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Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

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ClinicalTrials.gov Identifier: NCT02073279
Recruitment Status : Active, not recruiting
First Posted : February 27, 2014
Results First Posted : December 31, 2020
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Neuromyelitis Optica (NMO)
NMO Spectrum Disorder (NMOSD)
Interventions Drug: Satralizumab
Drug: Placebo
Enrollment 95
Recruitment Details The Double-blind (DB) period lasted up to the clinical cut-off date (CCOD: 12 Oct 2018) when the study reached 1.5 years since the date of randomization of the last participant enrolled. The study is ongoing in the open-label extension (OLE) period.
Pre-assignment Details Participants with neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD) were randomized 2:1 to receive either satralizumab 120 mg or matching placebo.
Arm/Group Title Placebo, Then Satralizumab Satralizumab, Then Satralizumab
Hide Arm/Group Description Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Period Title: Double-blind Period
Started 32 63
Completed [1] 17 16
Not Completed 15 47
Reason Not Completed
Adverse Event             1             1
Protocol Deviation             0             1
Withdrawal by Subject             2             2
Reason Not Specified             1             2
Refused Treatment/Did Not Cooperate             0             1
On-going in Study             11             40
[1]
Double-blind Period
Period Title: Open-label Extension Period
Started 17 16
Completed 0 0
Not Completed 17 16
Reason Not Completed
Lack of Efficacy             1             0
Refused Treatment/Did Not Cooperate             0             1
Withdrawal by Subject             1             1
Reason Not Specified             1             1
On-going in Study             14             13
Arm/Group Title Placebo Satralizumab Total
Hide Arm/Group Description Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. Total of all reporting groups
Overall Number of Baseline Participants 32 63 95
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants randomized to the treatment groups.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 63 participants 95 participants
40.5  (10.5) 45.3  (12.0) 43.7  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 63 participants 95 participants
Female
31
  96.9%
46
  73.0%
77
  81.1%
Male
1
   3.1%
17
  27.0%
18
  18.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 63 participants 95 participants
Hispanic or Latino
3
   9.4%
9
  14.3%
12
  12.6%
Not Hispanic or Latino
28
  87.5%
50
  79.4%
78
  82.1%
Not Stated
0
   0.0%
4
   6.3%
4
   4.2%
Unknown
1
   3.1%
0
   0.0%
1
   1.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 63 participants 95 participants
American Indian or Alaska Native
0
   0.0%
2
   3.2%
2
   2.1%
Asian
6
  18.8%
8
  12.7%
14
  14.7%
Black or African American
3
   9.4%
13
  20.6%
16
  16.8%
White
22
  68.8%
37
  58.7%
59
  62.1%
Other
1
   3.1%
3
   4.8%
4
   4.2%
1.Primary Outcome
Title Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period
Hide Description TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse.
Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. For participants who had not relapsed, the TFR was censored on the date of end of the DB period.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Median (95% Confidence Interval)
Unit of Measure: weeks
128.3 [1] 
(29.9 to NA)
NA [2] 
(135.7 to NA)
[1]
Upper limit of CI was not reached due to low number of participants with events.
[2]
Median was not reached due to low number of participants with events. Upper limit of CI was not reached due to low number of participants with events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Satralizumab
Comments Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.23 to 0.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain
Hide Description The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = "no pain" and 100 = "pain as bad as it could be". Participants rated 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 was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data were imputed by BOCF method.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Error)
Unit of Measure: score on scale
Baseline 27.563  (5.438) 31.661  (3.665)
Change from Baseline to Week 24 -5.949  (4.832) -2.735  (4.260)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Satralizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4436
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.215
Confidence Interval 95%
-5.086 to 11.515
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.178
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Hide Description The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data was imputed using BOCF method
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Error)
Unit of Measure: score on scale
Baseline 29.656  (2.280) 30.590  (1.492)
Change from Baseline to Week 24 3.602  (1.820) 5.709  (1.610)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Satralizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1824
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.107
Confidence Interval 95%
-1.008 to 5.221
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.567
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relapse-Free Rate During the DB Period
Hide Description Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse.
Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 23 56
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 23 participants 56 participants
74.87 88.89
Week 24 Number Analyzed 23 participants 56 participants
71.61 85.71
Week 36 Number Analyzed 23 participants 56 participants
61.85 79.37
Week 48 Number Analyzed 23 participants 56 participants
61.85 76.13
Week 72 Number Analyzed 23 participants 56 participants
51.21 74.40
Week 96 Number Analyzed 23 participants 56 participants
51.21 72.14
Week 120 Number Analyzed 23 participants 56 participants
51.21 72.14
Week 144 Number Analyzed 23 participants 56 participants
34.14 62.80
Week 168 Number Analyzed 23 participants 56 participants
34.14 62.80
Week 192 Number Analyzed 23 participants 56 participants
34.14 62.80
Week 216 Number Analyzed 23 participants 0 participants
34.14
5.Secondary Outcome
Title Annualized Relapse Rate (ARR) During the DB Period
Hide Description The ARR is calculated as the total number of participants with adjudicated PDRs experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse.
Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: patients w PDRs/patient-years at risk
0.41
(0.24 to 0.67)
0.17
(0.10 to 0.26)
6.Secondary Outcome
Title Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
42.86  (11.28) 43.20  (11.08)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
-0.89  (8.35) -0.13  (8.09)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
1.75  (5.42) 1.36  (8.89)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
3.19  (8.04) 0.91  (9.23)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
3.43  (5.60) 2.38  (7.82)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
0.00  (8.07) 0.53  (6.21)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-2.22  (8.84) 2.59  (6.66)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
0.80 [1]   (NA) 4.19  (7.01)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-8.47 [2]   (NA) 0  (0)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-12.50 [2]   (NA)
[1]
Standard Deviation (SD) was not calculable for 1 participant.
[2]
SD was not calculable for 1 participant.
7.Secondary Outcome
Title Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
39.43  (9.50) 39.72  (10.41)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
-0.52  (9.96) 0.49  (6.46)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
1.85  (9.72) 1.01  (7.61)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
4.83  (12.41) 3.21  (6.57)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
6.60  (9.10) 3.45  (6.42)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
8.72  (13.55) 3.60  (7.02)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
5.23  (14.11) 2.82  (8.00)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-7.13 [1]   (NA) 5.04  (9.45)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-4.75 [1]   (NA) 8.32  (11.77)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-4.75 [1]   (NA)
[1]
SD was not calculable for 1 participant.
8.Secondary Outcome
Title Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
42.86  (12.69) 46.78  (10.10)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
0.79  (9.02) 1.84  (7.05)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
-0.58  (7.32) 2.67  (7.89)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
2.62  (6.32) 1.95  (7.85)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
-3.60  (6.08) 2.36  (7.38)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-2.62  (6.92) 0.82  (10.32)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
1.31  (1.85) 2.83  (9.43)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
5.23 [1]   (NA) 2.62  (8.89)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-13.08 [1]   (NA) -3.93  (12.95)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-2.62 [1]   (NA)
[1]
SD was not calculable for 1 participant.
