Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02028884
Collaborator
Chugai Pharmaceutical (Industry)
83
39
2
94.1
2.1
0
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
83 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Feb 20, 2014
Actual Primary Completion Date
:
Jun 6, 2018
Actual Study Completion Date
:
Dec 23, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Satralizumab + Baseline Treatment 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. |
Drug: Satralizumab
Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Other Names:
Drug: Baseline Treatment
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.
|
| Placebo Comparator: Placebo + Baseline Treatment 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. |
Drug: Placebo
Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Drug: Baseline Treatment
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.
|
Outcome Measures
Primary Outcome Measures
- Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period [Up to Week 224]
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 [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).
- Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [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. ANCOVA was used for analysis to report the adjusted mean and SE.
- Relapse-Free Rate During the DB Period [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.
- Annualized Relapse Rate (ARR) During the DB Period [Up to Week 216]
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 [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.
- Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period [Baseline up to Week 168]
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 [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.
- Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period [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.
- Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period [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.
- Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period [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.
- Serum Satralizumab Concentration During the DB Period [Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 224]
- Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period [Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224]
- Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period [Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224]
- Serum Interleukin-6 (IL-6) Concentration During the DB Period [Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224]
- Number of Participants With at Least One Adverse Event in the DB Period [Up to Week 224]
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 [Up to Week 224]
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 [Up to Week 224]
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 [Up to Week 224]
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 [Baseline and Post-Baseline (up to Week 224)]
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.
- Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time [Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period; every 24 weeks for first 48 weeks of open-label extension period (up to approximately 7 years)]
- Percentage of Blood Plasmablast Over Time [Baseline, Weeks 2, 4, 8, 12, 24, 48 and every 24 weeks thereafter of double-blind period (up to approximately 30 months)]
- Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period [Up to approximately Week 224]
Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | Hopital de Hautepierre CHRU de Strasbourg | Strasbourg | France | 67091 | |
| 3 | NeuroCure Clinical Research Center (NCRC) | Berlin | Germany | 10117 | |
| 4 | St. Josef-Hospital, Klinik für Neurologie | Bochum | Germany | 44791 | |
| 5 | Heinrich-Heine Universitätsklinik Düsseldorf | Düsseldorf | Germany | 40225 | |
| 6 | Jahn Ferenc Dél-Pesti Kórház | Budapest | Hungary | 1204 | |
| 7 | Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien | Roma | Lazio | Italy | 189 |
| 8 | Ospedale San Raffaele | Milano | Lombardia | Italy | 20132 |
| 9 | PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania | Catania | Sicilia | Italy | 95123 |
| 10 | Fond. Ist. S. Raffaele - giglio | Cefalu | Sicilia | Italy | 90015 |
| 11 | Juntendo University Hospital; Neurology | Bunkyo-ku | Japan | 113-8431 | |
| 12 | Kyushu University Hospital; Neurology | Fukuoka | Japan | 812-8582 | |
| 13 | Fukushima Medical University Hospital; Neurology | Fukushima | Japan | 960-1295 | |
| 14 | Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics | Kagoshima | Japan | 890-8520 | |
| 15 | Niigata University Medical and Dental Hospital; Neurology | Niigata | Japan | 951-8520 | |
| 16 | Kindai University Hospital; Neurology | Osaka | Japan | 589-8511 | |
| 17 | Tohoku University Hospital; Neurology | Sendai | Japan | 980-8574 | |
| 18 | Tokyo Women's Medical University Hospital; Neurology | Shinjuku-ku | Japan | 162-8666 | |
| 19 | Osaka University Hospital; Neurology | Suita | Japan | 565-0871 | |
| 20 | National Center of Neurology and Psychiatry | Tokyo | Japan | 187-8551 | |
| 21 | NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS | Katowice | Poland | 40-123 | |
| 22 | M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM | Katowice | Poland | 40-571 | |
| 23 | Centrum Medyczne Dendryt | Katowice | Poland | 40-684 | |
| 24 | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland | 20-954 | |
| 25 | Szpital Kliniczny im. H.Swiecickiego UM im.K.Marcinkowskiego | Poznań | Poland | 60-355 | |
| 26 | Instytut Psychiatrii i Neurologii | Warsaw | Poland | ||
| 27 | Samodzielny Publiczny Centralny Szpital Klinicznyi | Warszawa | Poland | 02-097 | |
| 28 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
| 29 | Hospital Clinico San Carlos; Servicio de Nefrologia | Madrid | Spain | 28040 | |
| 30 | Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology | Kwei Shen | Taiwan | 33305 | |
| 31 | China Medical University Hospital; Neurology - Taichung | Taichung | Taiwan | 40447 | |
| 32 | National Cheng Kung University Hospital; Neurology | Tainan | Taiwan | 704 | |
| 33 | National Taiwan University Hospital; Neurology | Taipei | Taiwan | 100 | |
| 34 | Taipei Veterans General Hospital-Neurology | Taipei | Taiwan | 11217 | |
