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

Exclusion Criteria

• •1. Patients with a history of severe hypersensitivity or anaphylactic reactions to components of rituximab or products derived from mouse protein
• •2. Patients whose cardiopulmonary function is judged by the treating physician to be not maintained
• •3. Patients complaining of fatigue that does not meet the diagnostic criteria for ME/CFS
• •4. Patients found to have other medical conditions that may cause symptoms
• •5. Patients who are pregnant, lactating, or have a positive pregnancy test (serum human chorionic gonadotropin test) at the time of enrollment
• •6. Patients with coexisting or pre-existing malignant tumors (excluding basal cell carcinoma of the skin and cervical dysplasia)
• •7. Patients with coexisting or pre-existing severe immune system diseases (excluding autoimmune diseases such as thyroiditis and type 1 diabetes)
• •8. 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)
• •9. 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.
• •10. Patients with severe endogenous (primary) depression
• •11. Patients with a neutrophil count \<1.5\*103/microliter and platelet count \<10.0\*104/microliter on blood test
• •12. Patients with impaired renal function (serum creatinine level \> 1.5 times the upper limit of the reference value at the institution)
• •13. 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)
• •14. Patients infected with Human Immunodeficiency Virus (HIV)
• •15. 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.
• •However, patients who meet the following conditions (1) and (2) may be registered.
• •(i) Patients who are positive for HBs or HBc antibodies and whose HBV-DNA quantification is confirmed to be negative (less than detection sensitivity) and for whom appropriate monitoring, etc. can be conducted in accordance with the Guidelines for Hepatitis B Treatment edited by the Japan Society of Hepatology.
• •(ii) For patients with positive HCV antibody, when HCV-RNA quantification is negative (less than detection sensitivity)
• •16. Patients who do not have the ability to comply with the study protocol
• •17. Patients who have participated in other clinical trials or clinical studies (except for observational studies without intervention) within 16 weeks prior to obtaining consent
• •18. Other patients who are judged by the investigator or subinvestigator (hereinafter referred to as investigator) to be inappropriate to participate in this clinical trial.