OncoMatch/Clinical Trials/NCT05868837
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
Is NCT05868837 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Rituximab for myasthenia gravis, generalized.
Treatment: Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CHRNA1 anti-AChR antibody positive
Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening
Required: MUSK anti-MuSK antibody positive
Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening
Prior therapy
Cannot have received: alemtuzumab (alemtuzumab)
Alemtuzumab (Lemtrada®, Campath®)
Cannot have received: total lymphoid irradiation
Total lymphoid irradiation
Cannot have received: bone marrow transplant
Bone marrow transplant
Cannot have received: T-cell vaccination therapy
T-cell vaccination therapy
Cannot have received: natalizumab (natalizumab)
Natalizumab (Tysabri®)
Cannot have received: immunosuppressive treatment (excluding corticosteroids) (azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, tocilizumab, belimumab, eculizumab, rituximab, ocrelizumab, ofatumumab, obinutuzumab, inebilizumab)
Exception: excluding corticosteroids
ANY immunosuppressive treatment (excluding corticosteroids) at ANY time prior to randomization (such as Azathioprine, Mycophenolate mofetil or Mycophenolic acid, Cyclosporine (except eye drop), Tacrolimus (except topical), Methotrexate, Cyclophosphamide, Tocilizumab (Actemra®), Belimumab (Benlysta®), Eculizumab (Soliris®), rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent)
Cannot have received: intravenous immunoglobulin
Intravenous immunoglobulin (IVIg) within the 4 weeks prior to Day 1
Cannot have received: plasma exchange
Plasma exchange (PLEX) treatment within the 4 weeks prior to Day 1
Cannot have received: prednisone < 20 mg/day or < 40 mg over a 2-day period (or equivalent dose of other corticosteroids) (prednisone)
Prednisone < 20 mg/day or < 40 mg over a 2-day period (or equivalent dose of other corticosteroids)
Cannot have received: pyridostigmine > 480 mg/day or unstable dose (pyridostigmine)
Pyridostigmine > 480 mg/day or unstable dose in the 2 weeks prior to Day 1
Cannot have received: live attenuated vaccine
Receipt of a live attenuated vaccine within 4 weeks prior to randomization
Cannot have received: blood transfusion
Blood transfusion within 4 weeks prior to screening or during the screening period
Lab requirements
Blood counts
CD19+ B-cell count < 40 cells/μL; ANC < 1.2 × 10^3 cells/μl; platelet count < 75,000/μL; hemoglobin < 8.0 g/dL; total immunoglobulin < 600 mg/dL
Kidney function
eGFR < 45 mL/min/1.73 m2
Liver function
AST or ALT > 2.5 × ULN; total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome)
Any of the following laboratory abnormalities at screening: AST or ALT > 2.5 × ULN; total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome); eGFR < 45 mL/min/1.73 m2; CD19+ B-cell count < 40 cells/μL; ANC < 1.2 × 10^3 cells/μl; platelet count < 75,000/μL; hemoglobin < 8.0 g/dL; total immunoglobulin < 600 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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