An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica
- Conditions
- euromyelitis optica
- Registration Number
- JPRN-UMIN000017217
- Lead Sponsor
- Clinical Research Center, Utano National Hospital, National Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method 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