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

• ClinicalTrials.gov Identifier: NCT02073279
• Recruitment Status: Completed
• First Posted: February 27, 2014
• Results First Posted: December 31, 2020
• Last Update Posted: March 1, 2023
• Sponsor: Hoffmann-La Roche
• Collaborator: Chugai Pharmaceutical
• Information provided by (Responsible Party): Hoffmann-La Roche

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.

Condition or disease	Intervention/treatment	Phase
Neuromyelitis Optica (NMO); NMO Spectrum Disorder (NMOSD)	Drug: Satralizumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 5, 2014
• Actual Primary Completion Date: October 12, 2018
• Actual Study Completion Date: January 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Satralizumab; 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.	Drug: Satralizumab; Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).; Other Names: SA237; RG6168
Placebo Comparator: Placebo; 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.	Drug: Satralizumab; Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).; Other Names: SA237; RG6168; Drug: Placebo; Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

Outcome Measures

Primary Outcome Measures :

1. Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period [ Time Frame: Up to Week 216 ]
   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 :

1. Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period [ Time Frame: Baseline, Week 24 ]
   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).
2. Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period [ Time Frame: Baseline, Week 24 ]
   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.
3. Relapse-Free Rate During the DB Period [ Time Frame: Up to Week 216 ]
   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.
4. Annualized Relapse Rate (ARR) During the DB Period [ Time Frame: Up to Week 216 ]
   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.
5. Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
   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.
6. Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
   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.
7. Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
   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.
8. Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
   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.
9. Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
   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.
10. Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
11. Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
12. Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
13. Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
14. Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
15. Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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
16. Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
17. Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
18. Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 120 ]
    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.
19. Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
20. Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
21. Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period [ Time Frame: Baseline up to Week 216 ]
    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.
22. Number of Participants With at Least One Adverse Event in the DB Period [ Time Frame: Up to Week 216 ]
    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.
23. Number of Participants With at Least One Serious Adverse Event in the DB Period [ Time Frame: Up to Week 216 ]
    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.
24. Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period [ Time Frame: Up to Week 216 ]

    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.

25. Number of Participants With Selected Adverse Events in the DB Period [ Time Frame: Up to Week 216 ]

    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).

26. Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period [ Time Frame: Baseline and Post-Baseline (up to Week 216) ]
    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.
27. 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 ]
28. 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 ]
29. 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 ]
30. 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 ]
31. Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period [ Time Frame: Up to approximately Week 216 ]
    Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Colorado

University of Colorado Denver -; Neurology

Aurora, Colorado, United States, 80045

United States, Florida

University of Miami UHealth Professional Arts Center

Miami, Florida, United States, 33136

The MS Center of Vero Beach

Vero Beach, Florida, United States, 32962

United States, Georgia

Columbus Research and Wellness

Columbus, Georgia, United States, 31909

United States, Illinois

University of Chicago; Neurology

Chicago, Illinois, United States, 60637

Consultants in Neurology Ltd

Northbrook, Illinois, United States, 60062

OSF Saint Francis Medical Center

Peoria, Illinois, United States, 64637

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

MidAmerica Neuroscience Institute

Prairie Village, Kansas, United States, 66206

United States, Michigan

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109-0666

Wayne State University - Comp Clinic and MS. Center

Detroit, Michigan, United States, 48201

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

The Neurological Institute PA

Charlotte, North Carolina, United States, 28204

United States, Ohio

OhioHealth Research Institute

Columbus, Ohio, United States, 43214

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Central Texas Neurology Consultants

Round Rock, Texas, United States, 78681

UT Medicine San Antonio

San Antonio, Texas, United States, 78229

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23219-1901

United States, Wisconsin

Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

Milwaukee, Wisconsin, United States, 53215

Bulgaria

Medical Help Center EOOD

Dobrich, Bulgaria, 9300

MMA-MHAT Pleven - Clinic for Neurology

Pleven, Bulgaria, 5800

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria, 5800

MHATNP Sveti Naum EAD

Sofia, Bulgaria, 1113

UMHAT Alexandrovska, EAD

Sofia, Bulgaria, 1431

Canada, British Columbia

MS Clinical Trials Group

Vancouver, British Columbia, Canada, V6T 1Z3

Canada, Quebec

Recherche Sepmus Inc.

Greenfield Park, Quebec, Canada, J4V 2J2

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada, H2X 0A9

Croatia

Klinicki bolnicki centar Osijek

Osijek, Croatia, 31000

Georgia

LTD Helsicore

Tbilisi, Georgia, 0112

Pineo Medical Ecosystem LTD

Tbilisi, Georgia, 0114

S.Khechinashvili Tbilisi State Medical University Clinic Ne

Tbilisi, Georgia, 0179

Italy

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, Sicilia, Italy, 95123

Korea, Republic of

Korea University Anam Hospital - Neurology

Seoul, Korea, Republic of, 02841

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Asan Medical Center

Seoul, Korea, Republic of, 05505

Severance Hospital - Yonsei University Health System - Neurology

Seoul, Korea, Republic of, 3722

Malaysia

Hospital Universiti Sains Malaysia [Neurology]

Kubang Kerian, Kelantan, Malaysia, 16150

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

Philippines

Philippine General Hospital

Manila, Philippines, 1000

Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, Poland, 40-123

Miedzyleski Szpital Specjalistyczny w Warszawie

Warszawa, Poland, 04-749

Puerto Rico

San Juan MS Center

Guaynabo, Puerto Rico, 00968

Romania

SC Clubul Sanatatii SRL

Campulung, Romania, 115100

Taiwan

China Medical University Healthcare System

Taichung, Taiwan, 40447

National Cheng Kung University Hospital; Neurology

Tainan, Taiwan, 704

Taipei Veterans General Hospital-Neurology

Taipei, Taiwan, 11217

Turkey

Bilim University Medical Faculty Florence Nightingale Hospital

Istanbul, Turkey, 34333

Ondokuz Mayis Univ. Med. Fac.

Samsun, Turkey, 55139

Ukraine

Ivano-Frankivska oblasna klinichna likarnia

Ivano-Frankivsk, KIEV Governorate, Ukraine, 76008

Ivano-Frankivska miska klinichna likarnia №1

Ivano-Frankivsk, KIEV Governorate, Ukraine, 76018

Kiev National Medical University

Kiev, KIEV Governorate, Ukraine, 3110

Municipal Foundation of Kyiv Regional Council " Kyiv Region

Kyiv, KIEV Governorate, Ukraine, 4107

Reginal clinical psyconeurological hospital

Ternopil, KIEV Governorate, Ukraine, 46014

Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr

Vinnytsya, Poltava Governorate, Ukraine, 21005

Municipal Establishment "City Clinical Hospital #2; Neurology

Zaporozhya, Poltava Governorate, Ukraine, 69068

Miska Klinichna Likarnia №16

Dnipropetrovsk, Tavria Okruha, Ukraine, 49100

KU "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

Odesa, Tavria Okruha, Ukraine, 65006

Sponsors and Collaborators

Hoffmann-La Roche

Chugai Pharmaceutical

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] April 3, 2020

Statistical Analysis Plan  [PDF] November 26, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02073279
• Other Study ID Numbers: BN40900; SA-309JG ( Other Identifier: Chugai Pharmaceutical ); 2015-005431-41 ( EudraCT Number )
• First Posted: February 27, 2014
• Results First Posted: December 31, 2020
• Last Update Posted: March 1, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neuromyelitis Optica; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases