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Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO 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
Baseline Treatment
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

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

Inclusion Criteria:

  1. Patients 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 the following Wingerchuk 2007 criteria with anti-AQP4 antibody (Ab) seropositive status at screening (i. Idiopathic single or recurrent events of longitudinally extensive myelitis [≥3 vertebral segment spinal cord MRI lesion]; ii. Optic neuritis: recurrent or simultaneous bilateral); For patients aged 12 to 17 years, a minimum of 4 patients should be positive for anti-AQP4Ab status at screening
  2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening
  3. EDSS score from 0 to 6.5 inclusive at screening
  4. Age 12 to 74 years, inclusive at the time of informed consent
  5. One of the following baseline treatments must be at stable dose as a monotherapy for 8 weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids. For participants aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate mofetil + oral corticosteroids
  6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol

For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2 documented relapses (including first attack) prior to screening.

Exclusion Criteria:

Exclusion criteria related to previous or concomitant therapy:

  1. Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
  2. Any previous treatment with anti-CD20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline
  3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline
  4. Treatment with any investigational agent within 3 months prior to baseline

    Exclusions for general safety:

  5. Pregnancy or lactation
  6. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient 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
  7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
  8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
  9. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: 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
  10. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline
  11. Evidence of chronic active hepatitis B or C
  12. History of drug or alcohol abuse within 1 year prior to baseline
  13. History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
  14. Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection)
  15. Evidence of active interstitial lung disease
  16. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
  17. 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)
  18. History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic reactions)
  19. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
  20. Following laboratory abnormalities at screening*.

    1. White blood cells (WBC) <3.0 x10^3/microliter (μL)
    2. Absolute neutrophil count (ANC) <2.0 x10^3/μL
    3. Absolute lymphocyte count <0.5 x10^3/μL
    4. Platelet count <10 x 10^4/μL
    5. Aspartate aminotransferase (AST) or alanine aminotranferase (ALT) >1.5 times the upper limit of normal (ULN) * If retest is conducted, the last value of retest before randomization must meet study criteria.

For adolescents who may be enrolled after the end of the double-blind period, the annotation in the exclusion criterion 20 is as follows (other criteria are same): * If retest is conducted, the last value of retest before baseline must meet study criteria

Sites / Locations

  • Children's Hospital of Alabama
  • Hopital de Hautepierre CHRU de Strasbourg
  • NeuroCure Clinical Research Center (NCRC)
  • St. Josef-Hospital, Klinik für Neurologie
  • Heinrich-Heine Universitätsklinik Düsseldorf
  • Jahn Ferenc Dél-Pesti Kórház
  • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
  • Ospedale San Raffaele
  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  • Fond. Ist. S. Raffaele - giglio
  • Juntendo University Hospital; Neurology
  • Kyushu University Hospital; Neurology
  • Fukushima Medical University Hospital; Neurology
  • Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics
  • Niigata University Medical and Dental Hospital; Neurology
  • Kindai University Hospital; Neurology
  • Tohoku University Hospital; Neurology
  • Tokyo Women's Medical University Hospital; Neurology
  • Osaka University Hospital; Neurology
  • National Center of Neurology and Psychiatry
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
  • M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
  • Centrum Medyczne Dendryt
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
  • Instytut Psychiatrii i Neurologii
  • Samodzielny Publiczny Centralny Szpital Klinicznyi
  • Hospital Clinic de Barcelona
  • Hospital Clinico San Carlos; Servicio de Nefrologia
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology
  • China Medical University Hospital; Neurology - Taichung
  • National Cheng Kung University Hospital; Neurology
  • National Taiwan University Hospital; Neurology
  • Taipei Veterans General Hospital-Neurology
  • Kharkivska miska dytiacha likarnia # 5
  • KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
  • University Hospital of Wales; Dept of Neurology
  • John Radcliffe Hospital; Neurosciences
  • The National Hospital for Neurology & Neurosurgery
  • Great Ormond Street Hospital For Children; Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Satralizumab + Baseline Treatment

Placebo + Baseline Treatment

Arm Description

Participants randomized to this arm for the double-blind period will receive satralizumab in addition to baseline treatment. The double-blind period ends when either the participant has a treated relapse or the total number of protocol-defined relapses confirmed by the Clinical Endpoint Committee (CEC) reaches 26. In the open-label extension period, the participant will receive (with or without baseline treatment) an SC injection of satralizumab at Weeks 0, 2, and 4, and Q4W thereafter, with the last study drug administration on or before 31 December 2021.

