Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review
Not Applicable
- Conditions
- euromyelitis optica spectrum disorder
- Registration Number
- JPRN-UMIN000050027
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
Any previous treatment with IL-6 inhibitory therapy except satralizumab.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical measures related to disease activity through 26 weeks and 130 weeks after the start of treatment with satralizumab - Annualized relapse rate - Time to first relapse - Proportion of relapse-free patients 2. Details of relapse - Position of relapse - Chief complaint of relapse - Visual acuity at the time of relapse - Content of acute treatment - Proportion of hospitalization due to relapse - Length of hospital stay at the time of relapse - Proportion of patients who re-started satralizumab after relapse and time to restart - Types and doses of concomitant medications at relapse - Biologics started after relapse under satralizumab treatment 3. Dose of concomitant medication over time for the patient who had relapse during satralizumab treatment
- Secondary Outcome Measures
Name Time Method