neuromyelitis optica
Conditions
Interventions
Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.
Sponsors
Department of Immunology, National Institute of Neuroscience, NCNP
Department of Neurology, Kinki University Faculty of Mediceine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of neuromyelitis optica (NMO), as defined by 2006 criteria published in NEUROLOGY vol. 66 or NMO seropositive spectrum disorder (recurrent optic neuritis or longitudinally extensive transverse myelitis). All patients must be anti-aquaporin 4 antibody seropositive. Patients with intractable NMO who are resistant to the standard therapy or experiencing sever adverse reactions of the current therapy. History of at least one relapse during the 1 year prior to initiation of this study. Provision of written informed consent to participate 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 < 4000/mm3), lymphopenia (lymphocyte number < 1000/mm3) or seropositivity for beta-D-glucan in peripheral blood. 7) Pregnant women or patients with possible pregnancy. 8) Patients who can not provide consent to participate in this study by themselves. 9) Patients whose EDSS are more than 7.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse events up to 2 years -MRI lesion parameters, relapsing rate, and EDSS up to 2 years | — |
Countries
Japan
Contacts
Public ContactTakashi Yamamura
National Institute of Neuroscience, NCNP Department of Immunology
Outcome results
None listed