| 35 | Kharkivska miska dytiacha likarnia # 5 | Kharkiv | Kharkiv Governorate | Ukraine | 61000 |
| 36 | KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR | Dnipropetrovsk | Tavria Okruha | Ukraine | 49100 |
| 37 | University Hospital of Wales; Dept of Neurology | Cardiff | United Kingdom | CF14 4XW | |
| 38 | Great Ormand Street Hospital For Children; Neurology | London | United Kingdom | WC1N 3JH | |
| 39 | John Radcliffe Hospital; Neurosciences | Oxford | United Kingdom | OX3 9DU |
Sponsors and Collaborators
- Hoffmann-La Roche
- Chugai Pharmaceutical
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02028884
Other Study ID Numbers:
- BN40898
- 2013-003752-21
- SA-307JG
First Posted:
Jan 7, 2014
Last Update Posted:
Feb 17, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the double-blind (DB) period up to the clinical cut-off date (CCOD: 06 June 2018). The CCOD was defined by the onset date of the 26th clinical endpoint committee-confirmed protocol-defined relapse (PDR). The study is ongoing in the open-label extension (OLE) period. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo + Baseline Treatment, Then Satralizumab | Satralizumab + Baseline Treatment, Then Satralizumab |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Period Title: Double-blind Period | ||
| STARTED | 42 | 41 |
| COMPLETED | 24 | 18 |
| NOT COMPLETED | 18 | 23 |
| Period Title: Double-blind Period | ||
| STARTED | 24 | 18 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 24 | 18 |
Baseline Characteristics
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment | Total |
|---|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Total of all reporting groups |
| Overall Participants | 42 | 41 | 83 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
43.38
(12.03)
|
40.78
(16.09)
|
42.10
(14.16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
40
95.2%
|
37
90.2%
|
77
92.8%
|
| Male |
2
4.8%
|
4
9.8%
|
6
7.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Not Hispanic or Latino |
40
95.2%
|
41
100%
|
81
97.6%
|
| Not Stated |
2
4.8%
|
0
0%
|
2
2.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian |
18
42.9%
|
17
41.5%
|
35
42.2%
|
| Black or African American |
2
4.8%
|
0
0%
|
2
2.4%
|
| White |
21
50%
|
24
58.5%
|
45
54.2%
|
| Other |
1
2.4%
|
0
0%
|
1
1.2%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. For participants who had not relapsed, the TFR was censored on the date of end of the DB period. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Median (95% Confidence Interval) [weeks] |
120.6
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo + Baseline Treatment, Satralizumab + Baseline Treatment |
|---|---|---|
| Comments | Stratified by Baseline annualized relapse rate (ARR: 1, > 1) and geographic region (Asia, EU/Other). | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0184 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.38 | |
| Confidence Interval |
(2-Sided) 95% 0.16 to 0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data were imputed by baseline observation carried forward (BOCF) method. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
34.619
(4.026)
|
27.561
(4.399)
|
| Change from Baseline at Week 24 |
-3.505
(2.357)
|
2.871
(2.391)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo + Baseline Treatment, Satralizumab + Baseline Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0602 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.376 | |
| Confidence Interval |
(2-Sided) 95% -0.280 to 13.033 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.344 |
|
| Estimation Comments | ||
| Title | Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. Missing data was imputed using BOCF method |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
33.857
(1.746)
|
34.732
(1.646)
|
| Change from Baseline at Week 24 |
2.234
(0.943)
|
0.145
(0.963)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo + Baseline Treatment, Satralizumab + Baseline Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1224 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.089 | |
| Confidence Interval |
(2-Sided) 95% -4.752 to 0.574 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.338 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 34 | 37 |
| Week 12 |
89.86
214%
|
94.99
231.7%
|
| Week 24 |
84.41
201%
|
88.86
216.7%
|
| Week 36 |
69.49
165.5%
|
88.86
216.7%
|
| Week 48 |
66.02
157.2%
|
88.86
216.7%
|
| Week 72 |
58.68
139.7%
|
81.46
198.7%
|
| Week 96 |
58.68
139.7%
|
77.58
189.2%
|
| Week 120 |
54.17
129%
|
73.70
179.8%
|
| Week 144 |
49.24
117.2%
|
73.70
179.8%
|
| Week 168 |
43.77
104.2%
|
73.70
179.8%
|
| Week 192 |
73.70
175.5%
|
|
| Week 216 |
73.70
175.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Number (95% Confidence Interval) [patients w relapse/patient-years at risk] |
0.32
|
0.11
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
1.55
(0.97)
|
1.90
(1.14)
|
| Change from Baseline at Week 24 |
-0.03
(0.42)
|
-0.03
(0.50)
|
| Change from Baseline at Week 48 |
-0.18
(0.53)
|
-0.13
(0.45)
|
| Change from Baseline at Week 72 |
0.07
(0.70)
|
0.00
(0.52)
|
| Change from Baseline at Week 96 |
0.13
(0.62)
|
-0.19
(0.51)
|
| Change from Baseline at Week 120 |
-0.10
(0.74)
|
-0.05
(0.51)
|
| Change from Baseline at Week 144 |
-0.11
(0.93)
|
-0.20
(0.41)
|
| Change from Baseline at Week 168 |
-0.67
(0.58)
|
-0.11
(0.33)
|
| Change from Baseline at Week 192 |
-0.50
(0.71)
|
|
| Change from Baseline at Week 216 |
0.00
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 16 | 13 |
| Baseline |
19.31
(9.31)
|
18.92
(12.82)
|
| Change from Baseline at Week 24 |
-3.44
(5.59)
|
-3.57
(7.11)
|
| Change from Baseline at Week 48 |
1.17
(8.26)
|
1.13
(13.45)
|
| Change from Baseline at Week 72 |
2.20
(19.64)
|
-0.71
(11.60)
|
| Change from Baseline at Week 96 |
3.00
(14.98)
|
4.17
(13.33)
|
| Change from Baseline at Week 120 |
0.00
(3.61)
|
3.40
(9.29)
|
| Change from Baseline at Week 144 |
-3.50
(12.02)
|
-3.50
(11.33)
|
| Change from Baseline at Week 168 |
2.50
(13.44)
|
11.00
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 41 | 41 |
| Baseline |
3.63
(1.32)
|
3.83
(1.57)
|
| Change from Baseline at Week 24 |
-0.21
(0.68)
|
-0.14
(0.82)
|
| Change from Baseline at Week 48 |
-0.19
(0.77)
|
-0.19
(0.67)
|
| Change from Baseline at Week 72 |
-0.27
(0.68)
|
-0.29
(0.73)