9.Secondary Outcome
Title Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
38.70  (12.24) 39.48  (10.99)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
2.20  (4.62) 1.96  (6.12)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
2.34  (6.90) 3.33  (6.76)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
6.62  (9.71) 2.99  (6.94)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
5.50  (9.62) 3.59  (7.49)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
7.01  (8.63) 1.94  (8.05)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
4.79  (9.48) 3.19  (10.87)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
1.91 [1]   (NA) -0.96  (8.62)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-1.92 [1]   (NA) 4.78  (4.06)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-3.83 [1]   (NA)
[1]
SD was not calculable for 1 participant.
10.Secondary Outcome
Title Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
42.24  (13.09) 42.07  (13.62)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
-1.57  (15.67) 3.87  (11.27)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
0.78  (8.57) 2.73  (10.30)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
4.55  (7.96) 3.89  (9.22)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
3.05  (11.98) 1.12  (11.87)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-12.77  (14.07) 1.31  (14.04)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-12.19  (17.23) 1.74  (13.40)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
0.00 [1]   (NA) -0.35  (11.89)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-13.93 [1]   (NA) -3.49  (4.93)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-10.45 [1]   (NA)
[1]
SD was not calculable for 1 participant.
11.Secondary Outcome
Title Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
37.86  (11.28) 37.43  (11.55)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
3.14  (9.92) 3.52  (8.38)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
4.12  (7.24) 5.01  (8.25)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
5.70  (7.65) 4.59  (8.56)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
5.62  (6.35) 4.83  (8.31)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
2.25  (8.99) 3.18  (9.46)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-3.37  (11.12) 2.43  (8.80)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
0.00 [1]   (NA) 0.00  (9.10)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-6.74 [1]   (NA) 4.49  (6.35)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-17.97 [1]   (NA)
[1]
SD was not calculable for 1 participant.
12.Secondary Outcome
Title Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
42.93  (13.22) 41.01  (11.66)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
1.76  (12.42) 2.42  (9.63)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
0.56  (10.59) 2.62  (8.17)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
0.39  (11.66) 3.96  (7.93)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
0.63  (1.77) 3.56  (7.89)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-5.01  (13.26) 0.31  (8.48)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
7.52  (10.63) 3.76  (14.68)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-5.01 [1]   (NA) -1.50  (7.86)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-5.01 [1]   (NA) -2.51  (3.54)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
[1]
SD was not calculable for 1 participant.
13.Secondary Outcome
Title Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
40.72  (11.86) 46.02  (10.58)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
1.49  (10.22) 2.33  (8.29)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
4.79  (9.07) 4.15  (7.49)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
3.43  (9.38) 3.68  (6.43)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
0.00  (7.94) 4.34  (9.39)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-1.98  (11.24) 3.96  (9.94)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-9.41  (7.70) 4.95  (7.95)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-5.94 [1]   (NA) 5.05  (6.58)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-11.88 [1]   (NA) 0.00  (8.40)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-11.88 [1]   (NA)
[1]
SD was not calculable for 1 participant.
14.Secondary Outcome
Title Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
44.03  (13.93) 46.43  (11.55)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
-0.28  (11.19) 2.89  (8.96)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
0.09  (8.96) 2.63  (8.04)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
1.54  (8.18) 3.17  (7.70)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
-2.65  (6.05) 1.91  (9.32)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-10.65  (11.99) 1.03  (12.92)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-5.40  (8.41) 2.98  (12.99)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-0.61 [1]   (NA) 1.63  (11.86)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-14.38 [1]   (NA) -5.88  (7.54)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-4.22 [1]   (NA)
[1]
SD was not calculable for 1 participant.
15.Secondary Outcome
Title Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Hide Description The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
38.89  (11.20) 38.59  (9.68)
Change from Baseline at Week 24 Number Analyzed 20 participants 54 participants
1.78  (4.99) 1.05  (6.14)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
3.57  (4.94) 2.85  (4.90)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
5.68  (7.32) 2.87  (6.80)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
7.25  (7.08) 4.20  (5.90)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
8.95  (8.51) 2.68  (8.72)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
3.18  (10.67) 2.89  (7.11)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-2.00 [1]   (NA) 1.83  (10.96)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-1.79 [1]   (NA) 7.24  (3.35)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-10.84 [1]   (NA)
[1]
SD was not calculable for 1 participant.
16.Secondary Outcome
Title Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Hide 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 scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 62 participants
0.7153  (0.2253) 0.6881  (0.2040)
Change from Baseline at Week 24 Number Analyzed 20 participants 53 participants
0.0031  (0.1602) 0.0188  (0.1812)
Change from Baseline at Week 48 Number Analyzed 18 participants 45 participants
0.0016  (0.1176) 0.0244  (0.1571)
Change from Baseline at Week 72 Number Analyzed 12 participants 42 participants
0.0582  (0.1498) 0.0238  (0.1323)
Change from Baseline at Week 96 Number Analyzed 8 participants 30 participants
0.0447  (0.1508) 0.0460  (0.1067)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-0.0288  (0.1908) 0.0099  (0.1636)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
-0.1001  (0.1416) 0.0063  (0.2299)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
0.0000 [1]   (NA) -0.0261  (0.2532)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-0.2002 [1]   (NA) 0.0299  (0.0423)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-0.2002 [1]   (NA)
[1]
SD was not calculable for 1 participant.
17.Secondary Outcome
Title Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Hide Description The T25W is an assessment of walking ability. The time (in seconds) that the participant took to walk 25 feet was measured. Speed is calculated as 1/Timed 25-Foot Walk where time is measured in seconds. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 29 63
Mean (Standard Deviation)
Unit of Measure: 1/seconds
Baseline Number Analyzed 29 participants 63 participants
0.1442  (0.0793) 0.1355  (0.0561)
Change from Baseline at Week 24 Number Analyzed 19 participants 53 participants
0.0030  (0.0374) 0.0040  (0.0225)
Change from Baseline at Week 48 Number Analyzed 16 participants 45 participants
0.0142  (0.0493) 0.0115  (0.0306)
Change from Baseline at Week 72 Number Analyzed 11 participants 43 participants
0.0205  (0.0531) 0.0071  (0.0257)
Change from Baseline at Week 96 Number Analyzed 6 participants 31 participants
-0.0031  (0.0251) 0.0081  (0.0253)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
0.0489  (0.0301) 0.0063  (0.0386)
Change from Baseline at Week 144 Number Analyzed 2 participants 12 participants
0.0388  (0.0572) 0.0003  (0.0443)
Change from Baseline at Week 168 Number Analyzed 1 participants 9 participants
-0.0656 [1]   (NA) -0.0155  (0.0379)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-0.0812 [1]   (NA) -0.0304  (0.0360)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-0.0917 [1]   (NA)
[1]
SD was not calculable for 1 participant.
18.Secondary Outcome
Title Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Hide Description The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 63 participants
1.66  (1.00) 1.97  (0.98)
Change from Baseline at Week 24 Number Analyzed 19 participants 54 participants
-0.05  (0.40) -0.04  (0.64)
Change from Baseline at Week 48 Number Analyzed 17 participants 46 participants
0.00  (0.94) -0.13  (0.78)
Change from Baseline at Week 72 Number Analyzed 13 participants 43 participants
-0.08  (1.04) -0.12  (0.63)
Change from Baseline at Week 96 Number Analyzed 8 participants 31 participants
-0.38  (0.74) -0.42  (0.99)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-1.00  (0.00) -0.13  (0.81)
Change from Baseline at Week 144 Number Analyzed 2 participants 11 participants
-1.00  (1.41) -0.09  (0.54)
Change from Baseline at Week 168 Number Analyzed 0 participants 10 participants
0.00  (0.67)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
-1.00 [1]   (NA) -0.50  (2.12)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-1.00 [1]   (NA)
[1]
SD was not calculable for 1 participant.