Participants randomized to this arm for the double-blind period will receive placebo in addition to baseline treatment.The double-blind period ends when either the participant has a treated relapse or the total number of protocol-defined relapses confirmed by the Clinical Endpoint Committee (CEC) reaches 26. In the open-label extension period, the participant will receive (with or without baseline treatment) an SC injection of satralizumab at Weeks 0, 2, and 4, and Q4W thereafter, with the last study drug administration on or before 31 December 2021.

Outcomes

Primary Outcome Measures

Time to First Protocol-Defined Relapse (TFR) in the Double-Blind 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) as adjudicated by an independent clinical endpoint committee (CEC). 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 at Week 24 in the Visual Analogue Scale (VAS) Score 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 at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score 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. ANCOVA was used for analysis to report the adjusted mean and SE.
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 relapses 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 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 Short Form Generic Health Survey (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 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 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.
Serum Satralizumab 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
Serum Interleukin-6 (IL-6) Concentration During the DB Period
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) non-serious infections that required treatments with intravenous (IV) antibiotic, antifungal, antiviral, 2) opportunistic infections that required treatments with oral antibiotics, antifungals, or antivirals, 3) 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), and 4) 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.
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.
Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during Overall S237 period.

Full Information

First Posted
January 6, 2014
Last Updated
March 23, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02028884
Brief Title
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Official Title
A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2014 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
December 23, 2021 (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 objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment 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
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Satralizumab + Baseline Treatment
Arm Type
Experimental
Arm Description
Participants randomized to this arm for the double-blind period will receive satralizumab in addition to baseline treatment. The double-blind period ends when either the participant has a treated relapse or the total number of protocol-defined relapses confirmed by the Clinical Endpoint Committee (CEC) reaches 26. In the open-label extension period, the participant will receive (with or without baseline treatment) an SC injection of satralizumab at Weeks 0, 2, and 4, and Q4W thereafter, with the last study drug administration on or before 31 December 2021.
Arm Title
Placebo + Baseline Treatment
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm for the double-blind period will receive placebo in addition to baseline treatment.The double-blind period ends when either the participant has a treated relapse or the total number of protocol-defined relapses confirmed by the Clinical Endpoint Committee (CEC) reaches 26. In the open-label extension period, the participant will receive (with or without baseline treatment) an SC injection of satralizumab at Weeks 0, 2, and 4, and Q4W thereafter, with the last study drug administration on or before 31 December 2021.
Intervention Type
Drug
Intervention Name(s)
Satralizumab
Other Intervention Name(s)
SA237, RG6168, RO5333787
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).
Intervention Type
Drug
Intervention Name(s)
Baseline Treatment
Intervention Description
As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period.
Primary Outcome Measure Information:
Title
Time to First Protocol-Defined Relapse (TFR) in the Double-Blind 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) as adjudicated by an independent clinical endpoint committee (CEC). 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 224
Secondary Outcome Measure Information:
Title
Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score 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 at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score 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. ANCOVA was used for analysis to report the adjusted mean and SE.
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 relapses 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 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 168
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 Short Form Generic Health Survey (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 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 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
Serum Satralizumab Concentration During the DB Period
Time Frame
Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 224
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 224
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 224
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 224
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 224
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 224
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 224
Title
Number of Participants With Selected Adverse Events in the DB Period
Description
Selected adverse events for this study included: 1) non-serious infections that required treatments with intravenous (IV) antibiotic, antifungal, antiviral, 2) opportunistic infections that required treatments with oral antibiotics, antifungals, or antivirals, 3) 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), and 4) anaphylaxis (an acute allergic/hypersensitivity reaction).
Time Frame
Up to Week 224
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 224)
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 224
Title
Percentage of Participants With Anti-Drug Antibodies to Satralizumab Overall S237 Period
Description
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during Overall S237 period.
Time Frame
Up to approximately Week 368

