Trial Outcomes & Findings for Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) (NCT NCT02073279)
NCT ID: NCT02073279
Last Updated: 2023-03-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
Up to Week 216
Results posted on
2023-03-01
Participant Flow
The Double-blind (DB) period lasted up to the primary 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 Open Label Period lasted up to clinical cut-off date (31-Jan-2022).
Participants with neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD) were randomized 2:1 to receive either satralizumab 120 mg or matching placebo.
Participant milestones
| Measure |
Placebo, Then Satralizumab
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.
|
Satralizumab, Then Satralizumab
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Double-blind Period
STARTED
|
32
|
63
|
|
Double-blind Period
COMPLETED
|
28
|
56
|
|
Double-blind Period
NOT COMPLETED
|
4
|
7
|
|
Open-label Extension Period
STARTED
|
28
|
56
|
|
Open-label Extension Period
COMPLETED
|
21
|
41
|
|
Open-label Extension Period
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
Placebo, Then Satralizumab
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.
|
Satralizumab, Then Satralizumab
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Double-blind Period
Adverse Event
|
1
|
1
|
|
Double-blind Period
Switched to another treatment
|
1
|
2
|
|
Double-blind Period
Protocol Violation
|
0
|
1
|
|
Double-blind Period
Refused Treatment/Did Not Cooperate
|
0
|
1
|
|
Double-blind Period
Withdrawal by Subject
|
2
|
2
|
|
Open-label Extension Period
Adverse Event
|
1
|
0
|
|
Open-label Extension Period
Lack of Efficacy
|
1
|
0
|
|
Open-label Extension Period
Lost to Follow-up
|
0
|
4
|
|
Open-label Extension Period
Switched to another treatment
|
1
|
4
|
|
Open-label Extension Period
Protocol Violation
|
0
|
1
|
|
Open-label Extension Period
Refused Treatment/Did Not Cooperate
|
0
|
1
|
|
Open-label Extension Period
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Baseline characteristics by cohort
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
43.7 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period
|
128.3 weeks
Interval 29.9 to
Upper limit of CI was not reached due to low number of participants with events.
|
NA weeks
Interval 135.7 to
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.
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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).
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period
Baseline
|
27.563 score on scale
Standard Error 5.438
|
31.661 score on scale
Standard Error 3.665
|
|
Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period
Change from Baseline to Week 24
|
-5.949 score on scale
Standard Error 4.832
|
-2.735 score on scale
Standard Error 4.260
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period
Change from Baseline to Week 24
|
3.602 score on scale
Standard Error 1.820
|
5.709 score on scale
Standard Error 1.610
|
|
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period
Baseline
|
29.656 score on scale
Standard Error 2.280
|
30.590 score on scale
Standard Error 1.492
|
SECONDARY outcome
Timeframe: Up to Week 216Population: ITT population included all participants randomized to the treatment groups.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=23 Participants
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.
|
Satralizumab, Then Satralizumab
n=56 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Relapse-Free Rate During the DB Period
Week 12
|
74.87 percentage of participants
|
88.89 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 24
|
71.61 percentage of participants
|
85.71 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 36
|
61.85 percentage of participants
|
79.37 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 48
|
61.85 percentage of participants
|
76.13 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 72
|
51.21 percentage of participants
|
74.40 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 96
|
51.21 percentage of participants
|
72.14 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 120
|
51.21 percentage of participants
|
72.14 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 144
|
34.14 percentage of participants
|
62.80 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 168
|
34.14 percentage of participants
|
62.80 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 192
|
34.14 percentage of participants
|
62.80 percentage of participants
|
|
Relapse-Free Rate During the DB Period
Week 216
|
34.14 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 216Population: ITT population included all participants randomized to the treatment groups.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Annualized Relapse Rate (ARR) During the DB Period
|
0.41 patients w PDRs/patient-years at risk
Interval 0.24 to 0.67
|
0.17 patients w PDRs/patient-years at risk
Interval 0.1 to 0.26
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
1.75 score on scale
Standard Deviation 5.42
|
1.36 score on scale
Standard Deviation 8.89
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
42.86 score on scale
Standard Deviation 11.28
|
43.20 score on scale
Standard Deviation 11.08
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-0.89 score on scale
Standard Deviation 8.35
|
-0.13 score on scale
Standard Deviation 8.09
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
3.19 score on scale
Standard Deviation 8.04
|
0.91 score on scale
Standard Deviation 9.23
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
3.43 score on scale
Standard Deviation 5.60
|
2.38 score on scale
Standard Deviation 7.82
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
0.00 score on scale
Standard Deviation 8.07
|
0.53 score on scale
Standard Deviation 6.21
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-2.22 score on scale
Standard Deviation 8.84
|
2.59 score on scale
Standard Deviation 6.66
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
0.80 score on scale
Standard Deviation NA
Standard Deviation (SD) was not calculable for 1 participant.