19.Secondary Outcome
Title Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Hide 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. A negative change from baseline indicates an improvement.
Time Frame Baseline up to Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 7 participants 8 participants
19.43  (12.19) 11.32  (7.20)
Change from Baseline at Week 24 Number Analyzed 6 participants 4 participants
0.00  (6.20) 1.50  (9.68)
Change from Baseline at Week 48 Number Analyzed 6 participants 2 participants
-2.83  (6.11) -3.00  (9.90)
Change from Baseline at Week 72 Number Analyzed 3 participants 1 participants
-5.00  (3.00) -13.00 [1]   (NA)
Change from Baseline at Week 96 Number Analyzed 2 participants 0 participants
-1.00  (7.07)
Change from Baseline at Week 120 Number Analyzed 1 participants 0 participants
4.00 [1]   (NA)
[1]
SD was not calculable for 1 participant.
20.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Hide Description The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 32 participants 63 participants
3.66  (1.61) 3.92  (1.50)
Change from Baseline at Week 24 Number Analyzed 20 participants 53 participants
-0.03  (0.38) -0.24  (0.71)
Change from Baseline at Week 48 Number Analyzed 18 participants 46 participants
-0.06  (0.42) -0.32  (0.65)
Change from Baseline at Week 72 Number Analyzed 12 participants 42 participants
0.21  (0.58) -0.29  (0.76)
Change from Baseline at Week 96 Number Analyzed 8 participants 29 participants
-0.50  (0.76) -0.03  (0.48)
Change from Baseline at Week 120 Number Analyzed 3 participants 16 participants
-0.50  (0.87) -0.22  (0.91)
Change from Baseline at Week 144 Number Analyzed 2 participants 11 participants
-1.00  (0.71) 0.18  (0.68)
Change from Baseline at Week 168 Number Analyzed 1 participants 10 participants
-0.50 [1]   (NA) -0.15  (1.13)
Change from Baseline at Week 192 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) 0.25  (1.06)
Change from Baseline at Week 216 Number Analyzed 1 participants 0 participants
-0.50 [1]   (NA)
[1]
SD was not calculable for 1 participant.
21.Secondary Outcome
Title Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Hide Description Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Mean (Standard Deviation)
Unit of Measure: LogMAR units
Baseline: OD Number Analyzed 32 participants 63 participants
0.560  (0.903) 0.449  (0.712)
Baseline: OS Number Analyzed 32 participants 63 participants
0.456  (0.811) 0.545  (0.836)
Change from Baseline at Week 24: OD Number Analyzed 20 participants 53 participants
-0.058  (0.512) 0.039  (0.434)
Change from Baseline at Week 24: OS Number Analyzed 20 participants 53 participants
0.046  (0.242) -0.001  (0.500)
Change from Baseline at Week 48: OD Number Analyzed 18 participants 46 participants
-0.027  (0.097) 0.053  (0.434)
Change from Baseline at Week 48: OS Number Analyzed 18 participants 46 participants
0.050  (0.252) -0.006  (0.591)
Change from Baseline at Week 72: OD Number Analyzed 12 participants 42 participants
-0.050  (0.140) -0.056  (0.260)
Change from Baseline at Week 72: OS Number Analyzed 12 participants 42 participants
-0.083  (0.595) -0.101  (0.492)
Change from Baseline at Week 96: OD Number Analyzed 8 participants 29 participants
-0.045  (0.099) -0.081  (0.580)
Change from Baseline at Week 96: OS Number Analyzed 8 participants 29 participants
-0.260  (0.707) -0.121  (0.571)
Change from Baseline at Week 120: OD Number Analyzed 3 participants 16 participants
-0.027  (0.142) -0.039  (0.637)
Change from Baseline at Week 120: OS Number Analyzed 3 participants 15 participants
0.000  (0.000) -0.229  (0.754)
Change from Baseline at Week 144: OD Number Analyzed 2 participants 11 participants
0.010  (0.127) 0.149  (0.618)
Change from Baseline at Week 144: OS Number Analyzed 2 participants 11 participants
0.000  (0.000) -0.280  (0.846)
Change from Baseline at Week 168: OD Number Analyzed 1 participants 10 participants
-0.080 [1]   (NA) 0.134  (0.663)
Change from Baseline at Week 168: OS Number Analyzed 1 participants 10 participants
-0.100 [1]   (NA) -0.320  (0.910)
Change from Baseline at Week 192: OD Number Analyzed 1 participants 2 participants
-0.180 [1]   (NA) -0.110  (0.156)
Change from Baseline at Week 192: OS Number Analyzed 1 participants 2 participants
0.080 [1]   (NA) -0.050  (0.071)
Change from Baseline at Week 216: OD Number Analyzed 1 participants 0 participants
-0.180 [1]   (NA)
Change from Baseline at Week 216: OS Number Analyzed 1 participants 0 participants
-0.100 [1]   (NA)
[1]
SD was not calculable for 1 participant.
22.Secondary Outcome
Title Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Hide Description The LCSLC evaluates the visual function and captures the minimum size at which individuals can perceive letters of a particular contrast level. The change in binocular visual acuity, as assessed by the number of letters read correctly from a distance of 2 meters on 100%, 2.5% and 1.25% contrast level Sloan letter charts, was analyzed. The LCSLC is scored on a scale of 0-60. Higher scores indicate better visual function. A positive change from baseline indicates an improvement.
