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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002937-31 | EudraCT Number |
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The study was terminated earlier as the study sponsor collected sufficient data to perform all analyses as per pre-specified endpoints in the study protocol.
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This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.
The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period. |
|
| Substudy Group 1 | Active Comparator | At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration |
|
| Substudy Group 2 | Experimental | At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab will be administered via IV infusion as specified throughout the treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS) | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits for a minimum of 24 weeks/48 weeks. | Baseline up to 4 years |
| Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS | CDI is defined as an improvement of ≥1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | At Weeks 24 and 48 during Year 1 |
| Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Relapse Free | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | Week 192 |
| Percentage of Participants With No Evidence of Protocol Defined Disease Activity |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions Related to General Health:
Exclusions Related to Medications:
Exclusion related to Shorter Infusion Substudy:
- Any previous serious IRRs experienced with ocrelizumab treatment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| Palo Alto Medical Foundation Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42328798 | Derived | Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/ene.70628. | |
| 40781066 |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical 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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The efficacy analyses were performed on the main study cohort enrolled as per original study protocol, and safety analyses on all enrolled participants.
A prospective, multicenter, open-label, single-arm effectiveness and safety study enrolled 1225 eligible treatment-naive patients with early stage RMSR. The study consisted of screening period up 4 weeks and open-label treatment with ocrelizumab period up to 192 week.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study - Ocrelizumab | Ocrelizumab was administered intravenously (IV) as two 300-milligram (mg) infusions on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period. |
| FG001 | Substudy - Conventional Infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2021 | Apr 26, 2024 |
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| Year 1 (Weeks 24 and 48) |
| Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS | CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | At Weeks 48, 72 and 96 during Year 2 |
| Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 2, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. | Year 2 (Weeks 72 and 96) |
| Percentage of Participants With 24-Week and 48-Week CDI at Year 4, as Measured Using EDSS | CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | At Weeks 144, 168 and 192 during Year 4 |
| Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 4, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. | Year 4 (Weeks 168 and 192) |
| Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS | Year 1 (Week 48) |
| Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS | Year 2 (Week 96) |
| Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 3, As Measured Using EDSS | Year 3 |
| Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 4, As Measured Using EDSS | Year 4 |
| Mean Change From Baseline in EDSS Score at Week 24 | From Baseline to Week 24 |
| Mean Change From Baseline in EDSS Score at Week 48 | From Baseline to Week 48 |
| Mean Change From Baseline in EDSS Score at Week 72 | From Baseline to Week 72 |
| Mean Change From Baseline in EDSS Score at Week 96 | Baseline, Week 96 |
| Mean Change From Baseline in EDSS Score at Week 120 | Baseline, Week 120 |
| Mean Change From Baseline in EDSS Score at Week 144 | Baseline, Week 144 |
| Mean Change From Baseline in EDSS Score at Week 168 | Baseline, Week 168 |
| Mean Change From Baseline in EDSS Score at Week 192 | Baseline, Week 192 |
| Percentage of Participants Without Protocol-Defined Event of Disease Activity | Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan. | Baseline up to 4 years |
| Percentage of Participants Without Relapse | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | Baseline up to 4 years |
