The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
Name: Satralizumab
Description: Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).Type: DrugSatralizumab Placebo
Name: Placebo
Description: Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).Type: DrugPlacebo
Description: The VAS for pain is a subjective measure and it consists of a 100 millimeter (mm) line with two end points representing 'no pain' to 'pain as bad as it could be'. Participants are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.
Measure: Change from Baseline to Week 24 in the Visual Analogue Scale (VAS) Score for Pain Time: Baseline, Week 24Description: FACIT fatigue scale includes 13 statements, which measures fatigue/asthenia for participants with chronic, life-threatening illnesses. For each question, a participant rates his/her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). A score is calculated by averaging the individual question scores, with lower scores indicative of less fatigue.
Measure: Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Time: Baseline, Week 24Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the Short Form Generic Health Survey (SF-36) Bodily Pain Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 General Health Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Mental Health Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Physical Functioning Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Role-Emotional Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Role-Physical Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Social Role Functioning Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Vitality Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Mental Component Summary Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Physical Component Summary Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state.
Measure: Change from Baseline Over Time in the EuroQoL-5 Dimensions (EQ-5D) Index Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The T25W is the measurement to assess walking ability. The time (in seconds) that it takes the participant to walk 25 feet is measured.
Measure: Change from Baseline Over Time in the Timed 25-Foot Walk (T25W) Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The mRS is a 7-point disability scale that assesses the degree of disability in patients with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability.
Measure: Change from Baseline Over Time in Modified Rankin Scale (mRS) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden.
Measure: Change from Baseline Over Time in Zarit Burden Interview (ZBI) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measure: Change from Baseline Over Time in Expanded Disability Status Scale (EDSS) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Allocation: Randomized
Parallel Assignment
There is one SNP
A higher score reflects a better health state.. Change from Baseline Over Time in the Timed 25-Foot Walk (T25W). --- T25W ---
The T25W is the measurement to assess walking ability. --- T25W ---