|
4.19 score on scale
Standard Deviation 7.01
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-8.47 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
0 score on scale
Standard Deviation 0
|
|
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-12.50 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-0.52 score on scale
Standard Deviation 9.96
|
0.49 score on scale
Standard Deviation 6.46
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
8.72 score on scale
Standard Deviation 13.55
|
3.60 score on scale
Standard Deviation 7.02
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
5.23 score on scale
Standard Deviation 14.11
|
2.82 score on scale
Standard Deviation 8.00
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-4.75 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
8.32 score on scale
Standard Deviation 11.77
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
6.60 score on scale
Standard Deviation 9.10
|
3.45 score on scale
Standard Deviation 6.42
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
39.43 score on scale
Standard Deviation 9.50
|
39.72 score on scale
Standard Deviation 10.41
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
1.85 score on scale
Standard Deviation 9.72
|
1.01 score on scale
Standard Deviation 7.61
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
4.83 score on scale
Standard Deviation 12.41
|
3.21 score on scale
Standard Deviation 6.57
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-7.13 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
5.04 score on scale
Standard Deviation 9.45
|
|
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-4.75 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-2.62 score on scale
Standard Deviation 6.92
|
0.82 score on scale
Standard Deviation 10.32
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-2.62 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
42.86 score on scale
Standard Deviation 12.69
|
46.78 score on scale
Standard Deviation 10.10
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
0.79 score on scale
Standard Deviation 9.02
|
1.84 score on scale
Standard Deviation 7.05
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
-0.58 score on scale
Standard Deviation 7.32
|
2.67 score on scale
Standard Deviation 7.89
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
2.62 score on scale
Standard Deviation 6.32
|
1.95 score on scale
Standard Deviation 7.85
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-3.60 score on scale
Standard Deviation 6.08
|
2.36 score on scale
Standard Deviation 7.38
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
1.31 score on scale
Standard Deviation 1.85
|
2.83 score on scale
Standard Deviation 9.43
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
5.23 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
2.62 score on scale
Standard Deviation 8.89
|
|
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-13.08 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-3.93 score on scale
Standard Deviation 12.95
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
38.70 score on scale
Standard Deviation 12.24
|
39.48 score on scale
Standard Deviation 10.99
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
2.20 score on scale
Standard Deviation 4.62
|
1.96 score on scale
Standard Deviation 6.12
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
6.62 score on scale
Standard Deviation 9.71
|
2.99 score on scale
Standard Deviation 6.94
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
7.01 score on scale
Standard Deviation 8.63
|
1.94 score on scale
Standard Deviation 8.05
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
4.79 score on scale
Standard Deviation 9.48
|
3.19 score on scale
Standard Deviation 10.87
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
1.91 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.96 score on scale
Standard Deviation 8.62
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-1.92 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
4.78 score on scale
Standard Deviation 4.06
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-3.83 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
2.34 score on scale
Standard Deviation 6.90
|
3.33 score on scale
Standard Deviation 6.76
|
|
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
5.50 score on scale
Standard Deviation 9.62
|
3.59 score on scale
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
4.55 score on scale
Standard Deviation 7.96
|
3.89 score on scale
Standard Deviation 9.22
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
3.05 score on scale
Standard Deviation 11.98
|
1.12 score on scale
Standard Deviation 11.87
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-12.77 score on scale
Standard Deviation 14.07
|
1.31 score on scale
Standard Deviation 14.04
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-12.19 score on scale
Standard Deviation 17.23
|
1.74 score on scale
Standard Deviation 13.40
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
0.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.35 score on scale
Standard Deviation 11.89
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-13.93 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-3.49 score on scale
Standard Deviation 4.93
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-10.45 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
42.24 score on scale
Standard Deviation 13.09
|
42.07 score on scale
Standard Deviation 13.62
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-1.57 score on scale
Standard Deviation 15.67
|
3.87 score on scale
Standard Deviation 11.27
|
|
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.78 score on scale
Standard Deviation 8.57
|
2.73 score on scale
Standard Deviation 10.30
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
3.14 score on scale
Standard Deviation 9.92
|
3.52 score on scale
Standard Deviation 8.38
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
37.86 score on scale
Standard Deviation 11.28
|
37.43 score on scale
Standard Deviation 11.55
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
4.12 score on scale
Standard Deviation 7.24
|
5.01 score on scale
Standard Deviation 8.25
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
5.70 score on scale
Standard Deviation 7.65
|
4.59 score on scale
Standard Deviation 8.56
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
5.62 score on scale
Standard Deviation 6.35
|
4.83 score on scale
Standard Deviation 8.31
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
2.25 score on scale
Standard Deviation 8.99
|
3.18 score on scale
Standard Deviation 9.46
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-3.37 score on scale
Standard Deviation 11.12
|
2.43 score on scale
Standard Deviation 8.80
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
0.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.00 score on scale
Standard Deviation 9.10
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-6.74 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
4.49 score on scale
Standard Deviation 6.35
|
|
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-17.97 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
0.63 score on scale
Standard Deviation 1.77
|
3.56 score on scale
Standard Deviation 7.89
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-5.01 score on scale
Standard Deviation 13.26
|
0.31 score on scale
Standard Deviation 8.48
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
7.52 score on scale
Standard Deviation 10.63
|
3.76 score on scale
Standard Deviation 14.68
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-5.01 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-1.50 score on scale
Standard Deviation 7.86
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-5.01 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-2.51 score on scale
Standard Deviation 3.54
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
0.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
42.93 score on scale
Standard Deviation 13.22
|
41.01 score on scale
Standard Deviation 11.66
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
1.76 score on scale
Standard Deviation 12.42
|
2.42 score on scale
Standard Deviation 9.63
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.56 score on scale
Standard Deviation 10.59
|
2.62 score on scale
Standard Deviation 8.17
|
|
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
0.39 score on scale
Standard Deviation 11.66
|
3.96 score on scale
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Baseline
|
40.72 score on scale
Standard Deviation 11.86
|
46.02 score on scale
Standard Deviation 10.58
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
3.43 score on scale
Standard Deviation 9.38
|
3.68 score on scale
Standard Deviation 6.43
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
0.00 score on scale
Standard Deviation 7.94
|
4.34 score on scale
Standard Deviation 9.39
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-1.98 score on scale
Standard Deviation 11.24
|
3.96 score on scale
Standard Deviation 9.94
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-5.94 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
5.05 score on scale
Standard Deviation 6.58
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-11.88 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.00 score on scale
Standard Deviation 8.40
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-11.88 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
1.49 score on scale
Standard Deviation 10.22
|
2.33 score on scale
Standard Deviation 8.29
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
4.79 score on scale
Standard Deviation 9.07
|
4.15 score on scale
Standard Deviation 7.49
|
|
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-9.41 score on scale
Standard Deviation 7.70
|
4.95 score on scale
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Baseline
|
44.03 score on scale
Standard Deviation 13.93
|
46.43 score on scale
Standard Deviation 11.55
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-0.28 score on scale
Standard Deviation 11.19
|
2.89 score on scale
Standard Deviation 8.96
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.09 score on scale
Standard Deviation 8.96
|
2.63 score on scale
Standard Deviation 8.04
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
1.54 score on scale
Standard Deviation 8.18
|
3.17 score on scale
Standard Deviation 7.70
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-2.65 score on scale
Standard Deviation 6.05
|
1.91 score on scale
Standard Deviation 9.32
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-10.65 score on scale
Standard Deviation 11.99
|
1.03 score on scale
Standard Deviation 12.92
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-5.40 score on scale
Standard Deviation 8.41
|
2.98 score on scale
Standard Deviation 12.99
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-14.38 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-5.88 score on scale
Standard Deviation 7.54
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-4.22 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-0.61 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
1.63 score on scale
