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Tests treatment safety and results for Myalgia Encephalomyelitis/Chronic Fatigue Syndrome...
Official title Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
ClinicalTrials.gov ID: NCT06952413
What this study is testing
What is Rituximab(Genetical Recombination)?
Rituximab(Genetical Recombination) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for myalgia encephalomyelitis/chronic fatigue syndrome (me/cfs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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...
- Patients whose written consent has been obtained
You likely can't join 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)
See the full eligibility 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
- 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...
- 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. However, patients who meet the following conditions...
- Patients who do not have the ability to comply with the study protocol
- Patients who have participated in other clinical trials or clinical studies (except for observational studies without intervention) within 16 weeks prior to obtaining consent
- Other patients who are judged by the investigator or subinvestigator (hereinafter referred to as investigator) to be inappropriate to participate in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Kodaira, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kodaira, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.