Neuromyelitis optica
Conditions
Interventions
Rituximab intravenous infusion
Placebo
Sponsors
Clinical Research Center, NHO Utano National Hospital
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are seropositive for anti-aquaporin 4 antibody (including those who have previously been seropositive). 2) Patients with a history of either optic neuritis or myelitis. 3) Patients under treatment with oral steroids of dosage of more than 5 mg (within 10% change for at least 3 months before registration). 4) EDSS between 0 and 7.0. 5) Patients who are neurologically stable. 6) Age between 16 and 80 years. 7) Either male or female. Either in-patients or outpatients. 8) Including women of childbearing ages who are negative for a pregnancy test on Visit 1 and consent avoidance of the pregnancy during the trial. 9) Patients who give written informed consent. Patients under 20 years of age are required parental consent. 10) Patients who are able to follow the study protocol and schedule and who can report their symptoms.
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity to mouse protein derivatives or those with a history of anaphylactic reaction to components of rituximab. 2) Patients infected with HBV, HCV, or HIV, and those having active infectious diseases. 3) Patients with severe chronic infection or a history of recurrent infections. 4) Patients who have used a live vaccine within 6 months. 5) Patients under treatment with oral corticosteroid drugs of dosage of higher than 30 mg per day in prednisolone conversion. 6) Patients with previous use of cladribine or a monoclonal antibody, such as natalizumab or rituximab. 7) Patients with a history of radiation treatment (whole body irradiation or lymphoid irradiation) or a stem cell transplant. 8) Patients under treatment with mitoxantrone or cyclophosphamide within 12 months. 9) Patients under treatment with immunomodulatory drugs (interferon beta, glatiramer acetate) or immunoglobulin therapy within 6 months. 10) Patients under treatment with oral immunosuppressive agents other than steroids (e.g., azathioprine, tacrolimus, cyclosporine, cyclophosphamide, methotrexate, or fingolimod) within 3 months. 11) Patients who have received plasma exchange or intravenous steroid pulse therapy within 3 months. 12) Patients with autoimmune diseases, such as Sjogren's syndrome or systemic lupus erythematosus, requiring treatment with immunosuppressants. 13) Patients who are pregnant or feeding a baby. 14) Patients who are participating in other clinical trials for NMO. 15) Patients diagnosed as having a cancer. 16) Patients who are considered unfit for the enrollment in the trial after an investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first relapse from the allocation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Expanded Disability Status Scale (EDSS) and Quantification of Optic nerve and Spinal cord Impairment (QOSI) from the baseline condition, and reduction rate of steroid | — |
Countries
Japan
Contacts
Public ContactMasayuki Tahara
NHO Utano National Hospital Clinical Research Center
Outcome results
None listed