Standard Deviation 11.86
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Baseline
|
38.89 score on scale
Standard Deviation 11.20
|
38.59 score on scale
Standard Deviation 9.68
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
1.78 score on scale
Standard Deviation 4.99
|
1.05 score on scale
Standard Deviation 6.14
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
3.57 score on scale
Standard Deviation 4.94
|
2.85 score on scale
Standard Deviation 4.90
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
5.68 score on scale
Standard Deviation 7.32
|
2.87 score on scale
Standard Deviation 6.80
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
7.25 score on scale
Standard Deviation 7.08
|
4.20 score on scale
Standard Deviation 5.90
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
8.95 score on scale
Standard Deviation 8.51
|
2.68 score on scale
Standard Deviation 8.72
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
3.18 score on scale
Standard Deviation 10.67
|
2.89 score on scale
Standard Deviation 7.11
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-1.79 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
7.24 score on scale
Standard Deviation 3.35
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-10.84 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-2.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
1.83 score on scale
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Baseline
|
0.7153 score on scale
Standard Deviation 0.2253
|
0.6881 score on scale
Standard Deviation 0.2040
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
0.0031 score on scale
Standard Deviation 0.1602
|
0.0188 score on scale
Standard Deviation 0.1812
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.0016 score on scale
Standard Deviation 0.1176
|
0.0244 score on scale
Standard Deviation 0.1571
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
0.0582 score on scale
Standard Deviation 0.1498
|
0.0238 score on scale
Standard Deviation 0.1323
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
0.0447 score on scale
Standard Deviation 0.1508
|
0.0460 score on scale
Standard Deviation 0.1067
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-0.0288 score on scale
Standard Deviation 0.1908
|
0.0099 score on scale
Standard Deviation 0.1636
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-0.1001 score on scale
Standard Deviation 0.1416
|
0.0063 score on scale
Standard Deviation 0.2299
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
0.0000 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.0261 score on scale
Standard Deviation 0.2532
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-0.2002 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.0299 score on scale
Standard Deviation 0.0423
|
|
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-0.2002 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=29 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
0.0489 1/seconds
Standard Deviation 0.0301
|
0.0063 1/seconds
Standard Deviation 0.0386
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Baseline
|
0.1442 1/seconds
Standard Deviation 0.0793
|
0.1355 1/seconds
Standard Deviation 0.0561
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
0.0030 1/seconds
Standard Deviation 0.0374
|
0.0040 1/seconds
Standard Deviation 0.0225
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.0142 1/seconds
Standard Deviation 0.0493
|
0.0115 1/seconds
Standard Deviation 0.0306
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
0.0205 1/seconds
Standard Deviation 0.0531
|
0.0071 1/seconds
Standard Deviation 0.0257
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-0.0031 1/seconds
Standard Deviation 0.0251
|
0.0081 1/seconds
Standard Deviation 0.0253
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
0.0388 1/seconds
Standard Deviation 0.0572
|
0.0003 1/seconds
Standard Deviation 0.0443
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-0.0656 1/seconds
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.0155 1/seconds
Standard Deviation 0.0379
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-0.0812 1/seconds
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.0304 1/seconds
Standard Deviation 0.0360
|
|
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-0.0917 1/seconds
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
-0.08 score on scale
Standard Deviation 1.04
|
-0.12 score on scale
Standard Deviation 0.63
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-0.38 score on scale
Standard Deviation 0.74
|
-0.42 score on scale
Standard Deviation 0.99
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-1.00 score on scale
Standard Deviation 0.00
|
-0.13 score on scale
Standard Deviation 0.81
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-1.00 score on scale
Standard Deviation 1.41
|
-0.09 score on scale
Standard Deviation 0.54
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
—
|
0.00 score on scale
Standard Deviation 0.67
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
-1.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.50 score on scale
Standard Deviation 2.12
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Baseline
|
1.66 score on scale
Standard Deviation 1.00
|
1.97 score on scale
Standard Deviation 0.98
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-0.05 score on scale
Standard Deviation 0.40
|
-0.04 score on scale
Standard Deviation 0.64
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
0.00 score on scale
Standard Deviation 0.94
|
-0.13 score on scale
Standard Deviation 0.78
|
|
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-1.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 120Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=7 Participants
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.
|
Satralizumab, Then Satralizumab
n=8 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Baseline
|
19.43 score on scale
Standard Deviation 12.19
|
11.32 score on scale
Standard Deviation 7.20
|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
0.00 score on scale
Standard Deviation 6.20
|
1.50 score on scale
Standard Deviation 9.68
|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
-2.83 score on scale
Standard Deviation 6.11
|
-3.00 score on scale
Standard Deviation 9.90
|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
-5.00 score on scale
Standard Deviation 3.00
|
-13.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-1.00 score on scale
Standard Deviation 7.07
|
—
|
|
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
4.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Baseline
|
3.66 score on scale
Standard Deviation 1.61
|
3.92 score on scale
Standard Deviation 1.50
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24
|
-0.03 score on scale
Standard Deviation 0.38
|
-0.24 score on scale
Standard Deviation 0.71
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48
|
-0.06 score on scale
Standard Deviation 0.42
|
-0.32 score on scale
Standard Deviation 0.65
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72
|
0.21 score on scale
Standard Deviation 0.58
|
-0.29 score on scale
Standard Deviation 0.76
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96
|
-0.50 score on scale
Standard Deviation 0.76
|
-0.03 score on scale
Standard Deviation 0.48
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120
|
-0.50 score on scale
Standard Deviation 0.87
|
-0.22 score on scale
Standard Deviation 0.91
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144
|
-1.00 score on scale
Standard Deviation 0.71
|
0.18 score on scale
Standard Deviation 0.68
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168
|
-0.50 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.15 score on scale
Standard Deviation 1.13
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192
|
0.00 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.25 score on scale
Standard Deviation 1.06
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216
|
-0.50 score on scale
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Baseline: OD
|
0.560 LogMAR units
Standard Deviation 0.903
|
0.449 LogMAR units
Standard Deviation 0.712
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Baseline: OS
|
0.456 LogMAR units
Standard Deviation 0.811
|
0.545 LogMAR units
Standard Deviation 0.836
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 24: OD
|
-0.058 LogMAR units
Standard Deviation 0.512
|
0.039 LogMAR units
Standard Deviation 0.434
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 24: OS
|
0.046 LogMAR units
Standard Deviation 0.242
|
-0.001 LogMAR units
Standard Deviation 0.500
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 48: OD
|
-0.027 LogMAR units
Standard Deviation 0.097
|
0.053 LogMAR units
Standard Deviation 0.434
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 48: OS
|
0.050 LogMAR units
Standard Deviation 0.252
|
-0.006 LogMAR units
Standard Deviation 0.591
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 72: OD
|
-0.050 LogMAR units
Standard Deviation 0.140
|
-0.056 LogMAR units
Standard Deviation 0.260
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 72: OS
|
-0.083 LogMAR units
Standard Deviation 0.595
|
-0.101 LogMAR units
Standard Deviation 0.492
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 96: OD
|
-0.045 LogMAR units
Standard Deviation 0.099
|
-0.081 LogMAR units
Standard Deviation 0.580
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 96: OS
|
-0.260 LogMAR units
Standard Deviation 0.707
|
-0.121 LogMAR units
Standard Deviation 0.571
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 120: OS
|
0.000 LogMAR units
Standard Deviation 0.000
|
-0.229 LogMAR units
Standard Deviation 0.754
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 144: OD
|
0.010 LogMAR units
Standard Deviation 0.127
|
0.149 LogMAR units
Standard Deviation 0.618
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 144: OS
|
0.000 LogMAR units
Standard Deviation 0.000
|
-0.280 LogMAR units
Standard Deviation 0.846
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 168: OD
|
-0.080 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.134 LogMAR units
Standard Deviation 0.663
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 192: OD
|
-0.180 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.110 LogMAR units
Standard Deviation 0.156
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 120: OD
|
-0.027 LogMAR units
Standard Deviation 0.142
|
-0.039 LogMAR units
Standard Deviation 0.637
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 168: OS
|
-0.100 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.320 LogMAR units
Standard Deviation 0.910
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 192: OS
|
0.080 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
-0.050 LogMAR units
Standard Deviation 0.071
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 216: OD
|
-0.180 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Change from Baseline at Week 216: OS
|
-0.100 LogMAR units
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 216Population: 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.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=29 Participants
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.