|
| Change from Baseline at Week 96 |
-0.19
(0.81)
|
-0.19
(0.75)
|
| Change from Baseline at Week 120 |
-0.30
(0.79)
|
0.03
(0.57)
|
| Change from Baseline at Week 144 |
-0.33
(0.83)
|
-0.07
(0.62)
|
| Change from Baseline at Week 168 |
-0.17
(0.76)
|
-0.06
(0.58)
|
| Change from Baseline at Week 192 |
0.00
(0.71)
|
|
| Change from Baseline at Week 216 |
-0.50
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline: OD |
0.490
(0.928)
|
0.303
(0.593)
|
| Baseline: OS |
0.526
(0.911)
|
0.597
(1.016)
|
| Change from Baseline at Week 24: OD |
-0.064
(0.197)
|
0.042
(0.236)
|
| Change from Baseline at Week 24: OS |
-0.012
(0.107)
|
0.059
(0.319)
|
| Change from Baseline at Week 48: OD |
-0.019
(0.086)
|
0.008
(0.093)
|
| Change from Baseline at Week 48: OS |
0.026
(0.096)
|
0.013
(0.061)
|
| Change from Baseline at Week 72: OD |
-0.001
(0.110)
|
-0.034
(0.111)
|
| Change from Baseline at Week 72: OS |
-0.001
(0.121)
|
-0.019
(0.077)
|
| Change from Baseline at Week 96: OD |
0.018
(0.174)
|
-0.013
(0.095)
|
| Change from Baseline at Week 96: OS |
-0.078
(0.185)
|
-0.010
(0.073)
|
| Change from Baseline at Week 120: OD |
0.030
(0.150)
|
0.011
(0.103)
|
| Change from Baseline at Week 120: OS |
-0.024
(0.150)
|
0.014
(0.257)
|
| Change from Baseline at Week 144: OD |
0.058
(0.231)
|
-0.016
(0.120)
|
| Change from Baseline at Week 144: OS |
-0.016
(0.165)
|
-0.028
(0.111)
|
| Change from Baseline at Week 168: OD |
0.113
(0.306)
|
0.027
(0.199)
|
| Change from Baseline at Week 168: OS |
0.100
(0.173)
|
-0.024
(0.113)
|
| Change from Baseline at Week 192: OD |
0.150
(0.099)
|
|
| Change from Baseline at Week 192: OS |
0.000
(0.000)
|
|
| Change from Baseline at Week 216: OD |
0.120
(NA)
|
|
| Change from Baseline at Week 216: OS |
0.000
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
44.77
(11.08)
|
44.56
(9.75)
|
| Change from Baseline at Week 24 |
2.53
(7.58)
|
0.57
(8.99)
|
| Change from Baseline at Week 48 |
2.78
(7.51)
|
-0.61
(10.97)
|
| Change from Baseline at Week 72 |
3.47
(7.13)
|
2.78
(8.13)
|
| Change from Baseline at Week 96 |
5.16
(10.52)
|
1.06
(7.63)
|
| Change from Baseline at Week 120 |
3.63
(8.62)
|
0.71
(7.23)
|
| Change from Baseline at Week 144 |
2.83
(8.79)
|
3.82
(7.15)
|
| Change from Baseline at Week 168 |
2.79
(6.85)
|
3.60
(9.50)
|
| Change from Baseline at Week 192 |
11.60
(7.32)
|
|
| Change from Baseline at Week 216 |
14.05
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
41.54
(9.11)
|
43.60
(10.47)
|
| Change from Baseline at Week 24 |
2.79
(5.61)
|
1.30
(6.01)
|
| Change from Baseline at Week 48 |
0.18
(5.33)
|
1.22
(5.77)
|
| Change from Baseline at Week 72 |
1.97
(6.23)
|
1.16
(4.79)
|
| Change from Baseline at Week 96 |
-1.15
(7.52)
|
1.88
(5.72)
|
| Change from Baseline at Week 120 |
-0.13
(7.10)
|
2.34
(6.60)
|
| Change from Baseline at Week 144 |
1.78
(5.50)
|
3.05
(4.23)
|
| Change from Baseline at Week 168 |
0.22
(9.23)
|
0.76
(5.98)
|
| Change from Baseline at Week 192 |
0.23
(0.55)
|
|
| Change from Baseline at Week 216 |
-1.63
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
43.91
(10.22)
|
45.94
(11.56)
|
| Change from Baseline at Week 24 |
2.71
(7.06)
|
0.03
(11.06)
|
| Change from Baseline at Week 48 |
0.81
(5.60)
|
0.12
(6.99)
|
| Change from Baseline at Week 72 |
3.55
(8.20)
|
2.30
(6.99)
|
| Change from Baseline at Week 96 |
1.31
(7.13)
|
1.15
(8.86)
|
| Change from Baseline at Week 120 |
2.22
(9.96)
|
-1.45
(9.13)
|
| Change from Baseline at Week 144 |
3.58
(8.53)
|
3.14
(8.18)
|
| Change from Baseline at Week 168 |
1.61
(10.58)
|
3.05
(9.00)
|
| Change from Baseline at Week 192 |
8.07
(0.57)
|
|
| Change from Baseline at Week 216 |
3.63
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
39.65
(7.90)
|
41.23
(9.29)
|
| Change from Baseline at Week 24 |
1.84
(5.68)
|
-0.60
(7.26)
|
| Change from Baseline at Week 48 |
-0.66
(5.53)
|
-0.27
(6.00)
|
| Change from Baseline at Week 72 |
-0.16
(6.25)
|
0.94
(5.57)
|
| Change from Baseline at Week 96 |
-1.90
(6.17)
|
1.86
(6.12)
|
| Change from Baseline at Week 120 |
-0.33
(4.03)
|
3.76
(6.72)
|
| Change from Baseline at Week 144 |
-0.95
(5.66)
|
5.20
(7.11)
|
| Change from Baseline at Week 168 |
-5.23
(7.41)
|
3.06
(6.99)
|
| Change from Baseline at Week 192 |
1.19
(5.04)
|
|
| Change from Baseline at Week 216 |
-2.38
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
43.71
(10.92)
|
43.59
(10.55)
|
| Change from Baseline at Week 24 |
5.23
(7.69)
|
0.99
(10.21)
|
| Change from Baseline at Week 48 |
2.76
(8.54)
|
0.11
(10.73)
|
| Change from Baseline at Week 72 |
5.23
(7.66)
|
3.18
(9.72)
|
| Change from Baseline at Week 96 |
4.09
(8.49)
|
2.12
(8.13)
|
| Change from Baseline at Week 120 |
3.14
(7.06)
|
1.57
(6.76)
|
| Change from Baseline at Week 144 |
3.49
(7.04)
|
4.88
(8.38)
|
| Change from Baseline at Week 168 |
4.36
(3.02)
|
4.07
(10.72)
|
| Change from Baseline at Week 192 |
13.09
(14.80)
|
|
| Change from Baseline at Week 216 |
23.55
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
42.50
(10.53)
|
43.46
(10.34)
|
| Change from Baseline at Week 24 |
3.56
(7.04)
|
1.49
(7.05)
|
| Change from Baseline at Week 48 |
1.92
(4.30)
|
1.86
(7.73)
|
| Change from Baseline at Week 72 |
3.19
(6.54)
|
0.88
(6.52)
|
| Change from Baseline at Week 96 |
0.84
(6.77)
|
2.37
(7.75)
|
| Change from Baseline at Week 120 |
-0.19
(8.39)
|
2.58
(6.03)
|
| Change from Baseline at Week 144 |
2.55
(4.06)
|
3.32
(5.72)
|
| Change from Baseline at Week 168 |
1.92
(5.06)
|
0.00
(5.50)
|
| Change from Baseline at Week 192 |
1.91
(2.70)
|
|
| Change from Baseline at Week 216 |
1.91
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
43.98
(11.46)
|
43.01
(10.55)
|
| Change from Baseline at Week 24 |
2.24
(10.35)
|
0.36
(10.12)
|
| Change from Baseline at Week 48 |
3.29
(8.05)
|
0.00
(12.49)
|
| Change from Baseline at Week 72 |
1.39
(9.38)
|
2.57
(7.66)
|
| Change from Baseline at Week 96 |
4.13
(14.40)
|
0.83
(10.20)
|
| Change from Baseline at Week 120 |
3.13
(12.44)
|
0.35
(6.95)
|
| Change from Baseline at Week 144 |
3.09
(9.61)
|
3.25
(7.38)
|
| Change from Baseline at Week 168 |
1.16
(5.32)
|
4.64
(9.05)
|
| Change from Baseline at Week 192 |
12.19
(2.46)
|
|
| Change from Baseline at Week 216 |
6.97
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
40.74
(10.12)
|
41.88
(11.38)
|
| Change from Baseline at Week 24 |
3.93
(9.56)
|
