Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001088-26 | EudraCT Number |
Not provided
Not provided
Study has proved infeasible to recruit in sufficient numbers. There are insufficient eligible patients presenting to sites.
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| Name | Class |
|---|---|
| Chugai Pharmaceutical Co. | UNKNOWN |
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Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)
Neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD) are severe demyelinating inflammatory autoimmune neurological disorders. The estimated global pooled prevalence of NMOSD is 1.82 per 100 000 people (Etemadifar et al. 2015). The disorder is characterized by inflammatory lesions in the optic nerve, spinal cord, brainstem, and cerebrum; and clinically by optic neuritis (ON) and/or transverse myelitis causing potentially severe motor and sensory impairment, bladder dysfunction, vision loss, pain, and other debilitating symptoms (Wingerchuk et al. 2015). Recovery is variable, and inflammatory attacks often result in permanent disability. Untreated, the risks of severe disability or death are substantial (Jarius et al. 2014).
NMOSD is radiologically and prognostically distinct from multiple sclerosis (MS), and has a pathophysiology unresponsive to typical MS treatment (Weinshenker 2007; Oh, and Levy et al. 2012).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: treatment-naïve NMOSD patients | Experimental | Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised). |
|
| Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTX | Experimental | Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satralizumab 120 mg | Drug | Satralizumab 120 mg will be administered as monotherapy (SC) in the abdominal or femoral region at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Weeks 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Relapse-Free Participants | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | Up to 14 months |
| Annualized Relapse Rate (ARR) | The ARR was calculated descriptively by dividing the total number of relapses for all participants by the total years of drug exposure. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | Up to 14 months |
| Time to First Relapse (TFR) | TFR was defined as the time from first dose of satralizumab to the first occurrence of relapse. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | Up to 14 months |
| Percentage of Participants Hospitalized Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the occurrence of hospitalization. | Up to 14 months |
| Percentage of Participants Using Corticosteroids Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on use of corticosteroids. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans | MRI was used to monitor central nervous system (CNS) lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. LETM=longitudinally extensive transverse myelitis. Stm=subcortical temporal medial. Count of T2-weighted FLAIR hyperintense lesions (including new and enlarging) were distributed across the following regions: cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum. |
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Inclusion criteria
Exclusion criteria Exclusion criteria for both the cohorts
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| National Cancer Center |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 4 participants with neuromyelitis optica spectrum disorder (NMOSD) were enrolled in 'Cohort 2: Inadequate Responders to Previous Rituximab (RTX) Treatment' to receive satralizumab. No participants were enrolled in 'Cohort 1: Treatment-naïve Participants' due to early study termination.
Participants took part in this study at 3 investigative sites in 3 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 2: Inadequate Responders to Previous Rituximab (RTX) Treatment | Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all enrolled participants who received any dose of satralizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 2: Inadequate Responders to Previous RTX Treatment | Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Relapse-Free Participants | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
Up to 14 months
Safety population included all enrolled participants who received any dose of satralizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 2: Inadequate Responders to Previous RTX Treatment | Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2021 | Oct 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000655944 | satralizumab |
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|
| Up to 14 months |
| Percentage of Participants in Need of Rescue Therapy Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need of rescue therapy. Rescue therapy for clinical relapse included pulse intravenous (IV) corticosteroids, oral corticosteroids for tapering, intravenous immunoglobulin (IVIG) and/or apheresis (including plasma exchange and plasmapheresis). | Up to 14 months |
| Percentage of Participants in Need of Plasma Exchange Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need for plasma exchange. | Up to 14 months |
| Percentage of Participants With Residual Disability Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | Up to 14 months |
| Change From Baseline in Expanded Disability Status Scale (EDSS) Score | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. A negative change from baseline indicates improvement. | Up to Week 36 |
| Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 12 Weeks | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. | Up to 12 weeks |
| Change From Baseline in the Symbol Digital Modalities Test (SDMT) | SDMT testing was to detect impairment of key neurocognitive functions that underlie many substitution tasks, including sustained attention, visual scanning, and recent memory. The test consisted of a sequence of 110 symbols displayed in a maximum 90 seconds and a reference key legend with 9 symbols in a given order and their respective matching digits from 1 to 9. The test measures the speed (number of correct paired responses) to pair abstract symbols with specific digits in 90 seconds time. The score is the number of correctly paired items in 90 seconds with a maximum score of 110 and minimum of 0. Higher scores indicate improvement. | Baseline, Week 24 |
| Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts | Best corrected high-contrast (100%) and low-contrast (2.5%) visual acuities were measured at distances of both 4 and 1 meters with the appropriate eye charts. Each eye was tested individually. No visual acuities were obtained with both eyes open. The participants read the charts from left to right starting with the top line (largest letters). The participants proceeded to each lower line until he/she could not see the letters. The total number of letters read correctly were recorded for each eye. Visual acuity was measured before any drops are instilled into the eye and before OCT assessments. | Baseline and Week 24 |
| Change in Visual Functioning Questionnaire -25 (VFQ-25) | The National Eye institute (NEI) VFQ-25 captures a participants's perception of vision-related functioning and vision-related quality of life. The core measures include 25 items that comprise 11 vision-related subscales and one item on general health. The NEI VFQ-25 also included an appendix of additional items that was used to expand the scales up to 39 total items. The composite score and the subscale scores range from 0 to 100, with higher scores indicating better vision-related functioning. | At Week 24 |
| Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. | Up to 24 weeks |
| Weeks 4, 8, 12 and 24 |
| Volume of T2-weighted FLAIR Hyperintense Lesions Assessed Using MRI Scans | MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. | Baseline, Week 12 |
| Number of Participants With Contrast-enhancing T1-weighted Lesions (CEL) Assessed Using MRI Scans | MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. | Basline, Weeks 4, and 12 |
| Number of Participants With Diffusion Abnormalities, Microbleeds and Cerebral Perfusion Alterations Assessed Using MRI Scans | Up to 14 Months |
| Number of Participants With Global and Regional Brain Volume Loss Assessed Using MRI Scans | Up to 14 Months |
| Number of Participants With New and Persisting Short T1 Inversion Recovery (STIR)/ Proton Density (PD) Hyperintense Lesions and T1-weighted Contrast Enhancement Assessed Using MRI Scans | Up to 14 months |
| Quantitative T1 Mapping (Magnetization Prepared Rapid Gradient Echo Sequence [MP2RAGE]) Assessed Using MRI Scans | Up to 14 months |
| T2*/R* Ratio for Iron Concentration Estimation Assessed Using MRI Scans | Up to 14 months |
| Quantitative Diffusion/ Diffusion Tensor Imaging (DTI) Assessed Using MRI Scans | Up to 14 months |
| Change in the Retinal Nerve Fiber Layer (RNFL) Thickness Assessed Using Optical Coherence Tomography (OCT) | Up to 14 months |
| Change in the Ganglion Cell Plus Inner Plexiform (GCIP) Layer Thickness Assessed Using OCT | Up to 14 months |
| Concentration of Satralizumab in Cerebrospinal Fluid (CSF) and Serum | Baseline and Week 12 |
| Number of Participants With Anti-satralizumab Antibodies | Up to 14 months |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE 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. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. An AESI included drug induced liver injury and suspected transmission of infectious agent via medicinal products. | Up to 14 months |
| Goyang-si |
| 10408 |
| South Korea |
| Ondokuz Mayis University School of Medicine | Samsun | 55239 | Turkey (Türkiye) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Annualized Relapse Rate (ARR) | The ARR was calculated descriptively by dividing the total number of relapses for all participants by the total years of drug exposure. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | 95% Confidence Interval | relapses per participant-year | Up to 14 months |
|
|
|
| Primary | Time to First Relapse (TFR) | TFR was defined as the time from first dose of satralizumab to the first occurrence of relapse. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Median | 95% Confidence Interval | weeks | Up to 14 months |
|
|
|
| Primary | Percentage of Participants Hospitalized Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the occurrence of hospitalization. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
|
|
| Primary | Percentage of Participants Using Corticosteroids Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on use of corticosteroids. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
|
|
| Primary | Percentage of Participants in Need of Rescue Therapy Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need of rescue therapy. Rescue therapy for clinical relapse included pulse intravenous (IV) corticosteroids, oral corticosteroids for tapering, intravenous immunoglobulin (IVIG) and/or apheresis (including plasma exchange and plasmapheresis). | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
|
|
| Primary | Percentage of Participants in Need of Plasma Exchange Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need for plasma exchange. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
|
|
| Primary | Percentage of Participants With Residual Disability Due to Relapse | Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur <31 days following the onset of a relapse were considered part of the same relapse. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | percentage of participants | Up to 14 months |
|
|
|
| Primary | Change From Baseline in Expanded Disability Status Scale (EDSS) Score | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. A negative change from baseline indicates improvement. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Mean | Standard Deviation | score on a scale | Up to Week 36 |
|
|
|
| Primary | Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 12 Weeks | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Median | 95% Confidence Interval | weeks | Up to 12 weeks |
|
|
|
| Primary | Change From Baseline in the Symbol Digital Modalities Test (SDMT) | SDMT testing was to detect impairment of key neurocognitive functions that underlie many substitution tasks, including sustained attention, visual scanning, and recent memory. The test consisted of a sequence of 110 symbols displayed in a maximum 90 seconds and a reference key legend with 9 symbols in a given order and their respective matching digits from 1 to 9. The test measures the speed (number of correct paired responses) to pair abstract symbols with specific digits in 90 seconds time. The score is the number of correctly paired items in 90 seconds with a maximum score of 110 and minimum of 0. Higher scores indicate improvement. | ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
|
|
|
