Clinical Trial Results:
A Multicenter, Single Arm, Open-label Study to Evaluate the Long-term Safety and Efficacy of Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)
Summary
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EudraCT number |
2020-003413-35 |
Trial protocol |
GB DE HU BG PL IT HR |
Global end of trial date |
28 May 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Dec 2024
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First version publication date |
14 Dec 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
WN42349
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04660539 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4058
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Public contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Scientific contact |
F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 May 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 May 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The study aims to evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optic spectrum disorder (NMOSD). Study WN42349 is not a part of a PIP. However, the parent studies (2013-003752-21 and 2015-005431-41) were a part of a PIP, with an EMA-PIP number of EMEA-001625-PIP01-14.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
02 Mar 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 4
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Country: Number of subjects enrolled |
Canada: 10
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Country: Number of subjects enrolled |
Germany: 3
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Country: Number of subjects enrolled |
Spain: 3
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
United Kingdom: 2
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Country: Number of subjects enrolled |
Georgia: 1
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Country: Number of subjects enrolled |
Croatia: 1
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Country: Number of subjects enrolled |
Hungary: 2
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Country: Number of subjects enrolled |
Italy: 6
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Country: Number of subjects enrolled |
Japan: 20
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Country: Number of subjects enrolled |
Korea, Republic of: 5
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Country: Number of subjects enrolled |
Malaysia: 1
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Country: Number of subjects enrolled |
Poland: 30
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Country: Number of subjects enrolled |
Romania: 1
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Country: Number of subjects enrolled |
Türkiye: 1
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Country: Number of subjects enrolled |
Taiwan: 16
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Country: Number of subjects enrolled |
Ukraine: 12
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Country: Number of subjects enrolled |
United States: 47
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Worldwide total number of subjects |
166
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EEA total number of subjects |
51
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
8
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Adults (18-64 years) |
154
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 119 participants from studies BN40898 & BN40900 rolled over in study WN42349 at 53 sites in 17 countries. ‘All Participants-treated population’ is used to report results, which includes 166 participants who received at least one dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in WN42349. | ||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants from 2013-003752-21 and 2015-005431-41 enrolled in this study to receive satralizumab treatment. Participants were permitted to use azathioprine (AZA) or mycophenolate mofetil (MMF) or oral corticosteroids during the study as background immunosuppressive treatments. | ||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
Arms
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Arm title
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Satralizumab | ||||||||||||||||||||||||||
Arm description |
Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here. | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
Satralizumab
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Investigational medicinal product code |
RO5541267
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Satralizumab, 120 mg, as SC injection for up to 3 years.
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Baseline characteristics reporting groups
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Reporting group title |
Satralizumab
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Reporting group description |
Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Satralizumab
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Reporting group description |
Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 milligrams (mg) as subcutaneous (SC) injection, every 4 weeks (Q4W) up to a maximum duration of 3 years in the current study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in the current study are represented here. |
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End point title |
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1] | ||||||||||
End point description |
AE=any untoward medical occurrence in a participant administered a medicinal product, regardless of causal relationship with it. AE=unfavorable & unintended sign, symptoms/disease temporally associated with use of medicinal product, whether or not considered related to it. SAE=any significant hazard, contraindication/side effect that is fatal/ life-threatening, requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is congenital anomaly, is medically significant/requires intervention. First dosing visit in current study/randomization visit in the parent studies was considered as baseline. All AEs from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population=participants who received at least 1 dose of satralizumab at any time during parent or this study, irrespective of enrollment in current study.
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End point type |
Primary
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End point timeframe |
Baseline up to 523 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistics was planned for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Participants with Adverse Events of Special Interest (AESIs) and Selected AEs [2] | ||||||||||
End point description |
An AESIs included potential drug induced liver injury & suspected transmission of infectious agent by study drug defined as any organism, virus or infectious particle, pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate infection in participant exposed to medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals or antivirals and injection related reaction. First dosing visit in current study or randomization visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All AEs from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least 1 dose of satralizumab at any time during parent or this study.
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End point type |
Primary
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End point timeframe |
Baseline up to 523 weeks
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistics was planned for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of Participants with Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | ||||||||||||||||||||||||||||||||||||||
End point description |
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) and any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior and attempts with actual/potential lethality. Categories have 2 responses(yes/no) & include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) w/o Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, w/o Specific Plan; e-Active Suicidal Ideation with Specific Plan & Intent, f-Preparatory Acts & Behavior; g-Aborted Attempt; h-Interrupted Attempt; i-Actual Attempt(non-fatal); j-Completed Suicide. Suicidal ideation or behavior is indicated by yes answer to any categories. Score=0 if no suicide risk present. Score≥1=suicidal ideation or behavior. All Participants-treated population. Baseline=1st dosing visit in current study/randomization visit in parent studies.