|
Satralizumab, Then Satralizumab
n=60 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Baseline: 100% CHART
|
44.3 letters
Standard Deviation 16.1
|
44.4 letters
Standard Deviation 16.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Baseline: 1.25% CHART
|
17.5 letters
Standard Deviation 15.7
|
14.9 letters
Standard Deviation 14.8
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24: 100% CHART
|
0.5 letters
Standard Deviation 7.1
|
2.0 letters
Standard Deviation 5.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24: 2.5% CHART
|
-2.8 letters
Standard Deviation 9.1
|
1.7 letters
Standard Deviation 7.1
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 24: 1.25% CHART
|
-4.2 letters
Standard Deviation 11.9
|
0.1 letters
Standard Deviation 7.5
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48: 100% CHART
|
-3.4 letters
Standard Deviation 8.7
|
1.3 letters
Standard Deviation 6.1
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48: 2.5% CHART
|
1.5 letters
Standard Deviation 6.1
|
4.0 letters
Standard Deviation 9.2
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Baseline: 2.5% CHART
|
24.6 letters
Standard Deviation 16.2
|
22.6 letters
Standard Deviation 15.6
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96: 100% CHART
|
3.3 letters
Standard Deviation 13.2
|
2.1 letters
Standard Deviation 12.4
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120: 2.5% CHART
|
3.7 letters
Standard Deviation 4.6
|
2.1 letters
Standard Deviation 7.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120: 1.25% CHART
|
-2.0 letters
Standard Deviation 5.0
|
1.6 letters
Standard Deviation 9.1
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144: 100% CHART
|
-3.5 letters
Standard Deviation 2.1
|
0.4 letters
Standard Deviation 7.7
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144: 2.5% CHART
|
17.5 letters
Standard Deviation 17.7
|
1.6 letters
Standard Deviation 12.0
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 144: 1.25% CHART
|
-7.0 letters
Standard Deviation 7.1
|
1.4 letters
Standard Deviation 12.2
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192: 2.5% CHART
|
-1.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
-1.0 letters
Standard Deviation 4.2
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192: 1.25% CHART
|
-8.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
-4.0 letters
Standard Deviation 7.1
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 48: 1.25% CHART
|
1.7 letters
Standard Deviation 11.3
|
4.1 letters
Standard Deviation 9.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72: 100% CHART
|
0.3 letters
Standard Deviation 5.9
|
2.8 letters
Standard Deviation 7.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72: 2.5% CHART
|
-0.6 letters
Standard Deviation 8.6
|
2.6 letters
Standard Deviation 7.5
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 72: 1.25% CHART
|
-2.4 letters
Standard Deviation 8.3
|
0.4 letters
Standard Deviation 10.6
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96: 2.5% CHART
|
2.6 letters
Standard Deviation 20.1
|
2.3 letters
Standard Deviation 10.8
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 96: 1.25% CHART
|
-3.4 letters
Standard Deviation 11.3
|
-0.5 letters
Standard Deviation 11.3
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 120: 100% CHART
|
-1.0 letters
Standard Deviation 1.0
|
1.5 letters
Standard Deviation 10.6
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168: 100% CHART
|
—
|
2.1 letters
Standard Deviation 6.7
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168: 2.5% CHART
|
—
|
6.2 letters
Standard Deviation 8.2
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 168: 1.25% CHART
|
—
|
0.3 letters
Standard Deviation 12.2
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 192: 100% CHART
|
1.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
-2.5 letters
Standard Deviation 3.5
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216: 100% CHART
|
0.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216: 2.5% CHART
|
-1.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Change from Baseline at Week 216: 1.25% CHART
|
-8.0 letters
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Up to Week 216Population: The Safety Analysis Population (SAF) included all randomized participants who had received at least 1 dose of satralizumab or placebo.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Number of Participants With at Least One Adverse Event in the DB Period
|
24 participants
|
58 participants
|
SECONDARY outcome
Timeframe: Up to Week 216Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Number of Participants With at Least One Serious Adverse Event in the DB Period
|
5 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Up to Week 216Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Week 216Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
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).
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Number of Participants With Selected Adverse Events in the DB Period
Potential Opportunistic Infections
|
5 participants
|
3 participants
|
|
Number of Participants With Selected Adverse Events in the DB Period
Injection-related Reactions
|
5 participants
|
8 participants
|
|
Number of Participants With Selected Adverse Events in the DB Period
All Infections
|
14 participants
|
34 participants
|
|
Number of Participants With Selected Adverse Events in the DB Period
Serious Infections
|
3 participants
|
6 participants
|
|
Number of Participants With Selected Adverse Events in the DB Period
Psychiatric Disorders
|
4 participants
|
13 participants
|
|
Number of Participants With Selected Adverse Events in the DB Period
Anaphylaxis
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Post-Baseline (up to Week 216)Population: The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
Baseline
|
0 participants
|
9 participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
Post-Baseline
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204Population: 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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=62 Participants
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.
