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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04963270
Registration number
NCT04963270
Ethics application status
Date submitted
7/07/2021
Date registered
15/07/2021
Date last updated
28/02/2025
Titles & IDs
Public title
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
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Secondary ID [1]
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WN42636
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Generalized Myasthenia Gravis
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Satralizumab
Other interventions - Placebo
Experimental: Satralizumab - Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.
Placebo comparator: Placebo - Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
Treatment: Drugs: Satralizumab
Satralizumab will be administered as a subcutaneous injection
Other interventions: Placebo
Satralizumab placebo will be administered as a subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population
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Assessment method [1]
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The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [1]
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At Week 24
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Secondary outcome [1]
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DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24
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Assessment method [1]
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The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [1]
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At Week 24
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Secondary outcome [2]
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DB Period: Percentage of Participants With a = 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24
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Assessment method [2]
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The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.
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Timepoint [2]
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At Week 24
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Secondary outcome [3]
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DB Period: Percentage of Participants With a = 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24
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Assessment method [3]
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The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.
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Timepoint [3]
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At Week 24
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Secondary outcome [4]
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DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24
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Assessment method [4]
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The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
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Timepoint [4]
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At Week 24
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Secondary outcome [5]
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DB Period: Mean Change From Baseline in QMG Score in OP at Week 24
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Assessment method [5]
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The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
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Timepoint [5]
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At Week 24
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Secondary outcome [6]
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DB Period: Mean Change From Baseline in Myasthenia Gravis Quality of Life 15 Scale (Revised) (MG-QOL 15r) Total Score in AChR+ Population at Week 24
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Assessment method [6]
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The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items were scored on a scale from 0=Not at all to 2=Very much with the total score ranging from 0 to 30 and higher scores indicate worse health-related quality of life (HRQoL).
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Timepoint [6]
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At Week 24
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Secondary outcome [7]
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DB Period: Mean Change From Baseline in MG-QOL 15r Total Score in OP at Week 24
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Assessment method [7]
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The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items are scored on a scale from 0=Not at all to 2=Very much, with the total score ranging from 0 to 30 and higher scores indicate worse HRQoL.
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Timepoint [7]
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At Week 24
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Secondary outcome [8]
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DB Period: Mean Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale Total Score in AChR+ Population at Week 24
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Assessment method [8]
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The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.
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Timepoint [8]
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At Week 24
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Secondary outcome [9]
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DB Period: Mean Change From Baseline in Neuro-QoL Fatigue Subscale Total Score in OP at Week 24
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Assessment method [9]
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The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.
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Timepoint [9]
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At Week 24
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Secondary outcome [10]
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DB Period: Percentage of Participants With a = 3-point Reduction From Baseline in QMG Score in AChR+ Population at Week 24
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Assessment method [10]
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0
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
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Timepoint [10]
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At Week 24
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Secondary outcome [11]
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DB Period: Percentage of Participants With a = 3-point Reduction From Baseline in QMG Score in OP at Week 24
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Assessment method [11]
0
0
The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.
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Timepoint [11]
0
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At Week 24
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Secondary outcome [12]
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DB Period: Mean Change From Baseline in Total Myasthenia Gravis Composite (MGC) Score in AChR+ Population at Week 24
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Assessment method [12]
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The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
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Timepoint [12]
0
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At Week 24
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Secondary outcome [13]
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DB Period: Mean Change From Baseline in Total MGC Score in OP at Week 24
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Assessment method [13]
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0
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
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Timepoint [13]
0
0
At Week 24
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Secondary outcome [14]
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DB Period: Percentage of Participants With a = 3-point Reduction From Baseline in Total MGC Score in AChR+ Population at Week 24
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Assessment method [14]
0
0
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
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Timepoint [14]
0
0
At Week 24
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Secondary outcome [15]
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DB Period: Percentage of Participants With a = 3-point Reduction From Baseline in Total MGC Score in OP at Week 24
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Assessment method [15]
0
0
The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.
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Timepoint [15]
0
0
At Week 24
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Secondary outcome [16]
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DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in AChR+ Population at Week 24
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Assessment method [16]
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0
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [16]
0
0
At Week 24
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Secondary outcome [17]
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DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in OP at Week 24
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Assessment method [17]
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0
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [17]
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At Week 24
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Secondary outcome [18]
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DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in AChR+ Population
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Assessment method [18]
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gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.
