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

Primary Purpose

Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Satralizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromyelitis Optica (NMO)

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following:

    1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging [MRI] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis [MS]; NMO-IgG seropositive status)
    2. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral
  2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening
  3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening
  4. Age 18 to 74 years, inclusive at the time of informed consent
  5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol

Exclusion Criteria:

  1. Clinical relapse onset (including first attack) within 30 days prior to baseline

    Exclusion Criteria Related to Previous or Concomitant Therapy:

  2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
  3. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline
  4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline
  5. Treatment with any investigational agent within 3 months prior to baseline

    Exclusions for General Safety:

  6. Pregnancy or lactation.
  7. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug
  8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
  9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
  10. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
  11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline
  12. Evidence of chronic active hepatitis B or C
  13. History of drug or alcohol abuse within 1 year prior to baseline
  14. History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
  15. Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection)
  16. Evidence of active interstitial lung disease
  17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
  18. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured)
  19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions)
  20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
  21. History of Stevens-Johnson syndrome
  22. Following laboratory abnormalities at screening*.

    1. White blood cells <3.0 x10^3/microliter (μL)
    2. Absolute neutrophil count <2.0 x 10^3 /μL
    3. Absolute lymphocyte count <0.5 x 10^3 /μL
    4. Platelet count <10 x 10^4 /μL
    5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal.

      • If retest is conducted, the last value of retest before randomization must meet study criteria.

Sites / Locations

  • University of Colorado Denver -; Neurology
  • University of Miami UHealth Professional Arts Center
  • The MS Center of Vero Beach
  • Columbus Research and Wellness
  • University of Chicago; Neurology
  • Consultants in Neurology Ltd
  • OSF Saint Francis Medical Center
  • University of Kansas Medical Center
  • MidAmerica Neuroscience Institute
  • University of Michigan Health System
  • Wayne State University - Comp Clinic and MS. Center
  • University of North Carolina at Chapel Hill
  • The Neurological Institute PA
  • OhioHealth Research Institute
  • Thomas Jefferson University
  • University of Texas Southwestern Medical Center
  • Central Texas Neurology Consultants
  • UT Medicine San Antonio
  • Virginia Commonwealth University
  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
  • Medical Help Center EOOD
  • MMA-MHAT Pleven - Clinic for Neurology
  • UMHAT 'Dr. Georgi Stranski', EAD
  • MHATNP Sveti Naum EAD
  • UMHAT Alexandrovska, EAD
  • MS Clinical Trials Group
  • Recherche Sepmus Inc.
  • Centre hospitalier de l'Universite de Montreal (CHUM)
  • Klinicki bolnicki centar Osijek
  • LTD Helsicore
  • Pineo Medical Ecosystem LTD
  • S.Khechinashvili Tbilisi State Medical University Clinic Ne
  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  • Korea University Anam Hospital - Neurology
  • Seoul National University Hospital
  • Asan Medical Center
  • Severance Hospital - Yonsei University Health System - Neurology
  • Hospital Universiti Sains Malaysia [Neurology]
  • Hospital Kuala Lumpur
  • Philippine General Hospital
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
  • Miedzyleski Szpital Specjalistyczny w Warszawie
  • San Juan MS Center
  • SC Clubul Sanatatii SRL
  • China Medical University Healthcare System
  • National Cheng Kung University Hospital; Neurology
  • Taipei Veterans General Hospital-Neurology
  • Bilim University Medical Faculty Florence Nightingale Hospital
  • Ondokuz Mayis Univ. Med. Fac.
  • Ivano-Frankivska oblasna klinichna likarnia
  • Ivano-Frankivska miska klinichna likarnia №1
  • Kiev National Medical University
  • Municipal Foundation of Kyiv Regional Council " Kyiv Region
  • Reginal clinical psyconeurological hospital
  • Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr
  • Municipal Establishment "City Clinical Hospital #2; Neurology
  • Miska Klinichna Likarnia №16
  • KU "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Satralizumab

Placebo

Arm Description

Participants randomized to this arm for the double-blind period will receive satralizumab monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.