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End point type |
Secondary
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End point timeframe |
Baseline up to 523 weeks
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No statistical analyses for this end point |
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End point title |
Number of Participants with Serious Infections and Hepatotoxicity | ||||||||||
End point description |
Hepatotoxicity was defined using the following Medical Dictionary for Regulatory Activities Standardised MedDRA Queries (MedDRA SMQs) - Cholestasis and jaundice of hepatic origin (SMQ narrow) and Drug related hepatic disorders - severe events only (SMQ narrow). The first dosing visit in the current study or randomization visit in the parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. Data for all serious infections and hepatotoxicity from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population=participants who received at least 1 dose of satralizumab at any time during parent or this study, irrespective of enrollment in WN42349 .
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End point type |
Secondary
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End point timeframe |
Baseline up to 523 weeks
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No statistical analyses for this end point |
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End point title |
Annualized Relapse Rate (ARR) | ||||||||
End point description |
ARR calculated as total number of relapses experienced divided by participant-years of whole study period. Adjusted AAR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to 1st occurrence of iPDR. PDR = occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New/worsening neurological symptoms occurring < 31 days following onset of PDR were considered part of same relapse. Time point of relapse onset=time at which participant experienced any new/worsening neurological symptoms representing NMOSD clinical relapse(s). Baseline was defined as first dosing visit in current study/randomization visit in parent studies (2013-003752-21/2015-005431-41). All ARR data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants is used for analysis.
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End point type |
Secondary
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End point timeframe |
Baseline up to 528 weeks
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No statistical analyses for this end point |
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End point title |
Percentage of Relapse-Free Participants | ||||||||
End point description |
Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur < 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All data from the time of randomization in the parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any relapse events are reported here. Percentages have been rounded off to the nearest decimal point. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study.
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End point type |
Secondary
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End point timeframe |
Baseline up to 528 weeks
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No statistical analyses for this end point |
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End point title |
iPDR-free Rate up to Week 456 | ||||||||
End point description |
iPDR free rate was defined as percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. PDR was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a PDR were considered part of the same relapse. First dosing visit in the current study or randomization visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this endpoint. All data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Percentages have been rounded off to the nearest decimal point. Kaplan-Meier method was used to estimate the iPDR-free rates. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 456
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No statistical analyses for this end point |
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End point title |
Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | ||||||||
End point description |
Time to first relapse (TFR) was defined as the time from randomization in parent studies to the first occurrence of the first iPDR. PDR=occurrence of new or worsening neurological symptoms attributable to NMO/NMOSD. New/worsening neurological symptoms occurring < 31 days following onset of PDR were considered part of same relapse. Time point of relapse onset=time at which participant experienced new/worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at clinical cutoff date (CCOD) or at withdrawal from study. Baseline=1st visit in current study/randomization visit in parent studies. TFR data from time of randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population. 99999=insufficient number of events to estimate median and 95% CI.
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End point type |
Secondary
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End point timeframe |
Baseline up to 528 weeks
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No statistical analyses for this end point |
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End point title |
Change in Expanded Disability Status Scale (EDSS) Score | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
EDSS=quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. Baseline=last observation on/before the day of first study drug administration in this study/parent studies (2013-003752-21/2015-005431-41). EDSS data from the time of randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Number analyzed=number of participants with data available for analysis. "n"= participants with data available for analysis at the specified timepoint. 99999=standard deviation (SD) was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline and every 24 weeks (up to 528 weeks)
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No statistical analyses for this end point |
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End point title |
Time to First EDSS Scores Worsening | ||||||||
End point description |
EDSS=quantitative measure with values from 0 points (normal neurological examination) to 10 points (death), increasing in increments of 0.5 points. EDSS worsening=(a) worsening of ≥2 points in EDSS score for participants with a baseline score (BS) of 0, (b) worsening of ≥1points in EDSS score for participants with a BS of 1-5, or (c) worsening of ≥0.5 points in EDSS score for participants with a BS of ≥5.5. Participants were censored at date of last EDSS assessment/if no assessment was performed at randomization. Baseline is the last observation on/before day of 1st drug administration in this study/parent studies (2013-003752-21/2015-005431-41). EDSS data from randomization in parent studies to end of this study for satralizumab-treated participants are reported. All Participants-treated population is used. Number analyzed=participants with data available for analysis. 99999=there was an insufficient number of events to estimate median & 95% CI.
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End point type |
Secondary
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End point timeframe |
Baseline up to 528 weeks
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No statistical analyses for this end point |
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End point title |
Percentage of Participants without EDSS Worsening | ||||||||
End point description |
EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with BS of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1-5, (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). EDSS data from time of randomization in parent studies up to end of study WN42349 for all participants are reported here. All Participants-treated population.Participants from parent studies who did not enroll in the current study are also considered for efficacy analysis. Number analyzed=participants with data available for analysis.
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End point type |
Secondary
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End point timeframe |
Baseline up to 528 weeks
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No statistical analyses for this end point |
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End point title |
Change in Visual Acuity (VA) Assessed by a Snellen 20-Foot Wall Chart | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
VA was measured using Snellen 20-foot wall chart & then converted to logMAR VA scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) & left eye (OS). Scores worse than 20/200 [i.e. CF (counting fingers), HM (hand movement), LP (light perception), or NLP (no LP)] are converted to logMAR 1.85, logMAR 2.00, logMAR 2.70 & logMAR 3.00. LogMAR >= 1 is equivalent to Physically blind. Negative change from baseline =improvement. Baseline=first dosing visit in current study/randomization visit in parent studies. VA data from time of randomization in parent studies to end of study WN42349 for satralizumab-treated participants are reported. All Participants-treated population=participants who received at least one dose of satralizumab any time during the parent studies or this study, irrespective of enrollment in WN42349. "n"=participants with data available for analysis at specified timepoint. 99999=SD was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline and every 24 weeks (up to 528 weeks)
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No statistical analyses for this end point |
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End point title |
Event-free Rate for EDSS Score Worsening up to Week 456 | ||||||||
End point description |
Event-free rate for EDSS score worsening=percentage of participants who did not experience worsening in their EDSS score from baseline. EDSS=quantitative measure of disability & for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. Participants were censored at the date of the last EDSS assessment or if no EDSS assessment was performed at the randomization date. Baseline=last observation on/before the day of first study drug administration in current study/parent studies (2013-003752-21/2015-005431-41). All EDSS data from the time of randomization in parent studies up to Week 456 for satralizumab-treated participants are reported here. Kaplan-Meier method was used to estimate the event-free rates. All Participants-treated population is used. Number analyzed is number of participants with data available for analysis.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 456
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No statistical analyses for this end point |
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End point title |
Concentrations of Interleukin-6 (IL-6) in Blood | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
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No statistical analyses for this end point |
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End point title |
Concentrations of Soluble IL-6 Receptor (sIL-6R) in Blood | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
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No statistical analyses for this end point |
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End point title |
Concentration of C-Reactive Protein (CRP) in Blood | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed=participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline, every two weeks from Weeks 2 to 8; every 4 weeks from Weeks 12 to 192; every 24 weeks from Weeks 216 to 528
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No statistical analyses for this end point |
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End point title |
Serum Concentration of Satralizumab at Specified Timepoints | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as last observation collected on or before day of first study drug administration in parent studies (2013-003752-21/2015-005431-41). All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. Number analyzed is the number of participants with data available for analysis. "n"=participants with data available for analysis at the specified timepoint. 99999=Geometric coefficient of variation was not evaluable as only 1 participant was analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 2, Week 4, Week 5, Week 6; every 4 weeks from Weeks 8 to 192; every 24 weeks from Weeks 216 to 528
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No statistical analyses for this end point |
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End point title |
Number of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies 2013-003752-21 and 2015-005431-41 | ||||||||||||||
End point description |
Number of ADA-positive participants & ADA-negative participants at baseline (baseline prevalence) & after drug administration (post-baseline incidence) were summarized. Baseline evaluable participants = participants with an ADA assay result at baseline. Post-baseline evaluable participants = participants with an ADA assay from at least one post-baseline sample. Participants positive for ADA= number of participants with positive ADA result. Participants negative for ADA=number of participants with negative or missing baseline ADA result(s) & all negative post-baseline results. Baseline = last observation collected on or before day of first study drug administration in parent studies. All data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. All Participants-treated population is used for analysis. 'n'=number of participants with data available for analysis at the specified timepoint.
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End point type |
Secondary
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End point timeframe |
First dose of satralizumab in parent studies up to 528 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 523 weeks
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Adverse event reporting additional description |
All Participants-treated population=all enrolled participants (in current study) who received at least 1 dose of satralizumab at any time either during parent studies or this study. First dosing visit in the current study or first satralizumab dosing visit in parent studies (2013-003752-21/2015-005431-41) was considered as baseline for this study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.0
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Reporting groups
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Reporting group title |
Satralizumab
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Reporting group description |
Participants rolled over from studies 2013-003752-21 and 2015-005431-41 received satralizumab, 120 mg as SC injection, Q4W up to a maximum duration of 3 years in this study. Participants who received at least 1 dose of satralizumab at any time during parent studies or this study, irrespective of enrollment in current study are represented here. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |