The efficacy and safety of rituximab on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.
Patients diagnosed with ME/CFS who meet the Canadian criteria by a physician.
Patients with a severity score of 4 or higher on the Performance Status (PS) based ME/CFS severity classification by the Ministry of Health, Labour and Welfare Research Group
Patients who are between 18 and 65 years of age at the time of obtaining written consent
Patients who can be hospitalized (hospitalized from the day before administration and discharged the day after administration) at the time of the first dose of each of the primary and secondary evaluation periods
Patients with a history of severe hypersensitivity or anaphylactic reactions to components of rituximab or products derived from mouse protein
Patients whose cardiopulmonary function is judged by the treating physician to be not maintained
Patients complaining of fatigue that does not meet the diagnostic criteria for ME/CFS
Patients found to have other medical conditions that may cause symptoms
Crossover
Rituximab(Genetical Recombination)
DrugSubjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.
Placebo
DrugSubjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.
Improvement rate
Percentage of cases in which the severity score of ME/CFS based on PS by the MHLW research group improved by 1 or more compared to that before the start of study drug administration (week 0)
Percentage of patients whose MHLW-PS-based ME/CFS severity score improved by 1 or more at each evaluation point (improvement rate) compared to that before the start of treatment with the investigational drug (week 0).
The amount of change in the severity score of ME/CFS based on PS by the MHLW Research Group at each assessment point from that before the start of treatment with the investigational drug (week 0)
Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)
Changes in proportions will be aggregated.
Duration of standing and activity (hours)
Changes in time will be aggregated.
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