Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

NCT06952413 | Recruiting Phase 2

• 1 other identifier: IDEC-C2B8-MC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Outcome Measures

Primary Outcomes (1)

• 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)

  From Baseline to the end of treatment at 24 weeks

Secondary Outcomes (29)

• 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).

  At 4-week intervals from Baseline up to Week 48

• 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)

  At 4-week intervals from Baseline up to Week 48

• Proportion of awake time spent in supine position (%),Proportion of awake time spent in sitting position (%)

  At 4-week intervals from Baseline up to Week 48

• Duration of standing and activity (hours)

  At 4-week intervals from Baseline up to Week 48

• Fatigue during rest and lying position

  At 4-week intervals from Baseline up to Week 48

Study Arms (2)

Rituximab(Genetical Recombination)

ACTIVE COMPARATOR

Drug: Rituximab(Genetical Recombination)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rituximab(Genetical Recombination) DRUG

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.

Rituximab(Genetical Recombination)

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who are pregnant, lactating, or have a positive pregnancy test (serum human chorionic gonadotropin test) at the time of enrollment
• Patients with coexisting or pre-existing malignant tumors (excluding basal cell carcinoma of the skin and cervical dysplasia)
• Patients with coexisting or pre-existing severe immune system diseases (excluding autoimmune diseases such as thyroiditis and type 1 diabetes)
• Patients with a history of systemic immunosuppressive therapy (e.g., immunoglobulin therapy, azathioprine, cyclosporine, mycophenolate mofetil, etc.) within 1 year, a history of receiving drugs such as monoclonal antibodies acting on the immune system (e.g., anti-CD20 antibody products including rituximab), or a history of comorbidities requiring treatment with immunosuppressive drugs Patients with comorbidities requiring treatment with immunosuppressive agents (excluding treatment with low-dose steroids of 5 mg /day or less)
• Patients who have started alternative medicine (reference: acupuncture, moxibustion, and Japanese warm therapy) within 12 weeks prior to the start of treatment with the investigational drug.
• Patients with severe endogenous (primary) depression
• Patients with a neutrophil count \<1.5\*103/microliter and platelet count \<10.0\*104/microliter on blood test
• Patients with impaired renal function (serum creatinine level \> 1.5 times the upper limit of the reference value at the institution)
• Patients with impaired hepatic function (serum bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) levels exceeding 1.5 times the upper limit of the reference value of the institution)
• Patients infected with Human Immunodeficiency Virus (HIV)
• Patients who test positive for at least one of Hepatitis B surface (HBs) antigen, HBs antibody, Hepatitis B core (HBc) antibody, or Hepatitis C virus (HCV) antibody.

Sponsors & Collaborators

• National Center of Neurology and Psychiatry, Japan: lead

Study Sites (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomoko Okamoto, MD

  National Center of Neurology and Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takami Ishizuka, PhD

CONTACT

+081-42-341-2711; tmc-crso@ncnp.go.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 30, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)