| Annualized Relapse Rate | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. The adjusted annualized relapse rate is reported which is: Adjusted by age at disease diagnosis, Baseline EDSS, Presence of T1 Gd-enhanced lesion at screening and Presence of relapses in the last year prior to enrollment. Log-transformed exposure time is included as an offset variable. The report contains data up to week 192 of the treatment period of each individual participant. | Baseline up to 4 years |
| Sub Study: Number of Participants With IRRs Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy | Week 24 through Week 144 |
Protocol-defined disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8. (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan. Event-free rate |
| Weeks 96, 144, 192 |
| Percentage of Participants Without Protocol-defined Event of Evidence of Progression (NEP) | NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20 percent [%] increase from baseline in timed 25 Foot Walk Test [T25FWT]; 20% increase from baseline in timed 9 hole peg test [9HPT]). CDP will be assessed using EDSS. | Weeks 96, 192 |
| Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD) | NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion. CDP will be assessed using EDSS. Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | Weeks 96, 192 |
| Secondary: Change From Baseline in Multiple Sclerosis Functional Composite Score (MSFC) Total | MSFC combines the following: Timed 25 Foot Walk Test [T25FWT] for leg function &ambulation measured in seconds (sec). The longer it takes to walk, higher the score indicating deterioration; 9 Hole Peg Test [9HPT] for arm & handf unction measured in sec. Higher score=more time taken to complete test indicating deterioration. Paced Auditory Serial Addition Test [PASAT] for cognitive function (score range: 0-60, higher score=better cognitive processing speed). MSFC composite={[Average(1/9-HPT)-Baseline Mean(1/9-HPT)/Baseline Std Dev(1/9-HPT)]+[-(Average T25FWT-Baseline Mean T25FWT)/Baseline Std-Dev T25FWT]+[(PASAT-3-BaselineMean PASAT-3)/Baseline Std Dev PASAT-3]}/ 3.0. MSFC is based on the concept that scores for these 3 dimensions are combined to create a single score to detect change over time in a group of MS patients. Higher composite score=better overall function. Lower score=worse overall function. Higher mean change in total MSFC score=functional improvement at cohort level. | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
| Change From Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score. | The change in the mean score of T25FW is reported below. The time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. Higher times indicate worse performance and greater impairment. Subsequently, the lower the mean change in the score over time, the better performance. | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
| Change From Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score | The mean change in 9 Hole Peg Test (9HPT)-score is reported. Participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. Both the dominant and non-dominant hands are tested twice (two consecutive trials for each hand). The participants are required to complete two successful trials for each hand. The amount of time (in seconds) required to place and remove all nine pegs is recorded for each trial. The number of seconds it takes to complete the test, the higher raw scores, which indicates deterioration. The lower mean change in the score over time, the better the performance. | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
| Change From Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score | Mean change in the Paced Auditory Serial Addition Test [PASAT] score is reported. PASAT measures cognitive function. A total of 60 single digit numbers are presented by an audiotape/CD-rom at a constant rate in every 3 seconds (PASAT-3). Participants are required to add each new number to the one immediately before it. Due to the relative complexity of this test, a practice trial with a set of 10 numbers should be performed before the original test. Participants are allowed up to 3 practice trials. Two sets of numbers (forms A & B) are developed to be used alternatively in every visit to minimize memorizing. The number of correct answers is recorded. The PASAT score ranges from 0 to 60, with higher values representing a better outcome in cognitive processing speed. Subsequently, higher values in mean changes from baseline over the study time indicate improvement in cognitive function. | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
| Change From Baseline in Cognitive Performance as Measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) - Symbol Digits Modalities Test (SDMT) | BICAMS is assessing cognitive processing speed and verbal and visual memory. SDMT assesses processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 second time span. The higher the results, the better processing speed/working memory. | Baseline, Weeks 48, 96, 144, 192 |
