Detailed Description
The efficacy and safety of rituximab (genetical recombination), a CD20 antibody, 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.
Study Start (Actual)
2025-04-09
Primary Completion (Estimated)
2026-09-30
Study Completion (Estimated)
2027-10-31
Enrollment (Estimated)
30
Recruiting at National Center of Neurology and Psychiatry (NCNP)
Drug: Rituximab(Genetical Recombination)
Inclusion Criteria:
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)
Secondary Outcomes
The efficacy and safety of rituximab (genetical recombination), a CD20 antibody, 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.
Study Start (Actual)
2025-04-09
Primary Completion (Estimated)
2026-09-30
Study Completion (Estimated)
2027-10-31
Enrollment (Estimated)
30
Recruiting at National Center of Neurology and Psychiatry (NCNP)
Drug: Rituximab(Genetical Recombination)
- Subjects 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.
Inclusion Criteria:
- 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 whose written consent has been obtained
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)
Secondary Outcomes
- 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 (%)
- Duration of standing and activity (hours)
- Patients will be asked to report the level of fatigue they feel even while lying down, and changes in their fatigue levels will be aggregated.
- Patients will be asked to describe the specific activities they perform and the exhaustion they experience afterward, and a summary table will be created.
- Patients will be asked to report the level of fatigue they experience during physical activity in daily life, and changes in fatigue levels will be aggregated.
- Evaluation based on Fatigue Score
- SF-36
- COMPASS31
- Pittsburgh Sleep Quality Index (PSQI)
- Pain intensity
- Grip strength
- Analysis of the gut microbiota
- Brain imaging evaluation (Magnetic Resonance Imaging (MRI) of the head, Single Photon Emission Computed Tomography (SPECT) of cerebral blood flow)
- Immune biomarker analysis (qPCR)
- Immune biomarker analysis (anti-autonomic receptor antibody analysis)
- Immune biomarker analysis (immune cell subfractionation analysis)
- Metabolome analysis
- Adverse events
- Vital signs (body temperature)
- Vital signs (pulse rate)
- Serum immunoglobulins (IgG)
- Serum immunoglobulins (IgA)
- Serum immunoglobulins (IgM)
- Rituximab concentration of the blood plasma
- Blood drug concentration Anti-Drug Antibody (ADA)
- B cells (CD19/CD20 positive cells) and T cells (CD3/CD4/CD8 positive cells)
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