Time Frame Baseline up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 29 60
Mean (Standard Deviation)
Unit of Measure: letters
Baseline: 100% CHART Number Analyzed 29 participants 60 participants
44.3  (16.1) 44.4  (16.3)
Baseline: 2.5% CHART Number Analyzed 29 participants 60 participants
24.6  (16.2) 22.6  (15.6)
Baseline: 1.25% CHART Number Analyzed 29 participants 60 participants
17.5  (15.7) 14.9  (14.8)
Change from Baseline at Week 24: 100% CHART Number Analyzed 19 participants 49 participants
0.5  (7.1) 2.0  (5.3)
Change from Baseline at Week 24: 2.5% CHART Number Analyzed 19 participants 49 participants
-2.8  (9.1) 1.7  (7.1)
Change from Baseline at Week 24: 1.25% CHART Number Analyzed 19 participants 49 participants
-4.2  (11.9) 0.1  (7.5)
Change from Baseline at Week 48: 100% CHART Number Analyzed 16 participants 43 participants
-3.4  (8.7) 1.3  (6.1)
Change from Baseline at Week 48: 2.5% CHART Number Analyzed 15 participants 43 participants
1.5  (6.1) 4.0  (9.2)
Change from Baseline at Week 48: 1.25% CHART Number Analyzed 15 participants 43 participants
1.7  (11.3) 4.1  (9.3)
Change from Baseline at Week 72: 100% CHART Number Analyzed 11 participants 41 participants
0.3  (5.9) 2.8  (7.3)
Change from Baseline at Week 72: 2.5% CHART Number Analyzed 11 participants 41 participants
-0.6  (8.6) 2.6  (7.5)
Change from Baseline at Week 72: 1.25% CHART Number Analyzed 11 participants 41 participants
-2.4  (8.3) 0.4  (10.6)
Change from Baseline at Week 96: 100% CHART Number Analyzed 7 participants 28 participants
3.3  (13.2) 2.1  (12.4)
Change from Baseline at Week 96: 2.5% CHART Number Analyzed 7 participants 28 participants
2.6  (20.1) 2.3  (10.8)
Change from Baseline at Week 96: 1.25% CHART Number Analyzed 7 participants 28 participants
-3.4  (11.3) -0.5  (11.3)
Change from Baseline at Week 120: 100% CHART Number Analyzed 3 participants 14 participants
-1.0  (1.0) 1.5  (10.6)
Change from Baseline at Week 120: 2.5% CHART Number Analyzed 3 participants 14 participants
3.7  (4.6) 2.1  (7.3)
Change from Baseline at Week 120: 1.25% CHART Number Analyzed 3 participants 14 participants
-2.0  (5.0) 1.6  (9.1)
Change from Baseline at Week 144: 100% CHART Number Analyzed 2 participants 10 participants
-3.5  (2.1) 0.4  (7.7)
Change from Baseline at Week 144: 2.5% CHART Number Analyzed 2 participants 10 participants
17.5  (17.7) 1.6  (12.0)
Change from Baseline at Week 144: 1.25% CHART Number Analyzed 2 participants 10 participants
-7.0  (7.1) 1.4  (12.2)
Change from Baseline at Week 168: 100% CHART Number Analyzed 0 participants 10 participants
2.1  (6.7)
Change from Baseline at Week 168: 2.5% CHART Number Analyzed 0 participants 10 participants
6.2  (8.2)
Change from Baseline at Week 168: 1.25% CHART Number Analyzed 0 participants 10 participants
0.3  (12.2)
Change from Baseline at Week 192: 100% CHART Number Analyzed 1 participants 2 participants
1.0 [1]   (NA) -2.5  (3.5)
Change from Baseline at Week 192: 2.5% CHART Number Analyzed 1 participants 2 participants
-1.0 [1]   (NA) -1.0  (4.2)
Change from Baseline at Week 192: 1.25% CHART Number Analyzed 1 participants 2 participants
-8.0 [1]   (NA) -4.0  (7.1)
Change from Baseline at Week 216: 100% CHART Number Analyzed 1 participants 0 participants
0.0 [1]   (NA)
Change from Baseline at Week 216: 2.5% CHART Number Analyzed 1 participants 0 participants
-1.0 [1]   (NA)
Change from Baseline at Week 216: 1.25% CHART Number Analyzed 1 participants 0 participants
-8.0 [1]   (NA)
[1]
SD was not calculable for 1 participant.
23.Secondary Outcome
Title Number of Participants With at Least One Adverse Event in the DB Period
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Population (SAF) included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Unit of Measure: participants
24 58
24.Secondary Outcome
Title Number of Participants With at Least One Serious Adverse Event in the DB Period
Hide Description A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Unit of Measure: participants
5 12
25.Secondary Outcome
Title Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period
Hide Description

Non-serious adverse events of special interest for this study included:

1) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment.

Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Unit of Measure: participants
0 0
26.Secondary Outcome
Title Number of Participants With Selected Adverse Events in the DB Period
Hide Description

Selected adverse events for this study included:

1) all infections, 2) serious infections, 3) potential opportunistic infections, 4) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), 5) psychiatric disorders and 6) anaphylaxis (an acute allergic/hypersensitivity reaction).

Time Frame Up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Unit of Measure: participants
All Infections 14 34
Serious Infections 3 6
Potential Opportunistic Infections 5 3
Injection-related Reactions 5 8
Psychiatric Disorders 4 13
Anaphylaxis 0 0
27.Secondary Outcome
Title Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
Hide Description The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior.
Time Frame Baseline and Post-Baseline (up to Week 216)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Measure Type: Number
Unit of Measure: participants
Baseline 0 9
Post-Baseline 1 3
28.Secondary Outcome
Title Serum Satralizumab Concentration During the DB Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from SAF who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Satralizumab
Hide Arm/Group Description:
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 62 participants
145.13  (274.87)
Week 2 Number Analyzed 61 participants
8099.70  (4541.66)
Week 4 Number Analyzed 56 participants
14602.50  (8931.85)
Week 5 Number Analyzed 44 participants
22564.32  (12306.09)
Week 6 Number Analyzed 42 participants
20991.43  (12515.82)
Week 8 Number Analyzed 60 participants
14864.35  (9955.41)
Week 12 Number Analyzed 55 participants
14760.33  (10695.11)
Week 16 Number Analyzed 53 participants
14613.11  (11276.95)
Week 20 Number Analyzed 55 participants
14136.62  (12489.83)
Week 24 Number Analyzed 55 participants
15634.18  (13310.22)
Week 28 Number Analyzed 53 participants
15538.38  (13406.73)
Week 32 Number Analyzed 52 participants
15111.94  (13827.06)
Week 36 Number Analyzed 50 participants
16068.58  (14643.61)
Week 40 Number Analyzed 46 participants
15428.04  (16059.35)
Week 44 Number Analyzed 46 participants
16110.00  (15363.29)
Week 48 Number Analyzed 44 participants
16701.16  (16790.77)
Week 52 Number Analyzed 44 participants
15300.57  (14701.05)
Week 56 Number Analyzed 45 participants
16390.82  (16130.69)
Week 60 Number Analyzed 43 participants
16050.81  (14779.35)
Week 64 Number Analyzed 42 participants
14385.10  (14084.24)
Week 68 Number Analyzed 41 participants
14010.46  (13614.03)
Week 72 Number Analyzed 42 participants
12895.69  (13849.12)
Week 76 Number Analyzed 42 participants
14139.31  (14549.71)
Week 80 Number Analyzed 42 participants
12709.79  (14098.26)
Week 84 Number Analyzed 40 participants
11725.05  (13654.04)
Week 88 Number Analyzed 35 participants
13733.17  (13438.07)
Week 92 Number Analyzed 32 participants
12928.13  (13302.53)
Week 96 Number Analyzed 31 participants
14036.58  (12644.16)
Week 100 Number Analyzed 20 participants
14186.50  (12888.23)
Week 104 Number Analyzed 22 participants
16647.00  (15568.61)
Week 108 Number Analyzed 22 participants
15970.00  (13525.53)
Week 112 Number Analyzed 19 participants
18657.37  (17426.82)
Week 116 Number Analyzed 15 participants
17677.33  (16892.59)
Week 120 Number Analyzed 14 participants
16615.00  (16751.13)
Week 124 Number Analyzed 15 participants
13734.00  (12687.75)
Week 128 Number Analyzed 15 participants
13738.00  (16005.33)
Week 132 Number Analyzed 15 participants
13311.73  (15401.04)
Week 136 Number Analyzed 13 participants
14208.54  (15266.48)
Week 140 Number Analyzed 13 participants
13404.62  (12392.48)
Week 144 Number Analyzed 11 participants
16138.18  (13782.26)
Week 148 Number Analyzed 12 participants
14044.33  (12082.37)
Week 152 Number Analyzed 12 participants
14644.42  (13123.67)
Week 156 Number Analyzed 11 participants
18856.36  (20378.31)
Week 160 Number Analyzed 11 participants
15238.18  (11360.62)
Week 164 Number Analyzed 11 participants
14760.00  (11479.99)
Week 168 Number Analyzed 10 participants
14199.60  (9911.22)
Week 172 Number Analyzed 7 participants
17971.43  (16962.78)
Week 176 Number Analyzed 7 participants
17922.86  (12815.57)
Week 180 Number Analyzed 7 participants
15981.43  (9640.78)
Week 184 Number Analyzed 6 participants
17911.67  (15142.19)
Week 188 Number Analyzed 4 participants
16442.50  (13180.44)
Week 192 Number Analyzed 2 participants
28750.00  (22415.28)
Week 196 Number Analyzed 2 participants
26850.00  (20152.54)
Week 200 Number Analyzed 1 participants
45000.00 [1]   (NA)
Week 204 Number Analyzed 1 participants
34500.00 [1]   (NA)
[1]
SD was not calculable for 1 participant.