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 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 the following Wingerchuk 2007 criteria with anti-AQP4 antibody (Ab) seropositive status at screening (i. Idiopathic single or recurrent events of longitudinally extensive myelitis [≥3 vertebral segment spinal cord MRI lesion]; ii. Optic neuritis: recurrent or simultaneous bilateral); For patients aged 12 to 17 years, a minimum of 4 patients should be positive for anti-AQP4Ab status at screening Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening EDSS score from 0 to 6.5 inclusive at screening Age 12 to 74 years, inclusive at the time of informed consent One of the following baseline treatments must be at stable dose as a monotherapy for 8 weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids. For participants aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate mofetil + oral corticosteroids Ability and willingness to provide written informed consent and to comply with the requirements of the protocol For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2 documented relapses (including first attack) prior to screening. Exclusion Criteria: Exclusion criteria related to previous or concomitant therapy: Any previous treatment with 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, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline Any previous treatment with anti-CD4, cladribine 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 patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient 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 patient participation, such as: 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 (TB; excluding patients receiving chemoprophylaxis for latent TB 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 Following laboratory abnormalities at screening*. White blood cells (WBC) <3.0 x10^3/microliter (μL) Absolute neutrophil count (ANC) <2.0 x10^3/μL Absolute lymphocyte count <0.5 x10^3/μL Platelet count <10 x 10^4/μL Aspartate aminotransferase (AST) or alanine aminotranferase (ALT) >1.5 times the upper limit of normal (ULN) * If retest is conducted, the last value of retest before randomization must meet study criteria. For adolescents who may be enrolled after the end of the double-blind period, the annotation in the exclusion criterion 20 is as follows (other criteria are same): * If retest is conducted, the last value of retest before baseline 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
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Hopital de Hautepierre CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
NeuroCure Clinical Research Center (NCRC)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Josef-Hospital, Klinik für Neurologie
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Heinrich-Heine Universitätsklinik Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Jahn Ferenc Dél-Pesti Kórház
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
City
Roma
State/Province
Lazio
ZIP/Postal Code
189
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fond. Ist. S. Raffaele - giglio
City
Cefalu
State/Province
Sicilia
ZIP/Postal Code
90015
Country
Italy
Facility Name
Juntendo University Hospital; Neurology
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Kyushu University Hospital; Neurology
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University Hospital; Neurology
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital; Neurology
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Kindai University Hospital; Neurology
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tohoku University Hospital; Neurology
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital; Neurology
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Osaka University Hospital; Neurology
City
Suita
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Centrum Medyczne Dendryt
City
Katowice
ZIP/Postal Code
40-684
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
City
Pozna?
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warsaw
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Klinicznyi
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology
City
Kwei Shen
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
China Medical University Hospital; Neurology - Taichung
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
National Taiwan University Hospital; Neurology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital-Neurology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Kharkivska miska dytiacha likarnia # 5
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
City
Dnipropetrovsk
State/Province
Tavria Okruha
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
University Hospital of Wales; Dept of Neurology
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
John Radcliffe Hospital; Neurosciences
City
Chinnor
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Great Ormond Street Hospital For Children; Neurology
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom

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
31774956
Citation
Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, Tsai CP, Saiz A, Yamazaki H, Kawata Y, Wright P, De Seze J. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019 Nov 28;381(22):2114-2124. doi: 10.1056/NEJMoa1901747.
Results Reference
derived

Learn more about this trial

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

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