| Change From Baseline in Cognitive Performance as Measured by BICAMS -California Verbal Learning Test-II (CVLT-II) | BICAMS assesses cognitive processing speed and verbal and visual memory. The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. The maximum possible score is 80 and a minimum is 0. A higher score indicated better recall. | Baseline, Weeks 48, 96, 144, 192 |
| Change From Baseline in Cognitive Performance as Measured by BICAMS - Brief Visuospatial Memory Test-Revised (BVMT-R) | BICAMS assesses cognitive processing speed and verbal and visual memory. BVMT-R assesses visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory. | Baseline, Weeks 48, 96, 144, 192 |
| Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI | Number of Lesions are categorized as followed: 1, 2, 3, >1, >3 | Weeks 24, 48, 96, 144, 192 |
| Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI | Number of Lesions are categorized as followed: 1, 2, 3, >1 | Baseline, Weeks 24, 48, 96, 144, 192 |
| Change From Baseline in Total T1 Hypointense Lesion Volume as Detected by Brain MRI | Baseline, Weeks 48, 96, 144, 192 |
| Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI | Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI was measured for its volumes. | Baseline, Weeks 8, 24, 48, 96, 144, 192 |
| Change From Baseline in Brain Volume as Detected by Brain MRI | Percentage change from Normalized brain volume in cm3 (cubic centimeter)values are reported | From Baseline to Weeks 24, 48, 96, 144, 192 |
| Percentage of Participants Without Treatment Discontinuation | Baseline up to 4 years |
| Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score | WPAI scale measures impact of health problems on work productivity and regular activities: Absenteeism (Work Time Missed) measuring % of work time missed due to health issues; Presenteeism:Calculated as the percentage of impairment while working due to health problems. Overall Work Impairment:Calculated by combining absenteeism and presenteeism using the formula:Overall Work Impairment=Absenteeism+(1-Absenteeism)×Presenteeism Overall Work Impairment=Absenteeism+(1-Absenteeism)×Presenteeism This formula accounts for both the time missed and the reduced productivity while at work. Activity Impairment: Calculated as the percentage of impairment in regular activities outside of work. Range: Each component is scored as 0%-100%). Higher % indicate greater impairment and worse outcomes. | Baseline, Weeks 24, 48, 96, 120, 144, 192 |
| SymptoMScreen Composite Score | The SMSS consists of 12 items which are assessed on a seven-point Likert scale that ranges from 0 (not at all affected) to 6 (total limitation) [7]. The total score ranges from 0 to 72, with higher scores indicating more severe symptom endorsement. | Baseline, Weeks 24, 48, 96, 144, 192 |
| Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score | The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a questionnaire to examine the impact of multiple sclerosis (MS) on physical and psychological functioning from a patient's perspective, which includes 29 items self-reported measures associated with a physical scale and 9 items with a psychological scale. MSIS-29 scales are generated by summing items and it's ranging from 29-145'. The higher total MSIS-29 scores indicate a greater degree of disability. The mean change in MSIS-29 scores from baseline is reported. The decreasing values in the mean change from baseline indicate functional improvement from patients' perspective | Baseline, Weeks 24, 48, 96, 144, 192 |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 4 years |
| Substudy: Number of Participants With IRR Overall and by Dose at Randomization | From Week 24 to Week 144 |
| Substudy: Severity of IRRs | The number of participants with IRRs by most extreme intensity were reported (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 =life-threatening, grade 5 = fatal). Multiple IRRs in one participant are counted only once at the most extreme (highest) intensity observed. | From Week 24 to Week 144 |
| Substudy: Number of IRR Symptoms | From Week 24 to Week 144 |
| Substudy: IRRs Leading to Treatment Discontinuation | From Week 24 to Week 144 |
| Sunnyvale |
| California |
| 94086 |
| United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Advanced Neurology of Colorado, LLC | Fort Collins | Colorado | 80528 | United States |
| KI Health Partners, LLC; New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| University of South Florida - Bradenton | Tampa | Florida | 33612 | United States |
| Shepherd Center Inc. | Atlanta | Georgia | 30309 | United States |
| College Park Family Care Ctr | Overland Park | Kansas | 66212 | United States |
| The NeuroMedical Center | Baton Rouge | Louisiana | 70810 | United States |
| Maine Medical Center | Scarborough | Maine | 04074 | United States |
| University of Maryland Medical Center; Department of Neurology | Baltimore | Maryland | 21201 | United States |
| Neurology Center of New England | Foxborough | Massachusetts | 02035 | United States |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | United States |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | United States |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Island Neurological Associates, P.C. | Plainview | New York | 11803 | United States |
| Neurology Associates PA | Hickory | North Carolina | 28602 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40 | Cleveland | Ohio | 44195 | United States |
| Neurology Specialists, Inc | Dayton | Ohio | 45417 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Kane Hall Barry Neurology | Bedford | Texas | 76021 | United States |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders | Milwaukee | Wisconsin | 53215 | United States |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR | Buenos Aires | C1424 | Argentina |
| Hospital Churruca Visca | Buenos Aires | C1437JCP | Argentina |
| Fundacion Rosarina de Neurorehabilitacion | Rosario | S2000BZL | Argentina |
| Brain and Mind Centre | Camperdown | New South Wales | 2050 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| John Hunter Hospital | New Lambton | New South Wales | 2305 | Australia |
| Royal North Shore Hospital; Department of Neurology | St Leonards | New South Wales | 2065 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Box Hill Hospital; Department of Neurology | Box Hill | Victoria | 3128 | Australia |
| Austin Hospital; Department of Neurology | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital; Department of Neurology | Parkville | Victoria | 3050 | Australia |
| Perron Institute for Neurological and Translational Science | Nedlands | Western Australia | 6009 | Australia |
| Medizinische Universität Graz; Universitätsklinik für Neurologie | Graz | 8036 | Austria |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie | Innsbruck | 6020 | Austria |
| Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie | Salzburg | 5020 | Austria |
| Medizinische Universität Wien; Univ.Klinik fuer Neurologie | Vienna | 1090 | Austria |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Revalidatie en MS Centrum | Overpelt | 3900 | Belgium |
| Hospital das Clinicas - UFMG | Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-010 | Brazil |
| Shat Np Sveti Naum; 3Rd Clinic of Neurology | Sofia | 1113 | Bulgaria |
| Multiprofile Hosp. for Active Treatment;National Cardiology Hosp. | Sofia | 1309 | Bulgaria |
| UMHAT Alexandrovska, EAD; Neurology | Sofia | 1431 | Bulgaria |
| UBC Hospital; Div of Neurology, Dept of Medicine | Vancouver | British Columbia | V6T 1Z3 | Canada |
| London Health Sciences Centre Uni Campus | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Clinique NeuroOutaouais | Gatineau | Quebec | J8Y 1W2 | Canada |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb. | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken | Aarhus N | 8200 | Denmark |
| Rigshospitalet; Neurologisk Klinik Glostrup | Glostrup Municipality | 2600 | Denmark |
| CHU de Besancon Hopital Jean Minjoz; Service de Neurologie | Besançon | 25030 | France |
| Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie | Bordeaux | 33076 | France |
| Hopital Pierre Wertheimer; Neurologie D | Bron | 69677 | France |
| CHU de Caen Hopital Cote de Nacre | Caen | 14033 | France |
| CHU Hopital Gabriel Montpied; Service de Neurologie | Clermont-Ferrand | 63003 | France |
| CH de Gonesse; Neurologie | Gonesse | 95503 | France |
| CHU de Grenoble; Neurologie | La Tronche | 38700 | France |
| Hopital Gui de Chauliac; Neurologie | Montpellier | 34295 | France |
| Hopital Central - CHU de Nancy; Service de Neurologie | Nancy | 54035 | France |
| Hôpital Guillaume et René Laënnec; Service Neurologie | Nantes | 44805 | France |
| Hôpital Pasteur; Service de Neurologie | Nice | 06002 | France |
| CHU de Nîmes Hopital Caremeau; Service de Neurologie | Nîmes | 30900 | France |
| Hôpital de Poissy; Service neurologie | Poissy | 78300 | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
| CHU de Rouen Hopital; Service de Neurologie | Rouen | 76031 | France |
| CHU de Strasbourg | Strasbourg | 67098 | France |
| Hopital Foch; Neurologie | Suresnes | 92151 | France |
| HIA de Toulon hôpital militaire; Neurologie | Toulon | 83041 | France |
| CHU toulouse - Hôpital Purpan; Departement de Neurologie | Toulouse | 31059 | France |
| CHRU - Hôpital Bretonneau; Neurologie | Tours | 37000 | France |
| Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie | Barsinghausen | 30890 | Germany |
| Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie | Berlin | 13347 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Bochum | 44791 | Germany |
| Studienzentrum Dr. Bischof GmbH | Böblingen | 71034 | Germany |
| Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf; Klinik für Neurologie | Düsseldorf | 40225 | Germany |
| NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich | Erbach/Odenwald | 64711 | Germany |
| Universitätsklinikum Essen (AöR); Klinik für Neurologie | Essen | 45147 | Germany |
