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Report for Clinical Trial NCT02073279

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.

NCT02073279 Neuromyelitis Optica (NMO) NMO Spectrum Disorder (NMOSD)
MeSH:Neuromyelitis Optica

2 Interventions

Name: Satralizumab

Description: Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Type: Drug
Group Labels: 2

Placebo Satralizumab

Name: Placebo

Description: Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Measure: Time to First Protocol-Defined Relapse in the Double-Blind Period

Time: From the date of randomization until the first occurrence of relapse throughout the double-blind period (up to approximately 38 months)

Secondary Outcomes

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 24

Description: 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 24

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 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)

Measure: Percentage of Participants Who Are Relapse-Free Over Time

Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Annualized Relapse Rate

Time: From Baseline 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)

Measure: Change from Baseline Over Time in Visual Acuity (Snellen Chart)

Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Change from Baseline Over Time in Low-Contrast Visual Acuity, as Assessed Using the Low-Contrast Sloan Letter Chart (LCSLC)

Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Number of Participants with at Least One Adverse Event by Severity

Time: From Baseline until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Number of Participants with at Least One Serious Adverse Event by Severity

Time: From Baseline until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Number of Participants with Non-Serious Adverse Events of Special Interest by Severity

Time: From Baseline until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Number of Participants with Selected Adverse Events by Severity

Time: From Baseline until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)

Measure: Number of Participants by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

Time: Baseline, Weeks 2, 4, 8, and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks and every 12 weeks thereafter of open-label extension period (up to approximately 6.75 years)

Measure: Serum Satralizumab Concentration Over Time

Time: Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks and every 24 weeks thereafter of open-label extension period (up to approximately 6.75 years)

Measure: Serum Interleukin-6 (IL-6) Concentration Over Time

Time: Baseline, Weeks 2, 4, 8, and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks of open-label extension period (up to approximately 6.75 years)

Measure: Serum Soluble IL-6 Receptor (sIL-6R) Concentration Over Time

Time: Baseline, Weeks 2, 4, 8, and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks of open-label extension period (up to approximately 6.75 years)

Measure: Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration Over Time

Time: Baseline, Weeks 2, 4, 8, and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks of open-label extension period (up to approximately 6.75 years)

Measure: Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time

Time: Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period; every 24 weeks for first 48 weeks of open-label extension period (up to approximately 6.75 years)

Measure: Blood Plasmablast Concentration Over Time

Time: Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period (up to approximately 38 months)

Measure: Number of Participants with Anti-Drug Antibodies to Satralizumab

Time: Baseline and every 4 weeks thereafter of double-blind period; every 4 weeks for first 48 weeks and every 24 weeks thereafter of open-label extension period (up to approximately 6.75 years)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T25W

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 ---



HPO Nodes