception from screening to 12 months after last dose
- Non-sterilized males with partners of childbearing potential must use condoms during study and for 3 months after last dose
You will not qualify if you...
- Any condition posing unacceptable risk or interfering with study or safety evaluation
- Pregnant, lactating, or planning pregnancy during study plus 6 months after last dose
- History of drug or alcohol abuse within 1 year prior to screening
- Site staff and their family members
- Institutionalized by official or judicial order
- Diagnosed with congenital myasthenic syndromes
- Known immunodeficiency including HIV infection
- Thymectomy within 12 months before baseline or planned during study
- Prior treatment with specific immunosuppressive or immune-modulating therapies
- Use of intravenous immunoglobulin or plasma exchange within 4 weeks prior to Day 1
- Current use of prednisone under 20 mg/day or unstable pyridostigmine dose
- Enrollment in other investigational studies within 4 weeks or 5 half-lives before Day 1
- Receipt of live vaccines within 4 weeks prior to randomization
- History of severe allergic reactions to biologics or components of study drug
- History of recurrent serious infections
- Active infections requiring antimicrobials within 2 weeks before screening
- Unresected thymoma or malignant thymoma not meeting specific criteria
- History of certain cancers except specific treated types without recurrence
- Recent pregnancy outcomes within 4 weeks prior to screening
- Abnormal liver, kidney, blood counts, or immunoglobulin levels 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 or positive test for active or latent tuberculosis unless treated or in treatment with intent to complete
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Policlinico A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
Research Team
R
Raffaele Iorio
CONTACT
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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