3.02
(6.95)
|
| Change from Baseline at Week 48 |
1.37
(7.23)
|
1.40
(8.66)
|
| Change from Baseline at Week 72 |
2.40
(7.94)
|
2.83
(7.81)
|
| Change from Baseline at Week 96 |
0.42
(9.03)
|
1.71
(4.60)
|
| Change from Baseline at Week 120 |
1.57
(9.47)
|
3.14
(7.44)
|
| Change from Baseline at Week 144 |
2.99
(6.05)
|
2.69
(6.80)
|
| Change from Baseline at Week 168 |
3.74
(10.61)
|
2.25
(6.45)
|
| Change from Baseline at Week 192 |
4.49
(6.35)
|
|
| Change from Baseline at Week 216 |
8.98
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
41.70
(11.62)
|
44.26
(10.92)
|
| Change from Baseline at Week 24 |
1.73
(7.96)
|
0.86
(8.69)
|
| Change from Baseline at Week 48 |
1.12
(7.80)
|
0.00
(10.24)
|
| Change from Baseline at Week 72 |
2.34
(7.78)
|
2.18
(7.22)
|
| Change from Baseline at Week 96 |
2.82
(11.72)
|
0.00
(9.38)
|
| Change from Baseline at Week 120 |
1.51
(13.59)
|
0.25
(9.13)
|
| Change from Baseline at Week 144 |
0.56
(9.85)
|
2.01
(7.29)
|
| Change from Baseline at Week 168 |
1.67
(22.61)
|
0.00
(5.61)
|
| Change from Baseline at Week 192 |
0.00
(0.00)
|
|
| Change from Baseline at Week 216 |
-5.01
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
45.95
(9.14)
|
46.66
(9.65)
|
| Change from Baseline at Week 24 |
2.66
(7.38)
|
1.74
(8.61)
|
| Change from Baseline at Week 48 |
1.65
(5.60)
|
-0.25
(8.71)
|
| Change from Baseline at Week 72 |
4.55
(6.91)
|
1.38
(9.12)
|
| Change from Baseline at Week 96 |
4.08
(8.53)
|
2.41
(8.28)
|
| Change from Baseline at Week 120 |
2.97
(5.24)
|
2.67
(8.45)
|
| Change from Baseline at Week 144 |
3.96
(6.12)
|
4.16
(10.03)
|
| Change from Baseline at Week 168 |
2.97
(2.97)
|
0.99
(10.82)
|
| Change from Baseline at Week 192 |
7.43
(10.51)
|
|
| Change from Baseline at Week 216 |
11.89
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants randomized to the treatment groups. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 40 |
| Baseline |
0.7297
(0.1863)
|
0.7634
(0.1811)
|
| Change from Baseline at Week 24 |
0.0649
(0.1596)
|
-0.0082
(0.1882)
|
| Change from Baseline at Week 48 |
0.0352
(0.1830)
|
0.0011
(0.1256)
|
| Change from Baseline at Week 72 |
0.0724
(0.2088)
|
0.0241
(0.1084)
|
| Change from Baseline at Week 96 |
0.0349
(0.1758)
|
0.0167
(0.1056)
|
| Change from Baseline at Week 120 |
0.0336
(0.2111)
|
0.0257
(0.1178)
|
| Change from Baseline at Week 144 |
0.0846
(0.1650)
|
0.0488
(0.1424)
|
| Change from Baseline at Week 168 |
0.0648
(0.1031)
|
0.0307
(0.1335)
|
| Change from Baseline at Week 192 |
0.1873
(0.2890)
|
|
| Change from Baseline at Week 216 |
0.3322
(NA)
|
| Title | Serum Satralizumab Concentration During the DB Period |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 224 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from Safety Analysis Population (SAF) who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Satralizumab + Baseline Treatment |
|---|---|
| Arm/Group Description | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 41 |
| Baseline |
100.00
(0.00)
|
| Week 2 |
11343.66
(5125.84)
|
| Week 4 |
22222.63
(8003.48)
|
| Week 5 |
28461.00
(12542.52)
|
| Week 6 |
28174.50
(11199.00)
|
| Week 8 |
21246.92
(9045.31)
|
| Week 12 |
20927.63
(9536.07)
|
| Week 16 |
20274.86
(10694.38)
|
| Week 20 |
20146.06
(10740.65)
|
| Week 24 |
20189.00
(10140.88)
|
| Week 28 |
20826.07
(10995.92)
|
| Week 32 |
20631.79
(11110.94)
|
| Week 36 |
21114.62
(11190.52)
|
| Week 40 |
22224.76
(13389.71)
|
| Week 44 |
22582.17
(12031.13)
|
| Week 48 |
23324.80
(13979.87)
|
| Week 52 |
24570.83
(15798.38)
|
| Week 56 |
24252.50
(15433.80)
|
| Week 60 |
23061.67
(15777.82)
|
| Week 64 |
23369.55
(13447.96)
|
| Week 68 |
26194.43
(16836.77)
|
| Week 72 |
26618.87
(14999.38)
|
| Week 76 |
26539.09
(13736.30)
|
| Week 80 |
26868.00
(14005.87)
|
| Week 84 |
27037.62
(15460.97)
|
| Week 88 |
26203.00
(14309.81)
|
| Week 92 |
28308.10
(15111.34)
|
| Week 96 |
26754.43
(15146.20)
|
| Week 100 |
27707.14
(14225.93)
|
| Week 104 |
26203.81
(13616.28)
|
| Week 108 |
26112.38
(12521.65)
|
| Week 112 |
24925.10
(12181.81)
|
| Week 116 |
26360.50
(13885.76)
|
| Week 120 |
24910.00
(13217.57)
|
| Week 124 |
24689.50
(14352.30)
|
| Week 128 |
22395.53
(12954.00)
|
| Week 132 |
23804.74
(14878.32)
|
| Week 136 |
25856.32
(15506.85)
|
| Week 140 |
26118.56
(15264.89)
|
| Week 144 |
27975.33
(11536.28)
|
| Week 148 |
27935.83
(11940.90)
|
| Week 152 |
28967.00
(10354.22)
|
| Week 156 |
27990.00
(10444.75)
|
| Week 160 |
28983.33
(11429.02)
|
| Week 164 |
28903.33
(10780.69)
|
| Week 168 |
23683.33
(11615.40)
|
| Week 172 |
24498.89
(11106.23)
|
| Week 176 |
26300.00
(11498.48)
|
| Week 180 |
28300.00
(9431.86)
|
| Week 184 |
32380.00
(9427.19)
|
| Week 188 |
36600.00
(8214.62)
|
| Week 192 |
32650.00
(7848.89)
|
| Week 196 |
30800.00
(4808.33)
|
| Week 200 |
28400.00
(3818.38)
|
| Week 204 |
25300.00
(3252.69)
|
| Week 208 |
25900.00
(NA)
|
| Week 212 |
17000.00
(NA)
|
| Week 216 |
28600.00
(NA)
|
| Week 220 |
31600.00
(NA)
|
| Week 224 |
28700.00
(NA)
|
| Title | Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
32.52
(7.78)
|
35.13
(21.52)
|
| Week 2 |
33.82
(8.30)
|
437.41
(72.31)
|
| Week 4 |
33.13
(8.52)
|
572.29
(94.84)
|
| Week 8 |
34.02
(9.43)
|
642.92
(115.51)
|
| Week 12 |
32.58
(8.52)
|
651.41
(99.20)
|
| Week 16 |
32.67
(9.32)
|
640.57
(97.41)
|
| Week 20 |
34.22
(8.15)
|
636.64
(109.75)
|
| Week 24 |
34.44
(9.31)
|
639.20
(108.94)
|
| Week 28 |
33.70
(8.28)
|
649.11
(131.85)
|
| Week 32 |
33.48
(8.74)
|
651.82
(162.04)
|
| Week 36 |
34.39
(11.01)
|
652.12
(124.70)
|
| Week 40 |
33.31
(7.86)
|
664.21
(158.61)
|
| Week 44 |
33.94
(7.77)
|
677.13
(173.99)
|
| Week 48 |
34.50
(9.14)
|
627.23
(217.06)
|
| Week 52 |
44.01
(44.26)
|
656.29
(173.67)
|
| Week 56 |
37.00
(7.42)
|
626.83
(155.56)
|
| Week 60 |
36.39
(7.81)
|
617.00
(142.13)
|
| Week 64 |
35.14
(8.78)
|
621.27
(152.45)
|
| Week 68 |
35.35
(8.68)
|
664.91
(130.58)
|
| Week 72 |
36.02
(10.73)
|
648.83
(134.32)
|
| Week 76 |
36.94
(9.46)
|
643.91
(118.60)
|
| Week 80 |
36.45
(9.50)
|
667.24
(133.49)
|
| Week 84 |
34.60
(8.88)
|
649.38
(137.64)
|
| Week 88 |
31.95
(8.29)
|
651.35
(150.58)
|
| Week 92 |
34.30
(9.71)
|
633.43
(134.36)
|
| Week 96 |
32.88
(9.39)
|
630.62
(162.28)
|
| Week 100 |
33.78
(9.04)
|
651.90
(162.09)
|
| Week 104 |
31.61
(9.13)
|
649.57
(185.99)
|
| Week 108 |
31.49
(9.23)
|
658.67