| Primary | Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts | Best corrected high-contrast (100%) and low-contrast (2.5%) visual acuities were measured at distances of both 4 and 1 meters with the appropriate eye charts. Each eye was tested individually. No visual acuities were obtained with both eyes open. The participants read the charts from left to right starting with the top line (largest letters). The participants proceeded to each lower line until he/she could not see the letters. The total number of letters read correctly were recorded for each eye. Visual acuity was measured before any drops are instilled into the eye and before OCT assessments. | ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Number | Letters correct | Baseline and Week 24 |
|
|
|
| Primary | Change in Visual Functioning Questionnaire -25 (VFQ-25) | The National Eye institute (NEI) VFQ-25 captures a participants's perception of vision-related functioning and vision-related quality of life. The core measures include 25 items that comprise 11 vision-related subscales and one item on general health. The NEI VFQ-25 also included an appendix of additional items that was used to expand the scales up to 39 total items. The composite score and the subscale scores range from 0 to 100, with higher scores indicating better vision-related functioning. | ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | At Week 24 |
|
|
|
| Secondary | Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans | MRI was used to monitor central nervous system (CNS) lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. LETM=longitudinally extensive transverse myelitis. Stm=subcortical temporal medial. Count of T2-weighted FLAIR hyperintense lesions (including new and enlarging) were distributed across the following regions: cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Number | number of lesions | Weeks 4, 8, 12 and 24 | lesion | lesion |
|
|
|
| Secondary | Volume of T2-weighted FLAIR Hyperintense Lesions Assessed Using MRI Scans | MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. | ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Median | Standard Deviation | milliliter (mL) | Baseline, Week 12 | lesion | lesion |
|
|
|
| Secondary | Number of Participants With Contrast-enhancing T1-weighted Lesions (CEL) Assessed Using MRI Scans | MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Count of Participants | Participants | Basline, Weeks 4, and 12 |
|
|
|
| Secondary | Number of Participants With Diffusion Abnormalities, Microbleeds and Cerebral Perfusion Alterations Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 Months |
|
|
| Secondary | Number of Participants With Global and Regional Brain Volume Loss Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 Months |
|
|
| Secondary | Number of Participants With New and Persisting Short T1 Inversion Recovery (STIR)/ Proton Density (PD) Hyperintense Lesions and T1-weighted Contrast Enhancement Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Quantitative T1 Mapping (Magnetization Prepared Rapid Gradient Echo Sequence [MP2RAGE]) Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | T2*/R* Ratio for Iron Concentration Estimation Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Quantitative Diffusion/ Diffusion Tensor Imaging (DTI) Assessed Using MRI Scans | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Change in the Retinal Nerve Fiber Layer (RNFL) Thickness Assessed Using Optical Coherence Tomography (OCT) | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Change in the Ganglion Cell Plus Inner Plexiform (GCIP) Layer Thickness Assessed Using OCT | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Concentration of Satralizumab in Cerebrospinal Fluid (CSF) and Serum | ITT population included all enrolled participants who received any dose of satralizumab. Data for this CSF concentartion was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/litre (ng/L) | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Anti-satralizumab Antibodies | Data for this outcome measure was not collected and analyzed as planned as the study was terminated per sponsor's decision. | Posted | Up to 14 months |
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE 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. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. An AESI included drug induced liver injury and suspected transmission of infectious agent via medicinal products. | Safety population included all enrolled participants who received any dose of satralizumab. | Posted | Count of Participants | Participants | Up to 14 months |
|
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| Primary | Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. | ITT population included all enrolled participants who received any dose of satralizumab. | Posted | Median | 95% Confidence Interval | weeks | Up to 24 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigators are 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.
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| Left Low Contrast |
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| Week 4: Hyperintense Lesion |
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| Week 8: Hyperintense Lesion |
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| Week 12: Hyperintense Lesion |
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| Baseline: Hyperintense Letm Lesion |
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| Week 4: Hyperintense Letm Lesion |
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| Week 8: Hyperintense Letm Lesion |
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| Week 12: Hyperintense Letm Lesion |
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| Baseline: Hyperintense Stm Lesion |
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| Week 4: Hyperintense Stm Lesion |
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| Week 8: Hyperintense Stm Lesion |
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| Week 12: Hyperintense Stm Lesion |
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| Week 24: Hyperintense Lesion |
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| Week 24: Hyperintense Letm Lesion |
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| Week 24: Hyperintense Stm Lesion |
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| Title | Measurements |
|---|
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