Neuromyelitis optica
Conditions
Interventions
Rituximab intravenous infusion
Sponsors
Clinical Research Center, Utano National Hospital, National Hospital Organization
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants in the RIN-1 study who meet all of the following criteria can be included. 1) Patients who have completed the RIN-1 study and have been stable for at least 4 weeks if having relapses in the RIN-1 study. 2) Women of childbearing ages who are negative for a pregnancy test on Visit 1 and consent avoidance of the pregnancy during the trial. 3) Patients who give written informed consent. Patients under 20 years of age are require parental consent. 4) Patients who are able to follow the study protocol and schedule and who can report their symptoms.
Exclusion criteria
Exclusion criteria: 1) Patients who have completed RIN-1 study 6 months ago or earlier. 2) Patients who required to continue acute-phase treatments such as methylprednisolone pulse therapy or plasma exchange. 3) Patients treated with oral corticosteroid more than 30 mg per day (in prednisolone conversion). 4) Patients with hypersensitivity to mouse protein derivatives or those with a history of anaphylactic reaction to components of rituximab. 5) Patients infected with HBV, HCV, or HIV, those with an active infectious diseases, or those with a history of severe chronic or recurrent infections. 6) Patients who received a monoclonal antibody (e.g., natalizumab or rituximab, except for rituximab use according to the protocol in the RIN-1 study), cladribine, radiation treatment (whole-body irradiation or lymphoid irradiation), stem-cell transplant, mitoxantrone, cyclophosphamide infusion, immunoglobulin therapy, immunomodulatory drugs (interferon beta, glatiramer acetate), oral immunosuppressive agents other than steroids (e.g., azathioprine, tacrolimus, cyclosporine, cyclophosphamide, methotrexate, or fingolimod), or live vaccines within 6 months before Visit 1. 7) Patients with autoimmune diseases, such as Sjogren's syndrome or systemic lupus erythematosus, requiring treatment with immunosuppressants. 8) Patients who are pregnant or feeding a baby. 9) Patients who are participating in other clinical trials for NMO. 10) Patients diagnosed as having a cancer. 11) Patients who are considered unfit for the enrollment in the trial after an investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Expanded Disability Status Scale (EDSS) and Quantification of Optic nerve and Spinal cord Impairment (QOSI) from the baseline score, and the proportion of steroid-free patients | — |
Countries
Japan
Contacts
Public ContactMasayuki Tahara
Utano National Hospital Clinical Research Center
Outcome results
None listed