|
Satralizumab, Then Satralizumab
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Serum Satralizumab Concentration During the DB Period
Week 44
|
16110.00 ng/mL
Standard Deviation 15363.29
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 48
|
16701.16 ng/mL
Standard Deviation 16790.77
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 52
|
15300.57 ng/mL
Standard Deviation 14701.05
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 56
|
16390.82 ng/mL
Standard Deviation 16130.69
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 60
|
16050.81 ng/mL
Standard Deviation 14779.35
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 64
|
14385.10 ng/mL
Standard Deviation 14084.24
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 68
|
14010.46 ng/mL
Standard Deviation 13614.03
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 72
|
12895.69 ng/mL
Standard Deviation 13849.12
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 76
|
14139.31 ng/mL
Standard Deviation 14549.71
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 80
|
12709.79 ng/mL
Standard Deviation 14098.26
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 84
|
11725.05 ng/mL
Standard Deviation 13654.04
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 88
|
13733.17 ng/mL
Standard Deviation 13438.07
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 92
|
12928.13 ng/mL
Standard Deviation 13302.53
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Baseline
|
145.13 ng/mL
Standard Deviation 274.87
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 2
|
8099.70 ng/mL
Standard Deviation 4541.66
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 4
|
14602.50 ng/mL
Standard Deviation 8931.85
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 5
|
22564.32 ng/mL
Standard Deviation 12306.09
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 6
|
20991.43 ng/mL
Standard Deviation 12515.82
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 8
|
14864.35 ng/mL
Standard Deviation 9955.41
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 12
|
14760.33 ng/mL
Standard Deviation 10695.11
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 16
|
14613.11 ng/mL
Standard Deviation 11276.95
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 20
|
14136.62 ng/mL
Standard Deviation 12489.83
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 24
|
15634.18 ng/mL
Standard Deviation 13310.22
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 28
|
15538.38 ng/mL
Standard Deviation 13406.73
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 32
|
15111.94 ng/mL
Standard Deviation 13827.06
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 36
|
16068.58 ng/mL
Standard Deviation 14643.61
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 40
|
15428.04 ng/mL
Standard Deviation 16059.35
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 96
|
14036.58 ng/mL
Standard Deviation 12644.16
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 100
|
14186.50 ng/mL
Standard Deviation 12888.23
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 104
|
16647.00 ng/mL
Standard Deviation 15568.61
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 108
|
15970.00 ng/mL
Standard Deviation 13525.53
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 112
|
18657.37 ng/mL
Standard Deviation 17426.82
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 116
|
17677.33 ng/mL
Standard Deviation 16892.59
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 120
|
16615.00 ng/mL
Standard Deviation 16751.13
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 124
|
13734.00 ng/mL
Standard Deviation 12687.75
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 128
|
13738.00 ng/mL
Standard Deviation 16005.33
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 132
|
13311.73 ng/mL
Standard Deviation 15401.04
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 136
|
14208.54 ng/mL
Standard Deviation 15266.48
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 140
|
13404.62 ng/mL
Standard Deviation 12392.48
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 144
|
16138.18 ng/mL
Standard Deviation 13782.26
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 148
|
14044.33 ng/mL
Standard Deviation 12082.37
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 152
|
14644.42 ng/mL
Standard Deviation 13123.67
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 156
|
18856.36 ng/mL
Standard Deviation 20378.31
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 160
|
15238.18 ng/mL
Standard Deviation 11360.62
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 164
|
14760.00 ng/mL
Standard Deviation 11479.99
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 168
|
14199.60 ng/mL
Standard Deviation 9911.22
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 172
|
17971.43 ng/mL
Standard Deviation 16962.78
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 176
|
17922.86 ng/mL
Standard Deviation 12815.57
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 180
|
15981.43 ng/mL
Standard Deviation 9640.78
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 184
|
17911.67 ng/mL
Standard Deviation 15142.19
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 188
|
16442.50 ng/mL
Standard Deviation 13180.44
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 192
|
28750.00 ng/mL
Standard Deviation 22415.28
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 196
|
26850.00 ng/mL
Standard Deviation 20152.54
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 200
|
45000.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum Satralizumab Concentration During the DB Period
Week 204
|
34500.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216Population: 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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=30 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 116
|
1.57 pg/mL
Standard Deviation 0.00
|
31.73 pg/mL
Standard Deviation 23.27
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 120
|
1.57 pg/mL
Standard Deviation 0.00
|
55.92 pg/mL
Standard Deviation 68.46
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 124
|
1.57 pg/mL
Standard Deviation 0.00
|
29.46 pg/mL
Standard Deviation 19.49
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 128
|
1.57 pg/mL
Standard Deviation 0.00
|
31.20 pg/mL
Standard Deviation 21.29
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 132
|
1.57 pg/mL
Standard Deviation 0.00
|
33.84 pg/mL
Standard Deviation 34.36
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 164
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
34.00 pg/mL
Standard Deviation 24.13
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 168
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
26.29 pg/mL
Standard Deviation 20.85
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 172
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
23.57 pg/mL
Standard Deviation 6.59
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 176
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
27.73 pg/mL
Standard Deviation 11.10
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 184
|
3.63 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
17.34 pg/mL
Standard Deviation 8.47
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 188
|
5.21 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
17.78 pg/mL
Standard Deviation 7.22
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 192
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
16.55 pg/mL
Standard Deviation 3.89
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Baseline
|
3.66 pg/mL
Standard Deviation 6.49
|
3.49 pg/mL
Standard Deviation 5.14
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 2
|
5.90 pg/mL
Standard Deviation 16.31
|
30.14 pg/mL
Standard Deviation 26.07
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 4
|
5.41 pg/mL
Standard Deviation 10.02
|
51.53 pg/mL
Standard Deviation 126.49
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 8
|
3.30 pg/mL
Standard Deviation 4.59
|
30.88 pg/mL
Standard Deviation 25.57
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 12
|
3.40 pg/mL
Standard Deviation 4.21
|
32.02 pg/mL
Standard Deviation 24.91
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 16
|
3.72 pg/mL
Standard Deviation 4.54
|
28.59 pg/mL
Standard Deviation 23.27
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 20
|
2.99 pg/mL
Standard Deviation 2.88
|
24.06 pg/mL
Standard Deviation 19.59
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 24
|
3.68 pg/mL
Standard Deviation 4.02
|
26.27 pg/mL
Standard Deviation 23.19
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 28
|
3.88 pg/mL
Standard Deviation 4.24
|
26.89 pg/mL
Standard Deviation 24.01
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 32
|
3.43 pg/mL
Standard Deviation 3.20
|
33.29 pg/mL
Standard Deviation 37.93
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 36
|
3.78 pg/mL
Standard Deviation 3.65
|
26.03 pg/mL
Standard Deviation 21.75
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 40
|
4.82 pg/mL
Standard Deviation 6.45
|
24.16 pg/mL
Standard Deviation 19.93
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 44
|
3.47 pg/mL