Participants randomized to this arm for the double-blind period will receive placebo monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized.. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.

Outcomes

Primary Outcome Measures

Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (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.

Secondary Outcome Measures

Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period
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).
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period
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.
Relapse-Free Rate During 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 onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse.
Annualized Relapse Rate (ARR) During the DB Period
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.
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
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
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
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.
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
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.
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
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.
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
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.
Number of Participants With at Least One Adverse Event in the DB Period
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.
Number of Participants With at Least One Serious Adverse Event in the DB Period
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.
Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period
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.
Number of Participants With Selected Adverse Events in the DB Period
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).
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
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.
Serum Satralizumab Concentration During the DB Period
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.

Full Information

First Posted
February 25, 2014
Last Updated
January 31, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02073279
Brief Title
Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Satralizumab
Arm Type
Experimental
Arm Description
Participants randomized to this arm for the double-blind period will receive satralizumab monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm for the double-blind period will receive placebo monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized.. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.
Intervention Type
Drug
Intervention Name(s)
Satralizumab
Other Intervention Name(s)
SA237, RG6168
Intervention Description
Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Primary Outcome Measure Information:
Title
Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period
Description
TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse.
Time Frame
Up to Week 216
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period
Description
The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = "no pain" and 100 = "pain as bad as it could be". Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the "no pain" marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE).
Time Frame
Baseline, Week 24
Title
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period
Description
The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement.
Time Frame
Baseline, Week 24
Title
Relapse-Free Rate During the DB Period
Description
Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse.
Time Frame
Up to Week 216
Title
Annualized Relapse Rate (ARR) During the DB Period
Description
The ARR is calculated as the total number of participants with adjudicated PDRs experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse.
Time Frame
Up to Week 216
Title
Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period
Description
The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period
Description
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement
Time Frame
Baseline up to Week 216
Title
Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period
Description
The T25W is an assessment of walking ability. The time (in seconds) that the participant took to walk 25 feet was measured. Speed is calculated as 1/Timed 25-Foot Walk where time is measured in seconds. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period
Description
The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period
Description
The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement.
Time Frame
Baseline up to Week 120
Title
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period
Description
The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period
Description
Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period
Description
The LCSLC evaluates the visual function and captures the minimum size at which individuals can perceive letters of a particular contrast level. The change in binocular visual acuity, as assessed by the number of letters read correctly from a distance of 2 meters on 100%, 2.5% and 1.25% contrast level Sloan letter charts, was analyzed. The LCSLC is scored on a scale of 0-60. Higher scores indicate better visual function. A positive change from baseline indicates an improvement.
Time Frame
Baseline up to Week 216
Title
Number of Participants With at Least One Adverse Event in the DB Period
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time Frame
Up to Week 216
Title
Number of Participants With at Least One Serious Adverse Event in the DB Period
Description
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame
Up to Week 216
Title
Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period
Description
Non-serious adverse events of special interest for this study included: 1) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment.
Time Frame
Up to Week 216
Title
Number of Participants With Selected Adverse Events in the DB Period
Description
Selected adverse events for this study included: 1) all infections, 2) serious infections, 3) potential opportunistic infections, 4) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), 5) psychiatric disorders and 6) anaphylaxis (an acute allergic/hypersensitivity reaction).
Time Frame
Up to Week 216
Title
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period
Description
The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior.
Time Frame
Baseline and Post-Baseline (up to Week 216)
Title
Serum Satralizumab Concentration During the DB Period
Time Frame
Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204
Title
Serum Interleukin-6 (IL-6) Concentration During the DB Period
Time Frame
Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Title
Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period
Time Frame
Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Title
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period
Time Frame
Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216
Title
Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period
Description
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.
Time Frame
Up to approximately Week 216

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following: NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging [MRI] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis [MS]; NMO-IgG seropositive status) NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening Age 18 to 74 years, inclusive at the time of informed consent Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Exclusion Criteria: Clinical relapse onset (including first attack) within 30 days prior to baseline Exclusion Criteria Related to Previous or Concomitant Therapy: Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline Treatment with any investigational agent within 3 months prior to baseline Exclusions for General Safety: Pregnancy or lactation. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML) Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline Evidence of chronic active hepatitis B or C History of drug or alcohol abuse within 1 year prior to baseline History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection) Evidence of active interstitial lung disease Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured) History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions) Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening History of Stevens-Johnson syndrome Following laboratory abnormalities at screening*. White blood cells <3.0 x10^3/microliter (μL) Absolute neutrophil count <2.0 x 10^3 /μL Absolute lymphocyte count <0.5 x 10^3 /μL Platelet count <10 x 10^4 /μL Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal. If retest is conducted, the last value of retest before randomization must meet study criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Denver -; Neurology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami UHealth Professional Arts Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The MS Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32962
Country
United States
Facility Name
Columbus Research and Wellness
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
University of Chicago; Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Consultants in Neurology Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
64637
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0666
Country
United States
Facility Name
Wayne State University - Comp Clinic and MS. Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Neurological Institute PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
UT Medicine San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219-1901
Country
United States
Facility Name
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical Help Center EOOD
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
MMA-MHAT Pleven - Clinic for Neurology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHATNP Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
UMHAT Alexandrovska, EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MS Clinical Trials Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Centre hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Klinicki bolnicki centar Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
LTD Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Pineo Medical Ecosystem LTD
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
S.Khechinashvili Tbilisi State Medical University Clinic Ne
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Korea University Anam Hospital - Neurology
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital - Yonsei University Health System - Neurology
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Hospital Universiti Sains Malaysia [Neurology]
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
San Juan MS Center
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
SC Clubul Sanatatii SRL
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
China Medical University Healthcare System
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital; Neurology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital-Neurology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Bilim University Medical Faculty Florence Nightingale Hospital
City
Istanbul
ZIP/Postal Code
34333
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Ivano-Frankivska oblasna klinichna likarnia
City
Ivano-Frankivsk
State/Province
KIEV Governorate
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivska miska klinichna likarnia №1
City
Ivano-Frankivsk
State/Province
KIEV Governorate
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Kiev National Medical University
City
Kiev
State/Province
KIEV Governorate
ZIP/Postal Code
3110
Country
Ukraine
Facility Name
Municipal Foundation of Kyiv Regional Council " Kyiv Region
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
4107
Country
Ukraine
Facility Name
Reginal clinical psyconeurological hospital
City
Ternopil
State/Province
KIEV Governorate
ZIP/Postal Code
46014
Country
Ukraine
Facility Name
Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr
City
Vinnytsya
State/Province
Poltava Governorate
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Establishment "City Clinical Hospital #2; Neurology
City
Zaporozhya
State/Province
Poltava Governorate
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
Miska Klinichna Likarnia №16
City
Dnipropetrovsk
State/Province
Tavria Okruha
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
KU "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
City
Odesa
State/Province
Tavria Okruha
ZIP/Postal Code
65006
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
36007339
Citation
Yamamura T, Weinshenker B, Yeaman MR, De Seze J, Patti F, Lobo P, von Budingen HC, Kou X, Weber K, Greenberg B. Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar. Mult Scler Relat Disord. 2022 Oct;66:104025. doi: 10.1016/j.msard.2022.104025. Epub 2022 Jul 5.
Results Reference
derived
PubMed Identifier
32333898
Citation
Traboulsee A, Greenberg BM, Bennett JL, Szczechowski L, Fox E, Shkrobot S, Yamamura T, Terada Y, Kawata Y, Wright P, Gianella-Borradori A, Garren H, Weinshenker BG. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020 May;19(5):402-412. doi: 10.1016/S1474-4422(20)30078-8.
Results Reference
derived

Learn more about this trial

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

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