(152.61)
|
| Week 112 |
32.75
(7.77)
|
683.90
(135.07)
|
| Week 116 |
33.68
(8.31)
|
653.98
(194.92)
|
| Week 120 |
33.73
(6.20)
|
667.10
(152.24)
|
| Week 124 |
33.06
(9.31)
|
696.45
(138.17)
|
| Week 128 |
34.07
(8.83)
|
670.05
(138.28)
|
| Week 132 |
34.28
(4.95)
|
671.84
(138.75)
|
| Week 136 |
32.43
(8.12)
|
674.95
(170.04)
|
| Week 140 |
32.97
(6.52)
|
645.72
(132.32)
|
| Week 144 |
35.37
(8.91)
|
699.80
(101.84)
|
| Week 148 |
37.97
(12.40)
|
672.42
(107.40)
|
| Week 152 |
35.08
(9.08)
|
701.60
(110.27)
|
| Week 156 |
36.92
(7.77)
|
720.33
(103.58)
|
| Week 160 |
40.38
(7.31)
|
704.89
(109.86)
|
| Week 164 |
43.08
(10.54)
|
723.67
(136.20)
|
| Week 168 |
42.30
(5.92)
|
744.22
(123.47)
|
| Week 172 |
42.03
(5.87)
|
706.33
(127.63)
|
| Week 176 |
39.85
(6.15)
|
730.56
(121.75)
|
| Week 180 |
38.85
(12.09)
|
769.83
(119.50)
|
| Week 184 |
736.80
(152.09)
|
|
| Week 188 |
853.67
(38.02)
|
|
| Week 192 |
930.00
(49.50)
|
|
| Week 196 |
887.00
(91.92)
|
|
| Week 200 |
902.50
(79.90)
|
|
| Week 204 |
935.00
(7.07)
|
|
| Week 208 |
941.00
(NA)
|
|
| Week 212 |
971.00
(NA)
|
|
| Week 216 |
896.00
(NA)
|
|
| Week 220 |
901.00
(NA)
|
|
| Week 224 |
831.00
(NA)
|
| Title | Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
1.48
(2.08)
|
1.68
(2.49)
|
| Week 2 |
1.65
(2.86)
|
0.78
(2.93)
|
| Week 4 |
1.59
(2.27)
|
0.44
(0.72)
|
| Week 8 |
1.76
(2.25)
|
0.59
(1.26)
|
| Week 12 |
1.48
(2.07)
|
0.47
(0.60)
|
| Week 16 |
1.91
(3.34)
|
0.49
(0.51)
|
| Week 20 |
1.91
(3.44)
|
0.48
(0.50)
|
| Week 24 |
2.45
(6.87)
|
0.58
(0.91)
|
| Week 28 |
1.96
(3.24)
|
0.73
(1.34)
|
| Week 32 |
2.36
(4.96)
|
0.73
(1.21)
|
| Week 36 |
2.48
(3.59)
|
0.56
(0.66)
|
| Week 40 |
2.49
(4.53)
|
1.13
(2.26)
|
| Week 44 |
1.41
(1.47)
|
0.72
(1.20)
|
| Week 48 |
1.59
(2.07)
|
0.86
(1.44)
|
| Week 52 |
2.60
(3.87)
|
0.67
(0.88)
|
| Week 56 |
1.43
(1.58)
|
0.72
(1.02)
|
| Week 60 |
2.63
(4.34)
|
1.05
(2.15)
|
| Week 64 |
11.10
(40.09)
|
0.64
(0.89)
|
| Week 68 |
1.86
(2.66)
|
0.57
(0.47)
|
| Week 72 |
3.80
(8.83)
|
0.59
(0.71)
|
| Week 76 |
5.24
(10.68)
|
0.51
(0.37)
|
| Week 80 |
2.11
(2.63)
|
0.58
(0.51)
|
| Week 84 |
2.08
(2.26)
|
0.59
(0.61)
|
| Week 88 |
5.19
(12.83)
|
0.60
(0.53)
|
| Week 92 |
2.07
(2.21)
|
0.60
(0.70)
|
| Week 96 |
2.92
(4.60)
|
0.74
(1.01)
|
| Week 100 |
2.58
(4.53)
|
0.87
(1.49)
|
| Week 104 |
1.41
(2.05)
|
0.84
(1.40)
|
| Week 108 |
1.93
(2.25)
|
0.66
(0.58)
|
| Week 112 |
1.54
(1.56)
|
0.82
(0.87)
|
| Week 116 |
2.39
(3.91)
|
0.84
(1.26)
|
| Week 120 |
1.53
(1.33)
|
0.98
(1.58)
|
| Week 124 |
1.43
(1.43)
|
0.72
(0.67)
|
| Week 128 |
6.00
(16.28)
|
0.96
(1.29)
|
| Week 132 |
1.08
(0.94)
|
0.70
(0.84)
|
| Week 136 |
1.43
(1.54)
|
0.99
(1.68)
|
| Week 140 |
1.15
(1.28)
|
1.06
(2.25)
|
| Week 144 |
0.82
(0.73)
|
0.44
(0.37)
|
| Week 148 |
1.29
(1.43)
|
0.35
(0.18)
|
| Week 152 |
1.08
(0.97)
|
0.38
(0.23)
|
| Week 156 |
1.52
(1.42)
|
0.35
(0.18)
|
| Week 160 |
0.83
(0.53)
|
0.37
(0.22)
|
| Week 164 |
3.18
(4.89)
|
0.38
(0.20)
|
| Week 168 |
0.80
(0.26)
|
0.40
(0.19)
|
| Week 172 |
1.37
(1.00)
|
0.26
(0.17)
|
| Week 176 |
0.95
(0.64)
|
0.31
(0.19)
|
| Week 180 |
30.15
(41.65)
|
0.28
(0.15)
|
| Week 184 |
0.20
(0.11)
|
|
| Week 188 |
0.37
(0.06)
|
|
| Week 192 |
0.15
(0.00)
|
|
| Week 196 |
0.23
(0.11)
|
|
| Week 200 |
0.23
(0.11)
|
|
| Week 204 |
0.23
(0.11)
|
|
| Week 208 |
0.30
(NA)
|
|
| Week 212 |
0.40
(NA)
|
|
| Week 216 |
0.30
(NA)
|
|
| Week 220 |
0.40
(NA)
|
|
| Week 224 |
0.15
(NA)
|
| Title | Serum Interleukin-6 (IL-6) Concentration During the DB Period |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 224 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Baseline |
1.63
(0.39)
|
1.92
(1.36)
|
| Week 2 |
1.84
(0.95)
|
40.12
(118.83)
|
| Week 4 |
2.33
(2.99)
|
28.30
(31.31)
|
| Week 8 |
1.69
(0.55)
|
32.37
(77.99)
|
| Week 12 |
1.71
(0.60)
|
22.95
(20.55)
|
| Week 16 |
1.84
(0.90)
|
25.76
(30.85)
|
| Week 20 |
2.99
(5.45)
|
23.07
(15.37)
|
| Week 24 |
2.02
(1.52)
|
21.53
(17.91)
|
| Week 28 |
1.95
(1.38)
|
25.14
(24.27)
|
| Week 32 |
1.74
(0.84)
|
23.77
(18.53)
|
| Week 36 |
2.13
(1.41)
|
23.08
(15.56)
|
| Week 40 |
1.66
(0.40)
|
27.31
(47.45)
|
| Week 44 |
1.57
(0.00)
|
17.01
(15.38)
|
| Week 48 |
1.69
(0.53)
|
19.45
(19.36)
|
| Week 52 |
2.12
(1.36)
|
21.11
(17.42)
|
| Week 56 |
1.57
(0.00)
|
21.74
(20.96)
|
| Week 60 |
2.27
(1.46)
|
23.25
(23.36)
|
| Week 64 |
2.46
(3.22)
|
24.31
(20.74)
|
| Week 68 |
1.94
(1.14)
|
31.30
(53.79)
|
| Week 72 |
1.93
(0.97)
|
24.69
(24.45)
|
| Week 76 |
2.21
(1.87)
|
20.45
(13.79)
|
| Week 80 |
2.19
(2.51)
|
23.29
(19.64)
|
| Week 84 |
2.66
(2.36)
|
22.71
(21.49)
|
| Week 88 |
2.59
(2.77)
|
29.17
(25.58)
|
| Week 92 |
1.84
(0.77)
|
24.51
(32.02)
|
| Week 96 |
3.06
(3.19)
|
21.52
(20.20)
|
| Week 100 |
2.04
(1.02)
|
21.77
(24.98)
|
| Week 104 |
1.95
(0.96)
|
22.61
(26.55)
|
| Week 108 |
1.76
(0.70)
|
24.18
(20.55)
|
| Week 112 |
1.57
(0.00)
|
32.18
(36.15)
|
| Week 116 |
1.57
(0.00)
|
22.33
(22.20)
|
| Week 120 |
1.71
(0.52)
|
21.86
(24.54)
|
| Week 124 |
1.57
(0.00)
|
26.23
(27.67)
|
| Week 128 |
1.57
(0.00)
|
25.40
(31.20)
|
| Week 132 |
1.57
(0.00)
|
25.48
(27.38)
|
| Week 136 |
1.57
(0.00)
|
27.23
(37.56)
|
| Week 140 |
1.57
(0.00)
|
20.66
(18.10)
|
| Week 144 |
1.57
(0.00)
|
16.82
(16.16)
|
| Week 148 |
2.04
(1.25)
|
17.10
(11.33)
|
| Week 152 |
1.57
(0.00)
|
16.62
(13.75)
|
| Week 156 |
2.34
(1.72)
|
12.67
(5.73)
|
| Week 160 |
1.96
(0.80)
|
11.15
(5.12)
|
| Week 164 |
1.57
(0.00)
|
12.84
(6.93)
|
| Week 168 |
1.57
(0.00)
|
13.30
(8.89)
|
| Week 172 |
1.57
(0.00)
|
13.89
(6.94)
|
| Week 176 |
1.57
(0.00)
|
15.11
(7.16)
|
| Week 180 |
1.57
(0.00)
|
13.34
(6.68)
|
| Week 184 |
15.24
(9.91)
|
|
| Week 188 |
13.96
(9.74)
|
|
| Week 192 |
16.71
(13.15)
|
|
| Week 196 |
14.34
(12.81)
|
|
| Week 200 |
18.55
(8.84)
|
|
| Week 204 |
18.24
(12.53)
|
|
| Week 208 |
9.95
(NA)
|
|
| Week 212 |
8.02
(NA)
|
|
| Week 216 |
6.45
(NA)
|
|
| Week 220 |
45.80
(NA)
|
|
| Week 224 |
34.30
(NA)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Number [participants] |
40
95.2%
|
37
90.2%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Number [participants] |
9
21.4%
|
7
17.1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Number [participants] |
0
0%
|
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 42 | 41 |
| Non serious Infections requiring IV treatment |
4
9.5%
|
1
2.4%
|
| Potential Opportunistic Infections |