Standard Deviation 3.65
|
26.16 pg/mL
Standard Deviation 20.39
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 48
|
4.58 pg/mL
Standard Deviation 4.21
|
29.61 pg/mL
Standard Deviation 27.37
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 52
|
3.52 pg/mL
Standard Deviation 3.36
|
26.94 pg/mL
Standard Deviation 22.26
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 56
|
4.13 pg/mL
Standard Deviation 5.26
|
33.15 pg/mL
Standard Deviation 40.66
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 60
|
3.28 pg/mL
Standard Deviation 3.65
|
31.34 pg/mL
Standard Deviation 25.38
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 64
|
4.08 pg/mL
Standard Deviation 4.48
|
30.60 pg/mL
Standard Deviation 24.55
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 68
|
2.75 pg/mL
Standard Deviation 3.35
|
30.56 pg/mL
Standard Deviation 44.67
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 72
|
2.95 pg/mL
Standard Deviation 4.80
|
23.16 pg/mL
Standard Deviation 17.54
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 76
|
2.44 pg/mL
Standard Deviation 3.04
|
24.08 pg/mL
Standard Deviation 16.78
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 80
|
1.57 pg/mL
Standard Deviation 0.00
|
24.86 pg/mL
Standard Deviation 17.89
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 84
|
2.27 pg/mL
Standard Deviation 1.84
|
27.61 pg/mL
Standard Deviation 23.04
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 88
|
1.57 pg/mL
Standard Deviation 0.00
|
26.51 pg/mL
Standard Deviation 20.07
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 92
|
3.38 pg/mL
Standard Deviation 4.80
|
25.48 pg/mL
Standard Deviation 17.24
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 96
|
1.57 pg/mL
Standard Deviation 0.00
|
24.57 pg/mL
Standard Deviation 15.25
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 100
|
1.57 pg/mL
Standard Deviation 0.00
|
26.31 pg/mL
Standard Deviation 18.74
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 104
|
1.57 pg/mL
Standard Deviation 0.00
|
26.30 pg/mL
Standard Deviation 19.96
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 108
|
1.57 pg/mL
Standard Deviation 0.00
|
27.64 pg/mL
Standard Deviation 23.97
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 112
|
1.57 pg/mL
Standard Deviation 0.00
|
27.39 pg/mL
Standard Deviation 22.72
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 136
|
1.57 pg/mL
Standard Deviation 0.00
|
51.83 pg/mL
Standard Deviation 73.68
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 140
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
41.00 pg/mL
Standard Deviation 45.44
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 144
|
1.57 pg/mL
Standard Deviation 0.00
|
28.26 pg/mL
Standard Deviation 25.64
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 148
|
1.57 pg/mL
Standard Deviation 0.00
|
28.76 pg/mL
Standard Deviation 21.52
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 152
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
28.07 pg/mL
Standard Deviation 23.66
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 156
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
27.25 pg/mL
Standard Deviation 19.19
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 160
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
29.60 pg/mL
Standard Deviation 20.30
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 180
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
24.09 pg/mL
Standard Deviation 9.21
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 196
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
14.45 pg/mL
Standard Deviation 2.76
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 200
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
36.90 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 204
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
12.30 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 208
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 212
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Week 216
|
1.57 pg/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216Population: 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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=62 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Baseline
|
31.88 ng/mL
Standard Deviation 7.50
|
33.18 ng/mL
Standard Deviation 7.72
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 2
|
32.72 ng/mL
Standard Deviation 8.09
|
396.49 ng/mL
Standard Deviation 80.09
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 4
|
44.79 ng/mL
Standard Deviation 64.73
|
509.21 ng/mL
Standard Deviation 121.99
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 8
|
33.23 ng/mL
Standard Deviation 7.21
|
560.63 ng/mL
Standard Deviation 164.11
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 12
|
33.02 ng/mL
Standard Deviation 7.65
|
582.36 ng/mL
Standard Deviation 169.71
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 16
|
31.60 ng/mL
Standard Deviation 8.18
|
582.22 ng/mL
Standard Deviation 204.20
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 20
|
32.99 ng/mL
Standard Deviation 8.14
|
555.64 ng/mL
Standard Deviation 210.76
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 24
|
32.47 ng/mL
Standard Deviation 8.69
|
573.01 ng/mL
Standard Deviation 217.93
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 28
|
31.83 ng/mL
Standard Deviation 9.71
|
565.29 ng/mL
Standard Deviation 219.88
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 32
|
33.33 ng/mL
Standard Deviation 9.97
|
564.13 ng/mL
Standard Deviation 215.59
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 36
|
34.03 ng/mL
Standard Deviation 7.79
|
572.31 ng/mL
Standard Deviation 207.35
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 40
|
33.64 ng/mL
Standard Deviation 9.44
|
554.90 ng/mL
Standard Deviation 241.34
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 44
|
33.97 ng/mL
Standard Deviation 9.05
|
585.62 ng/mL
Standard Deviation 219.45
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 48
|
33.72 ng/mL
Standard Deviation 8.18
|
591.06 ng/mL
Standard Deviation 213.04
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 52
|
33.47 ng/mL
Standard Deviation 7.58
|
575.56 ng/mL
Standard Deviation 210.84
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 56
|
30.34 ng/mL
Standard Deviation 5.21
|
585.40 ng/mL
Standard Deviation 233.38
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 60
|
30.58 ng/mL
Standard Deviation 6.81
|
586.40 ng/mL
Standard Deviation 226.21
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 64
|
32.27 ng/mL
Standard Deviation 7.63
|
602.72 ng/mL
Standard Deviation 239.25
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 68
|
31.19 ng/mL
Standard Deviation 7.23
|
617.80 ng/mL
Standard Deviation 244.63
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 72
|
31.12 ng/mL
Standard Deviation 7.76
|
543.95 ng/mL
Standard Deviation 224.00
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 76
|
30.56 ng/mL
Standard Deviation 7.06
|
558.67 ng/mL
Standard Deviation 234.41
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 80
|
33.36 ng/mL
Standard Deviation 9.91
|
558.73 ng/mL
Standard Deviation 235.60
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 84
|
30.95 ng/mL
Standard Deviation 8.96
|
552.37 ng/mL
Standard Deviation 226.76
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 88
|
32.05 ng/mL
Standard Deviation 7.23
|
547.93 ng/mL
Standard Deviation 211.74
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 92
|
28.93 ng/mL
Standard Deviation 5.72
|
580.64 ng/mL
Standard Deviation 201.78
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 96
|
32.88 ng/mL
Standard Deviation 5.62
|
561.64 ng/mL
Standard Deviation 205.00
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 100
|
31.84 ng/mL
Standard Deviation 7.62
|
559.18 ng/mL
Standard Deviation 194.43
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 104
|
31.70 ng/mL
Standard Deviation 8.81
|
598.05 ng/mL
Standard Deviation 192.99
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 108
|
30.55 ng/mL
Standard Deviation 6.94
|
592.06 ng/mL
Standard Deviation 193.20
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 112
|
29.93 ng/mL
Standard Deviation 8.47
|
603.31 ng/mL
Standard Deviation 227.68
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 116
|
34.30 ng/mL
Standard Deviation 13.37
|
609.37 ng/mL
Standard Deviation 198.61
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 120
|
38.20 ng/mL
Standard Deviation 10.96
|
625.15 ng/mL
Standard Deviation 229.67
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 124
|
37.87 ng/mL
Standard Deviation 13.59
|
580.07 ng/mL
Standard Deviation 240.15
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 128
|
44.50 ng/mL
Standard Deviation 2.40
|
574.54 ng/mL
Standard Deviation 214.94
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 132
|
29.80 ng/mL
Standard Deviation 8.63
|
575.40 ng/mL
Standard Deviation 213.45
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 136
|
29.45 ng/mL
Standard Deviation 11.53
|
593.92 ng/mL
Standard Deviation 209.84
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 140
|
37.20 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
627.32 ng/mL
Standard Deviation 232.08