29.Secondary Outcome
Title Serum Interleukin-6 (IL-6) Concentration During the DB Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 30 62
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 29 participants 62 participants
3.66  (6.49) 3.49  (5.14)
Week 2 Number Analyzed 30 participants 60 participants
5.90  (16.31) 30.14  (26.07)
Week 4 Number Analyzed 28 participants 61 participants
5.41  (10.02) 51.53  (126.49)
Week 8 Number Analyzed 26 participants 61 participants
3.30  (4.59) 30.88  (25.57)
Week 12 Number Analyzed 25 participants 53 participants
3.40  (4.21) 32.02  (24.91)
Week 16 Number Analyzed 23 participants 53 participants
3.72  (4.54) 28.59  (23.27)
Week 20 Number Analyzed 22 participants 55 participants
2.99  (2.88) 24.06  (19.59)
Week 24 Number Analyzed 20 participants 55 participants
3.68  (4.02) 26.27  (23.19)
Week 28 Number Analyzed 20 participants 53 participants
3.88  (4.24) 26.89  (24.01)
Week 32 Number Analyzed 22 participants 52 participants
3.43  (3.20) 33.29  (37.93)
Week 36 Number Analyzed 20 participants 50 participants
3.78  (3.65) 26.03  (21.75)
Week 40 Number Analyzed 19 participants 46 participants
4.82  (6.45) 24.16  (19.93)
Week 44 Number Analyzed 18 participants 46 participants
3.47  (3.65) 26.16  (20.39)
Week 48 Number Analyzed 17 participants 43 participants
4.58  (4.21) 29.61  (27.37)
Week 52 Number Analyzed 18 participants 44 participants
3.52  (3.36) 26.94  (22.26)
Week 56 Number Analyzed 15 participants 45 participants
4.13  (5.26) 33.15  (40.66)
Week 60 Number Analyzed 12 participants 43 participants
3.28  (3.65) 31.34  (25.38)
Week 64 Number Analyzed 14 participants 41 participants
4.08  (4.48) 30.60  (24.55)
Week 68 Number Analyzed 14 participants 41 participants
2.75  (3.35) 30.56  (44.67)
Week 72 Number Analyzed 12 participants 41 participants
2.95  (4.80) 23.16  (17.54)
Week 76 Number Analyzed 12 participants 42 participants
2.44  (3.04) 24.08  (16.78)
Week 80 Number Analyzed 11 participants 41 participants
1.57  (0.00) 24.86  (17.89)
Week 84 Number Analyzed 12 participants 40 participants
2.27  (1.84) 27.61  (23.04)
Week 88 Number Analyzed 9 participants 35 participants
1.57  (0.00) 26.51  (20.07)
Week 92 Number Analyzed 10 participants 31 participants
3.38  (4.80) 25.48  (17.24)
Week 96 Number Analyzed 7 participants 31 participants
1.57  (0.00) 24.57  (15.25)
Week 100 Number Analyzed 5 participants 18 participants
1.57  (0.00) 26.31  (18.74)
Week 104 Number Analyzed 7 participants 22 participants
1.57  (0.00) 26.30  (19.96)
Week 108 Number Analyzed 6 participants 21 participants
1.57  (0.00) 27.64  (23.97)
Week 112 Number Analyzed 3 participants 19 participants
1.57  (0.00) 27.39  (22.72)
Week 116 Number Analyzed 4 participants 15 participants
1.57  (0.00) 31.73  (23.27)
Week 120 Number Analyzed 3 participants 13 participants
1.57  (0.00) 55.92  (68.46)
Week 124 Number Analyzed 3 participants 15 participants
1.57  (0.00) 29.46  (19.49)
Week 128 Number Analyzed 2 participants 14 participants
1.57  (0.00) 31.20  (21.29)
Week 132 Number Analyzed 2 participants 15 participants
1.57  (0.00) 33.84  (34.36)
Week 136 Number Analyzed 2 participants 13 participants
1.57  (0.00) 51.83  (73.68)
Week 140 Number Analyzed 1 participants 12 participants
1.57 [1]   (NA) 41.00  (45.44)
Week 144 Number Analyzed 2 participants 11 participants
1.57  (0.00) 28.26  (25.64)
Week 148 Number Analyzed 2 participants 12 participants
1.57  (0.00) 28.76  (21.52)
Week 152 Number Analyzed 1 participants 12 participants
1.57 [1]   (NA) 28.07  (23.66)
Week 156 Number Analyzed 1 participants 11 participants
1.57 [1]   (NA) 27.25  (19.19)
Week 160 Number Analyzed 1 participants 11 participants
1.57 [1]   (NA) 29.60  (20.30)
Week 164 Number Analyzed 1 participants 11 participants
1.57 [1]   (NA) 34.00  (24.13)
Week 168 Number Analyzed 1 participants 10 participants
1.57 [1]   (NA) 26.29  (20.85)
Week 172 Number Analyzed 1 participants 7 participants
1.57 [1]   (NA) 23.57  (6.59)
Week 176 Number Analyzed 1 participants 7 participants
1.57 [1]   (NA) 27.73  (11.10)
Week 180 Number Analyzed 1 participants 7 participants
1.57 [1]   (NA) 24.09  (9.21)
Week 184 Number Analyzed 1 participants 6 participants
3.63 [1]   (NA) 17.34  (8.47)
Week 188 Number Analyzed 1 participants 4 participants
5.21 [1]   (NA) 17.78  (7.22)
Week 192 Number Analyzed 1 participants 2 participants
1.57 [1]   (NA) 16.55  (3.89)
Week 196 Number Analyzed 1 participants 2 participants
1.57 [1]   (NA) 14.45  (2.76)
Week 200 Number Analyzed 1 participants 1 participants
1.57 [1]   (NA) 36.90 [1]   (NA)
Week 204 Number Analyzed 1 participants 1 participants
1.57 [1]   (NA) 12.30 [1]   (NA)
Week 208 Number Analyzed 1 participants 0 participants
1.57 [1]   (NA)
Week 212 Number Analyzed 1 participants 0 participants
1.57 [1]   (NA)
Week 216 Number Analyzed 1 participants 0 participants
1.57 [1]   (NA)
[1]
SD was not calculable for 1 participant.
30.Secondary Outcome
Title Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 62
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 32 participants 62 participants
31.88  (7.50) 33.18  (7.72)
Week 2 Number Analyzed 30 participants 61 participants
32.72  (8.09) 396.49  (80.09)
Week 4 Number Analyzed 29 participants 61 participants
44.79  (64.73) 509.21  (121.99)
Week 8 Number Analyzed 27 participants 61 participants
33.23  (7.21) 560.63  (164.11)
Week 12 Number Analyzed 26 participants 55 participants
33.02  (7.65) 582.36  (169.71)
Week 16 Number Analyzed 24 participants 53 participants
31.60  (8.18) 582.22  (204.20)
Week 20 Number Analyzed 22 participants 55 participants
32.99  (8.14) 555.64  (210.76)
Week 24 Number Analyzed 20 participants 55 participants
32.47  (8.69) 573.01  (217.93)
Week 28 Number Analyzed 20 participants 53 participants
31.83  (9.71) 565.29  (219.88)
Week 32 Number Analyzed 22 participants 52 participants
33.33  (9.97) 564.13  (215.59)
Week 36 Number Analyzed 20 participants 50 participants
34.03  (7.79) 572.31  (207.35)
Week 40 Number Analyzed 19 participants 46 participants
33.64  (9.44) 554.90  (241.34)
Week 44 Number Analyzed 18 participants 46 participants
33.97  (9.05) 585.62  (219.45)
Week 48 Number Analyzed 17 participants 44 participants
33.72  (8.18) 591.06  (213.04)
Week 52 Number Analyzed 18 participants 44 participants
33.47  (7.58) 575.56  (210.84)
Week 56 Number Analyzed 15 participants 45 participants
30.34  (5.21) 585.40  (233.38)
Week 60 Number Analyzed 13 participants 43 participants
30.58  (6.81) 586.40  (226.21)
Week 64 Number Analyzed 14 participants 42 participants
32.27  (7.63) 602.72  (239.25)
Week 68 Number Analyzed 14 participants 41 participants
31.19  (7.23) 617.80  (244.63)
Week 72 Number Analyzed 13 participants 42 participants
31.12  (7.76) 543.95  (224.00)
Week 76 Number Analyzed 12 participants 42 participants
30.56  (7.06) 558.67  (234.41)
Week 80 Number Analyzed 11 participants 41 participants
33.36  (9.91) 558.73  (235.60)
Week 84 Number Analyzed 12 participants 40 participants
30.95  (8.96) 552.37  (226.76)
Week 88 Number Analyzed 10 participants 35 participants
32.05  (7.23) 547.93  (211.74)
Week 92 Number Analyzed 10 participants 32 participants
28.93  (5.72) 580.64  (201.78)
Week 96 Number Analyzed 8 participants 31 participants
32.88  (5.62) 561.64  (205.00)
Week 100 Number Analyzed 7 participants 19 participants
31.84  (7.62) 559.18  (194.43)
Week 104 Number Analyzed 7 participants 22 participants
31.70  (8.81) 598.05  (192.99)
Week 108 Number Analyzed 6 participants 21 participants
30.55  (6.94) 592.06  (193.20)
Week 112 Number Analyzed 4 participants 19 participants
29.93  (8.47) 603.31  (227.68)
Week 116 Number Analyzed 4 participants 15 participants
34.30  (13.37) 609.37  (198.61)
Week 120 Number Analyzed 3 participants 13 participants
38.20  (10.96) 625.15  (229.67)
Week 124 Number Analyzed 3 participants 15 participants
37.87  (13.59) 580.07  (240.15)
Week 128 Number Analyzed 2 participants 15 participants
44.50  (2.40) 574.54  (214.94)
Week 132 Number Analyzed 2 participants 15 participants
29.80  (8.63) 575.40  (213.45)
Week 136 Number Analyzed 2 participants 13 participants
29.45  (11.53) 593.92  (209.84)
Week 140 Number Analyzed 1 participants 13 participants
37.20 [1]   (NA) 627.32  (232.08)
Week 144 Number Analyzed 2 participants 11 participants
31.10  (10.18) 693.82  (239.70)
Week 148 Number Analyzed 2 participants 12 participants
28.55  (13.08) 690.83  (142.94)
Week 152 Number Analyzed 1 participants 12 participants
33.60 [1]   (NA) 626.41  (229.59)
Week 156 Number Analyzed 1 participants 11 participants
39.90 [1]   (NA) 682.82  (156.88)
Week 160 Number Analyzed 1 participants 11 participants
45.00 [1]   (NA) 694.18  (127.92)
Week 164 Number Analyzed 1 participants 11 participants
43.00 [1]   (NA) 696.18  (106.76)
Week 168 Number Analyzed 1 participants 10 participants
40.60 [1]   (NA) 681.00  (122.60)
Week 172 Number Analyzed 1 participants 7 participants
49.70 [1]   (NA) 672.71  (107.83)
Week 176 Number Analyzed 1 participants 7 participants
45.50 [1]   (NA) 700.71  (90.64)
Week 180 Number Analyzed 1 participants 7 participants
55.60 [1]   (NA) 702.00  (75.60)
Week 184 Number Analyzed 1 participants 6 participants
41.60 [1]   (NA) 678.33  (78.20)
Week 188 Number Analyzed 1 participants 4 participants
40.00 [1]   (NA) 688.75  (143.82)
Week 192 Number Analyzed 1 participants 2 participants
43.40 [1]   (NA) 668.00  (192.33)
Week 196 Number Analyzed 1 participants 2 participants
38.00 [1]   (NA) 630.00  (141.42)
Week 200 Number Analyzed 1 participants 1 participants
35.80 [1]   (NA) 815.00 [1]   (NA)
Week 204 Number Analyzed 1 participants 1 participants
33.70 [1]   (NA) 783.00 [1]   (NA)
Week 208 Number Analyzed 1 participants 0 participants
35.60 [1]   (NA)
Week 212 Number Analyzed 1 participants 0 participants
30.50 [1]   (NA)
Week 216 Number Analyzed 1 participants 0 participants
37.60 [1]   (NA)
[1]
SD was not calculable for 1 participant.
31.Secondary Outcome
Title Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 32 63
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 32 participants 63 participants
3.08  (3.77) 4.95  (8.67)
Week 2 Number Analyzed 30 participants 62 participants
3.51  (4.55) 0.93  (2.35)
Week 4 Number Analyzed 29 participants 60 participants
3.45  (6.24) 0.82  (1.64)
Week 8 Number Analyzed 27 participants 61 participants
4.56  (8.97) 0.83  (1.99)
Week 12 Number Analyzed 26 participants 55 participants
4.23  (7.23) 1.23  (3.19)
Week 16 Number Analyzed 24 participants 53 participants
5.30  (9.17) 1.56  (4.53)
Week 20 Number Analyzed 22 participants 55 participants
4.07  (5.20) 1.78  (3.72)
Week 24 Number Analyzed 19 participants 55 participants
3.53  (4.08) 1.72  (4.05)
Week 28 Number Analyzed 20 participants 53 participants
5.85  (9.99) 2.35  (5.61)
Week 32 Number Analyzed 22 participants 52 participants
3.97  (5.20) 2.06  (4.28)
Week 36 Number Analyzed 20 participants 50 participants
3.77  (4.40) 1.56  (3.36)
Week 40 Number Analyzed 18 participants 45 participants
6.77  (10.92) 2.55  (5.53)
Week 44 Number Analyzed 18 participants 46 participants
5.44  (8.72) 3.31  (11.31)
Week 48 Number Analyzed 17 participants 44 participants
4.70  (5.43) 1.79  (3.24)
Week 52 Number Analyzed 18 participants 42 participants
3.82  (4.75) 1.90  (3.69)
Week 56 Number Analyzed 15 participants 45 participants
5.33  (8.87) 2.32  (5.44)
Week 60 Number Analyzed 13 participants 43 participants
4.54  (5.60) 3.20  (11.86)
Week 64 Number Analyzed 14 participants 43 participants
3.76  (4.62) 1.92  (3.55)
Week 68 Number Analyzed 14 participants 42 participants
3.30  (5.11) 3.65  (8.52)
Week 72 Number Analyzed 13 participants 42 participants
5.07  (11.87) 3.33  (7.30)
Week 76 Number Analyzed 12 participants 42 participants
1.98  (2.12) 2.79  (6.54)
Week 80 Number Analyzed 11 participants 41 participants
1.10  (0.72) 2.83  (7.09)
Week 84 Number Analyzed 12 participants 40 participants
2.31  (4.66) 3.81  (10.18)
Week 88 Number Analyzed 10 participants 35 participants
1.94  (3.38) 2.64  (6.56)
Week 92 Number Analyzed 10 participants 32 participants
4.49  (10.18) 1.94  (4.11)
Week 96 Number Analyzed 8 participants 31 participants
1.76  (2.47) 1.64  (3.37)
Week 100 Number Analyzed 7 participants 20 participants
0.90  (0.87) 1.87  (4.28)
Week 104 Number Analyzed 7 participants 22 participants
1.13  (1.01) 1.93  (4.43)
Week 108 Number Analyzed 6 participants 21 participants
2.20  (3.16) 2.56  (7.40)
Week 112 Number Analyzed 4 participants 19 participants
2.25  (2.68) 1.53  (2.86)
Week 116 Number Analyzed 4 participants 15 participants
2.28  (3.41) 1.19  (1.93)
Week 120 Number Analyzed 2 participants 14 participants
1.55  (1.63) 6.05  (14.33)
Week 124 Number Analyzed 3 participants 15 participants
1.50  (1.04) 3.24  (8.32)
Week 128 Number Analyzed 2 participants 15 participants
0.65  (0.64) 3.09  (7.52)
Week 132 Number Analyzed 2 participants 15 participants
2.55  (1.77) 2.66  (5.04)
Week 136 Number Analyzed 2 participants 15 participants
2.70  (1.27) 2.85  (7.29)
Week 140 Number Analyzed 1 participants 13 participants
2.50 [1]   (NA) 4.54  (9.57)
Week 144 Number Analyzed 2 participants 11 participants
2.65  (2.19) 0.96  (1.75)
Week 148 Number Analyzed 2 participants 12 participants
4.80  (0.99) 0.87  (1.44)
Week 152 Number Analyzed 1 participants 12 participants
1.20 [1]   (NA) 0.79  (0.79)
Week 156 Number Analyzed 1 participants 11 participants
1.80 [1]   (NA) 0.71  (1.17)
Week 160 Number Analyzed 1 participants 11 participants
1.20 [1]   (NA) 0.82  (1.36)
Week 164 Number Analyzed 1 participants 11 participants
1.30 [1]   (NA) 0.54  (0.50)
Week 168 Number Analyzed 1 participants 10 participants
1.30 [1]   (NA) 0.37  (0.22)
Week 172 Number Analyzed 1 participants 7 participants
1.30 [1]   (NA) 0.19  (0.09)
Week 176 Number Analyzed 1 participants 7 participants
1.30 [1]   (NA) 0.25  (0.17)
Week 180 Number Analyzed 1 participants 7 participants
1.20 [1]   (NA) 0.27  (0.16)
Week 184 Number Analyzed 1 participants 6 participants
1.10 [1]   (NA) 0.22  (0.11)
Week 188 Number Analyzed 1 participants 4 participants
2.40 [1]   (NA) 0.21  (0.13)
Week 192 Number Analyzed 1 participants 2 participants
1.10 [1]   (NA) 0.33  (0.25)
Week 196 Number Analyzed 1 participants 2 participants
2.00 [1]   (NA) 0.15  (0.00)
Week 200 Number Analyzed 1 participants 1 participants
1.10 [1]   (NA) 0.50 [1]   (NA)
Week 204 Number Analyzed 0 participants 1 participants
0.15 [1]   (NA)
Week 208 Number Analyzed 1 participants 0 participants
1.00 [1]   (NA)
Week 212 Number Analyzed 1 participants 0 participants
1.60 [1]   (NA)
Week 216 Number Analyzed 1 participants 0 participants
1.10 [1]   (NA)
[1]
SD was not calculable for 1 participant.
32.Secondary Outcome
Title Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Drift in the anti-AQP4 antibody titer cell-based assay over time confounded longitudinal assessment of anti-AQP4 antibody titers and therefore these results cannot be reported
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Percentage of Blood Plasmablasts Over Time
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The plasmablast assay lacked the sensitivity required to measure plasmablast levels at baseline in the majority of participants. Since most participants had plasmablast values below lower limit of quantitation (LLOQ) at baseline, longitudinal assessments could not be performed and therefore plasmablast results are not reported.
Arm/Group Title Placebo Satralizumab
Hide Arm/Group Description:
Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
34.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period
Hide Description Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.
Time Frame Up to approximately Week 216
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from SAF who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Data was summarized together for this outcome measure.
Arm/Group Title Satralizumab
Hide Arm/Group Description:
Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: percentage of participants
71.4
Time Frame Up to clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks)
Adverse Event Reporting Description The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
 
Arm/Group Title Placebo, DB Period Satralizumab, DB Period Placebo, Then Satralizumab, OLE Period Satralizumab, Then Satralizumab, OLE Period
Hide Arm/Group Description Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD).
All-Cause Mortality
Placebo, DB Period Satralizumab, DB Period Placebo, Then Satralizumab, OLE Period Satralizumab, Then Satralizumab, OLE Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/63 (0.00%)      0/17 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Placebo, DB Period Satralizumab, DB Period Placebo, Then Satralizumab, OLE Period Satralizumab, Then Satralizumab, OLE Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/32 (15.63%)      12/63 (19.05%)      1/17 (5.88%)      4/18 (22.22%)    
Cardiac disorders         
Acute myocardial infarction  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Bradycardia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Eye disorders         
Visual impairment  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders         
Enterocolitis  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Nausea  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
General disorders         
Hypothermia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Non-cardiac chest pain  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations         
Cystitis  1  1/32 (3.13%)  1 0/63 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0
Influenza  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 0/18 (0.00%)  0
Pneumonia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Pulmonary sepsis  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Pyelonephritis  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Upper respiratory tract infection  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Urinary tract infection  1  1/32 (3.13%)  2 0/63 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0
Urosepsis  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications         
Injury  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Post procedural haematoma  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Radius fracture  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders         
Cervical radiculopathy  1  1/32 (3.13%)  1 0/63 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0
Intracranial aneurysm  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Neuromyelitis optica  1  1/32 (3.13%)  1 0/63 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders         
Mental status changes  1  0/32 (0.00%)  0 2/63 (3.17%)  3 0/17 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Apnoea  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Pulmonary oedema  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo, DB Period Satralizumab, DB Period Placebo, Then Satralizumab, OLE Period Satralizumab, Then Satralizumab, OLE Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/32 (68.75%)      52/63 (82.54%)      16/17 (94.12%)      18/18 (100.00%)    
Blood and lymphatic system disorders         
Neutropenia  1  1/32 (3.13%)  9 4/63 (6.35%)  5 1/17 (5.88%)  1 1/18 (5.56%)  1
Lymphadenopathy  1  0/32 (0.00%)  0 1/63 (1.59%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0
Lymphopenia  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Cardiac disorders         
Bradycardia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Coronary artery disease  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Tachycardia  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 2/18 (11.11%)  2
Ear and labyrinth disorders         
Deafness unilateral  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Ear canal erythema  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Ear pain  1  1/32 (3.13%)  1 1/63 (1.59%)  1 0/17 (0.00%)  0 2/18 (11.11%)  3
Ear pruritus  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Vertigo  1  0/32 (0.00%)  0 3/63 (4.76%)  5 0/17 (0.00%)  0 2/18 (11.11%)  3
Eye disorders         
Vision blurred  1  2/32 (6.25%)  2 0/63 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0
Abnormal sensation in eye  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Blepharitis  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Dry eye  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Eye pain  1  0/32 (0.00%)  0 2/63 (3.17%)  4 0/17 (0.00%)  0 1/18 (5.56%)  1
Eye pruritus  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Ocular hypertension  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Photopsia  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders         
Abdominal pain  1  2/32 (6.25%)  3 1/63 (1.59%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Abdominal pain upper  1  1/32 (3.13%)  1 1/63 (1.59%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0
Constipation  1  2/32 (6.25%)  2 3/63 (4.76%)  3 3/17 (17.65%)  3 2/18 (11.11%)  2
Diarrhoea  1  0/32 (0.00%)  0 5/63 (7.94%)  19 0/17 (0.00%)  0 3/18 (16.67%)  17
Gastrooesophageal reflux disease  1  2/32 (6.25%)  2 1/63 (1.59%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Gingival pain  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Nausea  1  2/32 (6.25%)  6 11/63 (17.46%)  15 3/17 (17.65%)  7 6/18 (33.33%)  8
Abdominal tenderness  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Aphthous stomatitis  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 2/18 (11.11%)  2
Coeliac disease  1  0/32 (0.00%)  0 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Enteritis  1  0/32 (0.00%)  0 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Flatulence  1  1/32 (3.13%)  1 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Food poisoning  1  1/32 (3.13%)  1 1/63 (1.59%)  1 1/17 (5.88%)  2 0/18 (0.00%)  0
Haematochezia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Haemorrhoidal haemorrhage  1  0/32 (0.00%)  0 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Haemorroids  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 3/18 (16.67%)  3
Toothache  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Vomiting  1  1/32 (3.13%)  1 3/63 (4.76%)  3 0/17 (0.00%)  0 1/18 (5.56%)  1
General disorders         
Fatigue  1  2/32 (6.25%)  3 7/63 (11.11%)  9 1/17 (5.88%)  1 2/18 (11.11%)  2
Influenza like illness  1  1/32 (3.13%)  3 2/63 (3.17%)  5 1/17 (5.88%)  1 2/18 (11.11%)  15
Injection site erythema  1  2/32 (6.25%)  3 0/63 (0.00%)  0 1/17 (5.88%)  2 0/18 (0.00%)  0
Oedema peripheral  1  0/32 (0.00%)  0 4/63 (6.35%)  4 1/17 (5.88%)  1 1/18 (5.56%)  2
Feeling cold  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Injection site bruising  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Injection site pain  1  0/32 (0.00%)  0 2/63 (3.17%)  3 1/17 (5.88%)  1 1/18 (5.56%)  1
Oedema  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Pain  1  1/32 (3.13%)  1 2/63 (3.17%)  2 0/17 (0.00%)  0 2/18 (11.11%)  2
Pyrexia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Swelling  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/32 (0.00%)  0 1/63 (1.59%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  0/32 (0.00%)  0 1/63 (1.59%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Smoke sensitivity  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Infections and infestations         
Bronchitis  1  2/32 (6.25%)  2 2/63 (3.17%)  2 0/17 (0.00%)  0 0/18 (0.00%)  0
Cellulitis  1  0/32 (0.00%)  0 4/63 (6.35%)  4 0/17 (0.00%)  0 0/18 (0.00%)  0
Gastroenteritis  1  0/32 (0.00%)  0 3/63 (4.76%)  3 0/17 (0.00%)  0 2/18 (11.11%)  3
Influenza  1  2/32 (6.25%)  3 3/63 (4.76%)  3 1/17 (5.88%)  1 1/18 (5.56%)  1
Nasopharyngitis  1  1/32 (3.13%)  1 9/63 (14.29%)  11 2/17 (11.76%)  2 2/18 (11.11%)  3
Oral candidiasis  1  2/32 (6.25%)  3 0/63 (0.00%)  0 1/17 (5.88%)  2 0/18 (0.00%)  0
Tonsillitis  1  1/32 (3.13%)  1 0/63 (0.00%)  0 2/17 (11.76%)  2 0/18 (0.00%)  0
Tooth abscess  1  2/32 (6.25%)  2 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Upper respiratory tract infection  1  6/32 (18.75%)  14 10/63 (15.87%)  20 4/17 (23.53%)  11 7/18 (38.89%)  24
Urinary tract infection  1  8/32 (25.00%)  22 11/63 (17.46%)  35 3/17 (17.65%)  10 3/18 (16.67%)  3
Conjunctivitis infective  1  1/32 (3.13%)  1 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Cystitis  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Ear infection  1  1/32 (3.13%)  1 2/63 (3.17%)  2 1/17 (5.88%)  1 1/18 (5.56%)  1
Febrile infection  1  0/32 (0.00%)  0 1/63 (1.59%)  1 0/17 (0.00%)  0 1/18 (5.56%)  1
Fungal infection  1  0/32 (0.00%)  0 2/63 (3.17%)  2 0/17 (0.00%)  0 1/18 (5.56%)  1
Oral herpes  1  1/32 (3.13%)  1 1/63 (1.59%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0
Otitis media  1  0/32 (0.00%)  0 0/63 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Pyelonephritis  1  0/32 (0.00%)  0 0/63 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Sinusitis  1  0/32 (0.00%)  0 2/63 (3.17%)  3 0/17 (0.00%)  0 1/18 (5.56%)  1
Viral upper respiratory tract infection  1  0/32 (0.00%)  0 0/63 (0.00%)  0 1/17 (5.88%)  4 1/18 (5.56%)  2
Vulvovaginal mycotic infection  1  1/32 (3.13%)  1 1/63 (1.59%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion  1  1/32 (3.13%)  1 3/63 (4.76%)  3 2/17 (11.76%)  2 2/18 (11.11%)  2
Excoriation  1  2/32 (6.25%)  2 1/63 (1.59%)  1 1/17 (5.88%)  1 1/18 (5.56%)  1
Fall  1  2/32 (6.25%)  2 4/63 (6.35%)  4 0/17 (0.00%)  0 3/18 (16.67%)  5
Arthropod bite  1