5
11.9%
|
4
9.8%
|
| Injection Related Reactions |
2
4.8%
|
5
12.2%
|
| Anaphylaxis |
0
0%
|
0
0%
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 41 | 41 |
| Baseline |
5
11.9%
|
12
29.3%
|
| Post-Baseline |
2
4.8%
|
3
7.3%
|
| Title | Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 24, 48, and every 24 weeks thereafter of double-blind period; every 24 weeks for first 48 weeks of open-label extension period (up to approximately 7 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Drift in the anti-AQP4 antibody titer cell-based assay over time confounded longitudinal assessment of anti-AQP4 antibody titers and therefore these results cannot be reported. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 0 | 0 |
| Title | Percentage of Blood Plasmablast Over Time |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 24, 48 and every 24 weeks thereafter of double-blind period (up to approximately 30 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The plasmablast assay lacked the sensitivity required to measure plasmablast levels at baseline in the majority of participants. Since most participants had plasmablast values below lower limit of quantitation (LLOQ) at baseline, longitudinal assessments could not be performed and therefore plasmablast results are not reported. |
| Arm/Group Title | Placebo + Baseline Treatment | Satralizumab + Baseline Treatment |
|---|---|---|
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 0 | 0 |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from SAF who received satralizumab were evaluated for this outcome measure. The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. Data was summarized together for this outcome measure. |
| Arm/Group Title | Satralizumab + Baseline Treatment |
|---|---|
| Arm/Group Description | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. Following the DB period all participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. At the CCOD, participants who had not experienced a relapse during the DB period were invited to continue satralizumab 120 mg SC injection (with or without baseline treatment at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. |
| Measure Participants | 41 |
| Number [percentage] |
41.5
|
Adverse Events
| Time Frame | Up to clinical cut-off date, 06 June 2018 (up to approximately 224 weeks). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The SAF included all randomized participants who had received at least 1 dose of satralizumab or placebo. | |||||||
| Arm/Group Title | Placebo + Baseline Treatment, DB Period | Satralizumab + Baseline Treatment, DB Period | Placebo, Then Satralizumab, OLE Period | Satralizumab, Then Satralizumab, OLE Period | ||||
| Arm/Group Description | Participants received matching placebo, subcutaneous (SC) at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse or treated relapse in addition to baseline treatment. | Participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter throughout the DB period up to protocol-defined relapse or treated relapse in addition to baseline treatment. | Following placebo treatment in the DB period participants received satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). | Following satralizumab in the DB period participants continued satralizumab 120 mg SC injection (with or without baseline treatment) at Weeks 0, 2 and 4, and Q4W thereafter up to the CCOD. | ||||
All Cause Mortality |
||||||||
| Placebo + Baseline Treatment, DB Period | Satralizumab + Baseline Treatment, DB Period | Placebo, Then Satralizumab, OLE Period | Satralizumab, Then Satralizumab, OLE Period | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/41 (0%) | 0/24 (0%) | 0/18 (0%) | ||||
Serious Adverse Events |
||||||||
| Placebo + Baseline Treatment, DB Period | Satralizumab + Baseline Treatment, DB Period | Placebo, Then Satralizumab, OLE Period | Satralizumab, Then Satralizumab, OLE Period | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/42 (21.4%) | 7/41 (17.1%) | 6/24 (25%) | 5/18 (27.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia macrocytic | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Autoimmune thrombocytopenia | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Leukopenia | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Lymphopenia | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Eye disorders | ||||||||
| Glaucoma | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Retinal vein thrombosis | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| General disorders | ||||||||
| Gait disturbance | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Infections and infestations | ||||||||
| Appendicitis | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Cellulitis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Endocarditis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Enterocolitis infectious | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Escherichia sepsis | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Hepatitis E | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Influenza | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pneumonia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Urinary tract infection | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Urosepsis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Femur fracture | 0/42 (0%) | 0 | 1/41 (2.4%) | 2 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Spinal compression fracture | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 2 |
| Upper limb fracture | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Systemic lupus erythematosus | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Breast cancer | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Hepatic cancer | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 2 | 0/18 (0%) | 0 |
| Parkinsonism | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Tension headache | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||||||||