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 144
|
31.10 ng/mL
Standard Deviation 10.18
|
693.82 ng/mL
Standard Deviation 239.70
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 148
|
28.55 ng/mL
Standard Deviation 13.08
|
690.83 ng/mL
Standard Deviation 142.94
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 152
|
33.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
626.41 ng/mL
Standard Deviation 229.59
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 156
|
39.90 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
682.82 ng/mL
Standard Deviation 156.88
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 160
|
45.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
694.18 ng/mL
Standard Deviation 127.92
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 164
|
43.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
696.18 ng/mL
Standard Deviation 106.76
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 168
|
40.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
681.00 ng/mL
Standard Deviation 122.60
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 172
|
49.70 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
672.71 ng/mL
Standard Deviation 107.83
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 176
|
45.50 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
700.71 ng/mL
Standard Deviation 90.64
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 180
|
55.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
702.00 ng/mL
Standard Deviation 75.60
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 184
|
41.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
678.33 ng/mL
Standard Deviation 78.20
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 188
|
40.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
688.75 ng/mL
Standard Deviation 143.82
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 192
|
43.40 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
668.00 ng/mL
Standard Deviation 192.33
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 196
|
38.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
630.00 ng/mL
Standard Deviation 141.42
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 200
|
35.80 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
815.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 204
|
33.70 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
783.00 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 208
|
35.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 212
|
30.50 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Week 216
|
37.60 ng/mL
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216Population: 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.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=32 Participants
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.
|
Satralizumab, Then Satralizumab
n=63 Participants
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 4
|
3.45 mg/L
Standard Deviation 6.24
|
0.82 mg/L
Standard Deviation 1.64
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 8
|
4.56 mg/L
Standard Deviation 8.97
|
0.83 mg/L
Standard Deviation 1.99
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 12
|
4.23 mg/L
Standard Deviation 7.23
|
1.23 mg/L
Standard Deviation 3.19
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 16
|
5.30 mg/L
Standard Deviation 9.17
|
1.56 mg/L
Standard Deviation 4.53
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 40
|
6.77 mg/L
Standard Deviation 10.92
|
2.55 mg/L
Standard Deviation 5.53
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 44
|
5.44 mg/L
Standard Deviation 8.72
|
3.31 mg/L
Standard Deviation 11.31
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 48
|
4.70 mg/L
Standard Deviation 5.43
|
1.79 mg/L
Standard Deviation 3.24
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 52
|
3.82 mg/L
Standard Deviation 4.75
|
1.90 mg/L
Standard Deviation 3.69
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 56
|
5.33 mg/L
Standard Deviation 8.87
|
2.32 mg/L
Standard Deviation 5.44
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 60
|
4.54 mg/L
Standard Deviation 5.60
|
3.20 mg/L
Standard Deviation 11.86
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 64
|
3.76 mg/L
Standard Deviation 4.62
|
1.92 mg/L
Standard Deviation 3.55
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 68
|
3.30 mg/L
Standard Deviation 5.11
|
3.65 mg/L
Standard Deviation 8.52
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 72
|
5.07 mg/L
Standard Deviation 11.87
|
3.33 mg/L
Standard Deviation 7.30
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 96
|
1.76 mg/L
Standard Deviation 2.47
|
1.64 mg/L
Standard Deviation 3.37
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 144
|
2.65 mg/L
Standard Deviation 2.19
|
0.96 mg/L
Standard Deviation 1.75
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 204
|
—
|
0.15 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 208
|
1.00 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 212
|
1.60 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 216
|
1.10 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
—
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Baseline
|
3.08 mg/L
Standard Deviation 3.77
|
4.95 mg/L
Standard Deviation 8.67
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 2
|
3.51 mg/L
Standard Deviation 4.55
|
0.93 mg/L
Standard Deviation 2.35
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 20
|
4.07 mg/L
Standard Deviation 5.20
|
1.78 mg/L
Standard Deviation 3.72
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 24
|
3.53 mg/L
Standard Deviation 4.08
|
1.72 mg/L
Standard Deviation 4.05
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 28
|
5.85 mg/L
Standard Deviation 9.99
|
2.35 mg/L
Standard Deviation 5.61
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 32
|
3.97 mg/L
Standard Deviation 5.20
|
2.06 mg/L
Standard Deviation 4.28
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 36
|
3.77 mg/L
Standard Deviation 4.40
|
1.56 mg/L
Standard Deviation 3.36
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 76
|
1.98 mg/L
Standard Deviation 2.12
|
2.79 mg/L
Standard Deviation 6.54
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 80
|
1.10 mg/L
Standard Deviation 0.72
|
2.83 mg/L
Standard Deviation 7.09
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 84
|
2.31 mg/L
Standard Deviation 4.66
|
3.81 mg/L
Standard Deviation 10.18
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 88
|
1.94 mg/L
Standard Deviation 3.38
|
2.64 mg/L
Standard Deviation 6.56
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 92
|
4.49 mg/L
Standard Deviation 10.18
|
1.94 mg/L
Standard Deviation 4.11
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 100
|
0.90 mg/L
Standard Deviation 0.87
|
1.87 mg/L
Standard Deviation 4.28
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 104
|
1.13 mg/L
Standard Deviation 1.01
|
1.93 mg/L
Standard Deviation 4.43
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 108
|
2.20 mg/L
Standard Deviation 3.16
|
2.56 mg/L
Standard Deviation 7.40
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 112
|
2.25 mg/L
Standard Deviation 2.68
|
1.53 mg/L
Standard Deviation 2.86
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 116
|
2.28 mg/L
Standard Deviation 3.41
|
1.19 mg/L
Standard Deviation 1.93
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 120
|
1.55 mg/L
Standard Deviation 1.63
|
6.05 mg/L
Standard Deviation 14.33
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 124
|
1.50 mg/L
Standard Deviation 1.04
|
3.24 mg/L
Standard Deviation 8.32
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 128
|
0.65 mg/L
Standard Deviation 0.64
|
3.09 mg/L
Standard Deviation 7.52
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 132
|
2.55 mg/L
Standard Deviation 1.77
|
2.66 mg/L
Standard Deviation 5.04
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 136
|
2.70 mg/L
Standard Deviation 1.27
|
2.85 mg/L
Standard Deviation 7.29
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 140
|
2.50 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
4.54 mg/L
Standard Deviation 9.57
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 148
|
4.80 mg/L
Standard Deviation 0.99
|
0.87 mg/L
Standard Deviation 1.44
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 152
|
1.20 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.79 mg/L
Standard Deviation 0.79
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 156
|
1.80 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.71 mg/L
Standard Deviation 1.17
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 160
|
1.20 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.82 mg/L
Standard Deviation 1.36
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 164
|
1.30 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.54 mg/L
Standard Deviation 0.50
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 168
|
1.30 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.37 mg/L
Standard Deviation 0.22
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 172
|
1.30 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.19 mg/L
Standard Deviation 0.09
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 176
|