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Timepoint [18]
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Baseline up to Week 24
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Secondary outcome [19]
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DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in OP
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Assessment method [19]
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gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.
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Timepoint [19]
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Baseline up to Week 24
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Secondary outcome [20]
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DB Period: Percentage of Participants in AChR+ Population Receiving Rescue Therapy Between Baseline and Week 24
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Assessment method [20]
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The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.
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Timepoint [20]
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Baseline up to Week 24
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Secondary outcome [21]
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DB Period: Percentage of Participants in OP Receiving Rescue Therapy Between Baseline and Week 24
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Assessment method [21]
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The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.
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Timepoint [21]
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0
Baseline up to Week 24
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Secondary outcome [22]
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DB Period: Duration of Meaningful Improvement, Defined as = 2-Point Reduction From Baseline in Total MG-ADL Score in AChR+ Population
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Assessment method [22]
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The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [22]
0
0
Baseline, Week 24
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Secondary outcome [23]
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DB Period: Duration of Meaningful Improvement, Defined as = 2-Point Reduction From Baseline in Total MG-ADL Score in OP
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Assessment method [23]
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The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.
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Timepoint [23]
0
0
Baseline, Week 24
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Secondary outcome [24]
0
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DB Period: Number of Participants With Adverse Events (AEs)
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Assessment method [24]
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An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptoms, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Timepoint [24]
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0
Day 1 up to approximately 24 weeks
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Secondary outcome [25]
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DB Period: Serum Levels of Interleukin-6 (IL-6)
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Assessment method [25]
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0
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Timepoint [25]
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0
Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [26]
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DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)
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Assessment method [26]
0
0
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Timepoint [26]
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0
Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
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Secondary outcome [27]
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Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab
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Assessment method [27]
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The percentage of ADA-positive participants after drug administration were determined for participants exposed to satralizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. Participants were considered to be ADA-negative if they were ADA-negative or had missing data at baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that is at least 4-fold (0.60 titer unit) greater than the titer of the baseline sample.
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Timepoint [27]
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0
Baseline to Week 24
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Secondary outcome [28]
0
0
Serum Concentrations of Satralizumab
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Assessment method [28]
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0
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Timepoint [28]
0
0
Weeks 0, 2, 4, 8, 12, 16, 20 and 24
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Eligibility
Key inclusion criteria
* Signed Informed Consent Form
* For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
* Ability to comply with the study protocol procedures
* Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
* A total MG-ADL score of = 5 points at screening with more than 50% of this score attributed to non-ocular items
* MGFA severity Class II-IV
* Ongoing gMG treatment at a stable dose
* For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of thymectomy within 12 months prior to screening
* Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
* Known disease other than gMG that would interfere with the course and conduct of the study
* Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
* Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/09/2024
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Sample size
Target
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Accrual to date
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Final
188
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
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Recruitment postcode(s) [1]
0
0
2139 - Concord
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
District of Columbia
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Caba
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Country [5]
0
0
Argentina
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State/province [5]
0
0
Ciudad Autonoma Bs As
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Mendoza
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Rosario
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Country [8]
0
0
Brazil
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State/province [8]
0
0
Rio Grande Do Sul
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Country [9]
0
0
Brazil
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State/province [9]
0
0
São Paulo
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Country [10]
0
0
Canada
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State/province [10]
0
0
Quebec
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Country [11]
0
0
China
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State/province [11]
0
0
Beijing
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Country [12]
0
0
China
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State/province [12]
0
0
Changchun City
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Country [13]
0
0
China
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State/province [13]
0
0
Chengdu City
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Country [14]
0
0
China
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State/province [14]
0
0
Guiyang
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Country [15]
0
0
China
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State/province [15]
0
0
Hangzhou
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Country [16]
0
0
China
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State/province [16]
0
0
Jinan
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Country [17]
0
0
China
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State/province [17]
0
0
Shanghai City
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Country [18]
0
0
China
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State/province [18]
0
0
Shanghai
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Country [19]
0
0
China
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China
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Samsun
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Chugai Pharmaceutical
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Ethics approval
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Summary
Brief summary
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
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Trial website
https://clinicaltrials.gov/study/NCT04963270
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Reference Study ID Number: GE42063 https://forpatients.roche.com/
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888-662-6728 (U.S.)
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/70/NCT04963270/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/70/NCT04963270/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04963270
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