| Suicide attempt | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Dysuria | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Cervical dysplasia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Uterine polyp | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo + Baseline Treatment, DB Period | Satralizumab + Baseline Treatment, DB Period | Placebo, Then Satralizumab, OLE Period | Satralizumab, Then Satralizumab, OLE Period | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/42 (85.7%) | 33/41 (80.5%) | 23/24 (95.8%) | 16/18 (88.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 5/42 (11.9%) | 8 | 3/41 (7.3%) | 3 | 3/24 (12.5%) | 3 | 5/18 (27.8%) | 6 |
| Iron deficiency anaemia | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 3 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Leukopenia | 4/42 (9.5%) | 12 | 6/41 (14.6%) | 10 | 5/24 (20.8%) | 5 | 3/18 (16.7%) | 8 |
| Lymphopenia | 4/42 (9.5%) | 9 | 3/41 (7.3%) | 7 | 1/24 (4.2%) | 1 | 3/18 (16.7%) | 9 |
| Neutropenia | 2/42 (4.8%) | 3 | 2/41 (4.9%) | 3 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 2 |
| Hypofibrinogenaemia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Polycythaemia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Cardiac disorders | ||||||||
| Angina pectoris | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Bradycardia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Palpitations | 1/42 (2.4%) | 2 | 0/41 (0%) | 0 | 2/24 (8.3%) | 3 | 0/18 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||
| Left ventricle outflow tract obstruction | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Ear and labyrinth disorders | ||||||||
| Vertigo | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 5 |
| Eye disorders | ||||||||
| Conjunctival haemorrhage | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 4 | 2/18 (11.1%) | 2 |
| Blepharitis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blepharospasm | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Cataract | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Conjunctival deposit | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Conjunctivitis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Dry eye | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Eye pruritus | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Glaucoma | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Retinal haemorrhage | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 3/24 (12.5%) | 3 | 0/18 (0%) | 0 |
| Constipation | 7/42 (16.7%) | 8 | 2/41 (4.9%) | 2 | 4/24 (16.7%) | 7 | 1/18 (5.6%) | 2 |
| Dental caries | 2/42 (4.8%) | 2 | 2/41 (4.9%) | 2 | 4/24 (16.7%) | 5 | 1/18 (5.6%) | 1 |
| Diarrhoea | 3/42 (7.1%) | 3 | 1/41 (2.4%) | 3 | 2/24 (8.3%) | 2 | 3/18 (16.7%) | 4 |
| Gastritis | 0/42 (0%) | 0 | 4/41 (9.8%) | 4 | 2/24 (8.3%) | 2 | 2/18 (11.1%) | 2 |
| Nausea | 3/42 (7.1%) | 3 | 3/41 (7.3%) | 3 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Toothache | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 4/24 (16.7%) | 5 | 0/18 (0%) | 0 |
| Abdominal distension | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Abdominal pain | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Dyspepsia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Large intestine polyp | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pancreatitis acute | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Plicated tongue | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| General disorders | ||||||||
| Fatigue | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 3/24 (12.5%) | 3 | 1/18 (5.6%) | 1 |
| Pyrexia | 5/42 (11.9%) | 7 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Chest discomfort | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Chills | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Feeling abnormal | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Feeling hot | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Malaise | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Non-cardiac chest pain | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Oedema peripheral | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hepatobiliary disorders | ||||||||
| Hepatic function abnormal | 1/42 (2.4%) | 2 | 0/41 (0%) | 0 | 1/24 (4.2%) | 2 | 1/18 (5.6%) | 1 |
| Hypertransaminasaemia | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 2 |
| Infections and infestations | ||||||||
| Cystitis | 4/42 (9.5%) | 6 | 3/41 (7.3%) | 4 | 2/24 (8.3%) | 2 | 4/18 (22.2%) | 5 |
| Herpes zoster | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Influenza | 4/42 (9.5%) | 5 | 0/41 (0%) | 0 | 2/24 (8.3%) | 3 | 1/18 (5.6%) | 1 |
| Nasopharyngitis | 7/42 (16.7%) | 13 | 10/41 (24.4%) | 22 | 10/24 (41.7%) | 35 | 2/18 (11.1%) | 5 |
| Oral herpes | 3/42 (7.1%) | 19 | 2/41 (4.9%) | 6 | 2/24 (8.3%) | 3 | 1/18 (5.6%) | 3 |
| Pharyngitis | 3/42 (7.1%) | 10 | 4/41 (9.8%) | 6 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Rhinitis | 0/42 (0%) | 0 | 3/41 (7.3%) | 4 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Sinusitis | 0/42 (0%) | 0 | 3/41 (7.3%) | 4 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Upper respiratory tract infection | 6/42 (14.3%) | 11 | 10/41 (24.4%) | 26 | 6/24 (25%) | 7 | 5/18 (27.8%) | 18 |
| Urinary tract infection | 7/42 (16.7%) | 7 | 6/41 (14.6%) | 8 | 7/24 (29.2%) | 11 | 2/18 (11.1%) | 11 |
| Bacteriuria | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Cellulitis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hordeolum | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Onychomycosis | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Oral candidiasis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Otitis externa | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Periodontitis | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 5 | 1/18 (5.6%) | 1 |
| Pneumonia | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pyelonephritis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Respiratory tract infection | 1/42 (2.4%) | 2 | 0/41 (0%) | 0 | 1/24 (4.2%) | 3 | 1/18 (5.6%) | 1 |
| Viral upper respiratory tract infection | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Fall | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Ligament sprain | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 3/24 (12.5%) | 3 | 0/18 (0%) | 0 |
| Thermal burn | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Arthropod sting | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Compression fracture | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Contusion | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Excoriation | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Joint injury | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lower limb fracture | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pelvic fracture | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Wound | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 2 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 2 |
| Investigations | ||||||||
| Aspartate aminotransferase increased | 3/42 (7.1%) | 4 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 3 | 1/18 (5.6%) | 1 |
| Alanine aminotransferase increased | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Blood alkaline phosphatase increased | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood creatine phosphokinase increased | 2/42 (4.8%) | 3 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Blood fibrinogen decreased | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Blood fibrinogen increased | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Blood pressure increased | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood urine | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Complement factor decreased | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Gamma-glutamyltransferase increased | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Low density lipoprotein increased | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lymphocyte count decreased | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Neutrophil count decreased | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Platelet count decreased | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Protein urine present | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Prothrombin time prolonged | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Serum ferritin decreased | 3/42 (7.1%) | 3 | 1/41 (2.4%) | 2 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Urobilinogen urine increased | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Weight decreased | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Weight increased | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| White blood cell count decreased | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Dyslipidaemia | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Hypercholesterolaemia | 5/42 (11.9%) | 5 | 4/41 (9.8%) | 10 | 3/24 (12.5%) | 4 | 1/18 (5.6%) | 7 |
| Hyperlipidaemia | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Dehydration | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hyperglycaemia | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Iron deficiency | 0/42 (0%) | 0 | 2/41 (4.9%) | 3 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/42 (0%) | 0 | 4/41 (9.8%) | 4 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Back pain | 5/42 (11.9%) | 9 | 4/41 (9.8%) | 4 | 2/24 (8.3%) | 2 | 3/18 (16.7%) | 3 |
| Myalgia | 2/42 (4.8%) | 2 | 1/41 (2.4%) | 5 | 3/24 (12.5%) | 4 | 1/18 (5.6%) | 6 |
| Pain in extremity | 3/42 (7.1%) | 3 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Intervertebral disc protrusion | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Muscle spasms | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Musculoskeletal stiffness | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Myopathy toxic | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Neck pain | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Osteoarthritis | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Spinal osteoarthritis | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Spinal pain | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Nervous system disorders | ||||||||
| Dizziness | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 3 | 3/24 (12.5%) | 3 | 0/18 (0%) | 0 |
| Headache | 4/42 (9.5%) | 6 | 10/41 (24.4%) | 28 | 4/24 (16.7%) | 5 | 7/18 (38.9%) | 11 |
| Epilepsy | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypoaesthesia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Intercostal neuralgia | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Muscle spasticity | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||||||||
| Anxiety | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 3 |
| Depression | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Insomnia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 2/18 (11.1%) | 2 |
| Panic disorder | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Renal and urinary disorders | ||||||||
| Leukocyturia | 3/42 (7.1%) | 3 | 2/41 (4.9%) | 2 | 2/24 (8.3%) | 3 | 0/18 (0%) | 0 |
| Haematuria | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Nephrolithiasis | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Reproductive system and breast disorders | ||||||||
| Amenorrhoea | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/42 (4.8%) | 3 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Epistaxis | 0/42 (0%) | 0 | 2/41 (4.9%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Oropharyngeal pain | 1/42 (2.4%) | 1 | 3/41 (7.3%) | 4 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Pharyngeal erythema | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Rhinorrhoea | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 2 |
| Upper respiratory tract inflammation | 0/42 (0%) | 0 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Eczema | 1/42 (2.4%) | 1 | 2/41 (4.9%) | 2 | 3/24 (12.5%) | 3 | 0/18 (0%) | 0 |
| Urticaria | 0/42 (0%) | 0 | 3/41 (7.3%) | 3 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Acne | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Alopecia | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Erythema | 1/42 (2.4%) | 1 | 1/41 (2.4%) | 1 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Rash | 2/42 (4.8%) | 2 | 0/41 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 3 |
| Rash pruritic | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Vascular disorders | ||||||||
| Flushing | 0/42 (0%) | 0 | 1/41 (2.4%) | 1 | 2/24 (8.3%) | 2 | 2/18 (11.1%) | 2 |
| Hypertension | 0/42 (0%) | 0 | 3/41 (7.3%) | 4 | 1/24 (4.2%) | 2 | 2/18 (11.1%) | 4 |
| Hypotension | 1/42 (2.4%) | 1 | 0/41 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02028884
Other Study ID Numbers:
- BN40898
- 2013-003752-21
- SA-307JG
First Posted:
Jan 7, 2014
Last Update Posted:
Feb 17, 2022
Last Verified:
Jan 1, 2022