1.30 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.25 mg/L
Standard Deviation 0.17
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 180
|
1.20 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.27 mg/L
Standard Deviation 0.16
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 184
|
1.10 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.22 mg/L
Standard Deviation 0.11
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 188
|
2.40 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.21 mg/L
Standard Deviation 0.13
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 192
|
1.10 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.33 mg/L
Standard Deviation 0.25
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 196
|
2.00 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.15 mg/L
Standard Deviation 0.00
|
|
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Week 200
|
1.10 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
0.50 mg/L
Standard Deviation NA
SD was not calculable for 1 participant.
|
SECONDARY outcome
Timeframe: Up to approximately Week 216Population: 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.
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.
Outcome measures
| Measure |
Placebo, Then Satralizumab
n=63 Participants
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.
|
Satralizumab, Then Satralizumab
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period
|
71.4 percentage of participants
|
—
|
Adverse Events
Placebo Double Blind Period
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
SA237 Double Blind Period
Serious events: 12 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo Open Label Period
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
SA237 Open Label Period
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Double Blind Period
n=32 participants at risk
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period.
|
SA237 Double Blind Period
n=63 participants at risk
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period.
|
Placebo Open Label Period
n=28 participants at risk
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. 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).
|
SA237 Open Label Period
n=56 participants at risk
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. 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).
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Eye disorders
Visual impairment
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Cystitis
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Cervical radiculopathy
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Hypothermia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Migraine
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Neuromyelitis optica pseudo relapse
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
Other adverse events
| Measure |
Placebo Double Blind Period
n=32 participants at risk
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period.
|
SA237 Double Blind Period
n=63 participants at risk
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. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period.
|
Placebo Open Label Period
n=28 participants at risk
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. 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).
|
SA237 Open Label Period
n=56 participants at risk
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. 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).
|
|---|---|---|---|---|
|
Infections and infestations
Otitis media
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 10 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Eye disorders
Vision blurred
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
6/56 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.9%
5/63 • Number of events 19 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.5%
11/63 • Number of events 15 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Influenza
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
14.3%
4/28 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
14.3%
9/63 • Number of events 11 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.9%
5/28 • Number of events 8 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
6/56 • Number of events 8 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Tooth abscess
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
6/32 • Number of events 14 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
15.9%
10/63 • Number of events 20 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
28.6%
8/28 • Number of events 19 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.9%
10/56 • Number of events 32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
8/32 • Number of events 23 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.5%
11/63 • Number of events 36 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.9%
5/28 • Number of events 8 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
17.9%
10/56 • Number of events 23 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 10 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 9 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Lymphocyte count decreased
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Neutrophil count decreased
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.9%
5/63 • Number of events 9 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 10 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
22.2%
14/63 • Number of events 14 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
6/56 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 7 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
6.3%
4/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
3/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
14.3%
9/63 • Number of events 12 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
12.5%
7/56 • Number of events 11 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Balance disorder
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
8.9%
5/56 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
15.9%
10/63 • Number of events 13 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
14.3%
4/28 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
14.3%
8/56 • Number of events 12 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.9%
5/63 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
9.5%
6/63 • Number of events 10 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
9.5%
6/63 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.4%
3/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
11.1%
7/63 • Number of events 9 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
15.9%
10/63 • Number of events 16 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Ear and labyrinth disorders
Ear pain
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Cystitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
10.7%
3/28 • Number of events 4 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
4/56 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Blood potassium increased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Complement factor decreased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
8.9%
5/56 • Number of events 10 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
International normalised ratio increased
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Low density lipoprotein increased
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 6 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 14 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
11.1%
7/63 • Number of events 9 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Influenza like illness
|
3.1%
1/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 5 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
1/28 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 13 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Injection site erythema
|
6.2%
2/32 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Oedema peripheral
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
4.8%
3/63 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.6%
2/56 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
3.2%
2/63 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.2%
2/32 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/56 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Complement factor C4 decreased
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/63 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
7.1%
2/28 • Number of events 2 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.8%
1/56 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/32 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
1.6%
1/63 • Number of events 1 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
0.00%
0/28 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
5.4%
3/56 • Number of events 3 • Double Blind Period: Up to primary clinical cut-off date, 12 Oct 2018 (up to approximately 217 weeks) Open Label Period: Up to primary clinical cut-off date, 31-Jan-2022 (up to approximately 336 weeks)
The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER