Relapsing-remitting multiple sclerosis
Conditions
Interventions
Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.
Sponsors
Department of Immunology, National Institute of Neuroscience, NCNP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis as relapsing-remitting multiple sclerosis (RRMS) according to 2010 revised McDonald criteria (Ann Neurol 2011; 69: 292-302). 2. Intractable patients with RRMS resistant to standard therapies other than tocilizumab with more than two relapses or disability progression during the 1 year prior to initiation to this study. 3. With a higher plasmablast frequency in peripheral blood than the mean frequency + 2SD in healthy donors by flow cytometry. 4. Provision of written informed consent to participate in this study. 5. Since a relapsing-remitting phase could turn out to be a secondary-progressive phase after the entry, the patients with secondary-progressive MS (SPMS) could be included in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with severe infection such as tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection, hepatitis B, hepatitis C, or chronic active EB virus infection. 2) Patients with a history of tuberculosis infection or patients with pleural thickness or old tuberculin in chest X-ray. 3) Patients with a history of hypersensitivity to this drug. 4) Patients with a history of intestinal diverticulum. 5) Patients with interstitial pneumonitis. 6) Patients with leukopenia (white blood cell number < 3500/mm3), lymphopenia (lymphocyte number < 500/mm3) or seropositivity for beta-D-glucan in peripheral blood. 7) Pregnant women or patients with possible pregnancy. 8) Patients with a history of allergy to this drug 9) Patients who can not provide consent to participate in this study by themselves.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Relapse rate, disability (EDSS), and MRI parameters up to 1 or 2 years. -Adverse events up to 1 or 2 years. | — |
Countries
Japan
Contacts
Public ContactTakashi Yamamura
National Institute of Neuroscience, NCNP Department of Immunology
Outcome results
None listed