| MultipEL Studies - Institut für klinische Studien | Hamburg | 22179 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische | Kassel | 34121 | Germany |
| Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie | Kiel | 24105 | Germany |
| Universitaetsklinikum Marburg; Klinik fuer Neurologie | Marburg | 35043 | Germany |
| Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum | München | 81675 | Germany |
| Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie | Münster | 48149 | Germany |
| Praxis Dr. med. Bergmann | Neuburg am Inn | 86633 | Germany |
| Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie | Seesen | 38723 | Germany |
| Universitätsklinikum Tübingen, Zentrum für Neurologie | Tübingen | 72076 | Germany |
| Semmelweis Egyetem AOK; Neurologiai Klinika | Budapest | 1083 | Hungary |
| Budapesti Uzsoki Utcai Kórház | Budapest | 1145 | Hungary |
| Jahn Ferenc Dél-Pesti Kórház | Budapest | 1204 | Hungary |
| VALEOMED Diagnosztikai Központ | Esztergom | 2500 | Hungary |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika | Szeged | 6725 | Hungary |
| A.O.U. Mater Domin; U.O. NEUROLOGIA | Catanzaro | Calabria | 88100 | Italy |
| A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche | Naples | Campania | 80131 | Italy |
| Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur | Naples | Campania | 80131 | Italy |
| Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica | Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera Sant'Andrea; UOC Neurologia | Rome | Lazio | 00189 | Italy |
| Irccs A.O.U.San Martino Ist; Dinogmi | Genoa | Liguria | 16132 | Italy |
| IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla | Milan | Lombardy | 20132 | Italy |
| Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari | Milan | Lombardy | 20133 | Italy |
| Ospedale Civile di Montichiari; Centro Sclerosi Multipla | Montichiari | Lombardy | 25018 | Italy |
| IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla | Pozzilli | Molise | 86077 | Italy |
| AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla | Catania | Sicily | 95123 | Italy |
| AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia | Palermo | Sicily | 90146 | Italy |
| AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA) | Florence | Tuscany | 50134 | Italy |
| Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia | Grosseto | Tuscany | 58100 | Italy |
| Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche | Siena | Tuscany | 53100 | Italy |
| Ibn Sina Hospital; Neurology Department | Kuwait City | 10002 | Kuwait |
| American University of Beirut - Medical Center | Beirut | 1107 2020 | Lebanon |
| Neurociencias Estudios Clinicos S.C. | Culiacán | Sinaloa | 80020 | Mexico |
| Hospital General de Mexico | Mexico | Tlaxcala | 06726 | Mexico |
| Unidad de investigacion en salud (UIS); Neurociencias | Mexico City | 14050 | Mexico |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| VU Medisch Centrum; Afdeling Neurologie | Amsterdam | 1081 HV | Netherlands |
| Groene Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Akershus universitetssykehus HF; Nevroklinikken S203 | Lørenskog | 1478 | Norway |
| Stavanger Universitetssykehus, Helse Stavanger HF | Stavanger | 4011 | Norway |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | 85-796 | Poland |
| COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny | Gdansk | 80-803 | Poland |
| Care Clinic | Katowice | 40-568 | Poland |
| Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o. | Krakow | 31-637 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin | 20-410 | Poland |
| Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie | Warsaw | 02-097 | Poland |
| Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Warsaw | 02-957 | Poland |
| Hospital Garcia de Orta; Servico de Neurologia | Almada | 2801-951 | Portugal |
| Hospital de Braga; Servico de Neurologia | Braga | 4710-243 | Portugal |
| HUC; Servico de Neurologia | Coimbra | 3000-075 | Portugal |
| Hospital Beatriz Angelo; Servico de Neurologia | Loures | 2674-514 | Portugal |
| Hospital Geral de Santo Antonio; Servico de Neurologia | Porto | 4099-001 | Portugal |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 11172 | Romania |
| Spitalul Clinic Judetean Sibiu | Sibiu | 550245 | Romania |
| Spitalul Clinic Judetean de Urgenta Mures | Târgu Mureş | 540136 | Romania |
| Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB | Bratislava | 813 69 | Slovakia |
| Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB | Bratislava | 826 06 | Slovakia |
| GB NeuroPRAKTIK, s.r.o | Nitra | 949 11 | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 917 75 | Slovakia |
| University Medical Centre; Neurology | Ljubljana | 1000 | Slovenia |
| University Medical Centre Maribor | Maribor | 2000 | Slovenia |
| Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital de Cruces; Servicio de Neurologia | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital General Universitario de Alicante; Servicio de NeurologÃa | Alicante | 03010 | Spain |
| Hospital del Mar; Servicio de Neurologia | Barcelona | 08003 | Spain |
| Hospital Vall d'Hebron; Servicio de NeurologÃa | Barcelona | 08035 | Spain |
| Hospital Universitario Puerta De Hierro Majadahonda; Servicio de NeurologÃa | Madrid | 28222 | Spain |
| Hospital General Universitario Morales Meseguer; Servicio de NeurologÃa | Murcia | 30008 | Spain |
| Sahlgrenska Sjukhuset; Neurology | Gothenburg | 413 45 | Sweden |
| Centralsjukhuset; Neurologi och rehabiliteringskliniken | Karlstad | 651 85 | Sweden |
| Centrum för Neurologi | Stockholm | 113 41 | Sweden |
| Universitätsspital Basel; Neurologie | Basel | 4031 | Switzerland |
| Inselspital Bern Medizin Neurologie; Neurologische Poliklinik | Bern | 3010 | Switzerland |
| Luzerner Kantonsspital Luzern Medizin Neurologie | Lucerne | 6004 | Switzerland |
| Ospedale Regionale di Lugano - Civico; Neurologia | Lugano | 6903 | Switzerland |
| Kantonsspital; Neurologische Klinik | Sankt Gallen | 9007 | Switzerland |
| Hacettepe University Medical Faculty; Neurology | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty; Departmant of Norology | Ankara | 06500 | Turkey (Türkiye) |
| Mustafa Kemal Ataturk UTF; Department of norology | Hatay | 31001 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty; Neurology | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali | Istanbul | 34098 | Turkey (Türkiye) |
| Istanbul Bilim Universty Medical Fac. | Istanbul | 34394 | Turkey (Türkiye) |
| Selcuk University Medical Faculty; Norology department | Istanbul | 42131 | Turkey (Türkiye) |
| Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | 55139 | Turkey (Türkiye) |
| Karadeniz Tecnical Uni. Med. Fac.; Neurology | Trabzon | 61080 | Turkey (Türkiye) |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Royal Free Hospital | London | NW3 2QS | United Kingdom |
| King'S College Hospital | London | SE5 9RS | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases | London | WC1N 3BG | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8BT | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | M6 8HD | United Kingdom |
| Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute | Swansea | SA6 6NL | United Kingdom |
| Derived |
| Garcia A, Rodriguez S, Dugast E, Lebrun-Frenay C, Thouvenot E, de Seze J, Le Page E, Vukusic S, Doghri I, Berger E, Casez O, Labauge P, Ruet A, Raposo C, Le Frere F, Nicot AB, Wiertlewski S, Gourraud PA, Michel L, Berthelot L, Laplaud DA. Durable B-Cell Impairment While Sparing IgA B Cells After Ocrelizumab Therapy in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Nov;12(11):2271-2285. doi: 10.1002/acn3.70135. Epub 2025 Aug 8. |
| 40629721 | Derived | Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8. |
| 40258203 | Derived | Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21. |
| 39626127 | Derived | Hartung HP, Benedict RHB, Berger T, Bermel RA, Brochet B, Carroll WM, Freedman MS, Holmoy T, Karabudak R, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Wuerfel J, Clinch S, Kadner K, Kuenzel T, Kulyk I, Raposo C, Thanei GA, Killestein J. Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm, Open-Label Trial. Neurology. 2024 Dec 24;103(12):e210049. doi: 10.1212/WNL.0000000000210049. Epub 2024 Dec 3. |
| 38649522 | Derived | Hartung HP, Berger T, Bermel RA, Brochet B, Carroll WM, Holmoy T, Karabudak R, Killestein J, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Buffels R, Garas M, Kadner K, Manfrini M, Wang Q, Freedman MS. ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial. J Neurol. 2024 Jul;271(7):4348-4360. doi: 10.1007/s00415-024-12326-z. Epub 2024 Apr 22. |
| 32503093 | Derived | Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep. |
Ocrelizumab was administered as 600 mg IV infused over approximately 3.5 hours every 24 weeks throughout the treatment period. |
| FG002 | Substudy - Shorter Infusion | Ocrelizumab was administered as 600 mg IV infused over approximately 2 hours and saline for remaining 1.5 hours, every 24 weeks throughout the treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Substudy (Week 24 to Week 144) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab | Ocrelizumab was administered intravenously (IV) as two 300-milligram (mg) infusions on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS) | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits for a minimum of 24 weeks/48 weeks. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to 4 years |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS | CDI is defined as an improvement of ≥1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Weeks 24 and 48 during Year 1 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed for CDP at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Year 1 (Weeks 24 and 48) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS | CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Weeks 48, 72 and 96 during Year 2 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 2, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed for CDP at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Particiopants | Year 2 (Weeks 72 and 96) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With 24-Week and 48-Week CDI at Year 4, as Measured Using EDSS | CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed for CDP at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Weeks 144, 168 and 192 during Year 4 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 4, as Measured Using EDSS | The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed for CDP at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Year 4 (Weeks 168 and 192) |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | Percentage of Participants | Year 1 (Week 48) |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | Percentage of Participants | Year 2 (Week 96) |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 3, As Measured Using EDSS | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | Percentage of Participants | Year 3 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 4, As Measured Using EDSS | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | Percentage of Participants | Year 4 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 24 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Change in Total EDSS Score | From Baseline to Week 24 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 48 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Change in Total EDSS Score | From Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 72 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Change in Total EDSS Score | From Baseline to Week 72 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 96 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Error | Change in Total EDSS Score | Baseline, Week 96 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 120 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Change in Total EDSS Score | Baseline, Week 120 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 144 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Error | Change in Total EDSS Score | Baseline, Week 144 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 168 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Error | Change in Total EDSS Score | Baseline, Week 168 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in EDSS Score at Week 192 | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Change in Total EDSS Score | Baseline, Week 192 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Without Protocol-Defined Event of Disease Activity | Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to 4 years |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Without Relapse | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to 4 years |
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| Primary | Annualized Relapse Rate | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. The adjusted annualized relapse rate is reported which is: Adjusted by age at disease diagnosis, Baseline EDSS, Presence of T1 Gd-enhanced lesion at screening and Presence of relapses in the last year prior to enrollment. Log-transformed exposure time is included as an offset variable. The report contains data up to week 192 of the treatment period of each individual participant. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. | Posted | Number | 95% Confidence Interval | events per participant per year | Baseline up to 4 years |
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| Primary | Sub Study: Number of Participants With IRRs Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy | ITT Population included all randomized participants in shorter infusion sub study. | Posted | Count of Participants | Participants | Week 24 through Week 144 |
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| Secondary | Percentage of Participants Who Are Relapse Free | Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 192 |
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| Secondary | Percentage of Participants With No Evidence of Protocol Defined Disease Activity | Protocol-defined disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8. (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan. Event-free rate | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Weeks 96, 144, 192 |
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| Secondary | Percentage of Participants Without Protocol-defined Event of Evidence of Progression (NEP) | NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20 percent [%] increase from baseline in timed 25 Foot Walk Test [T25FWT]; 20% increase from baseline in timed 9 hole peg test [9HPT]). CDP will be assessed using EDSS. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Weeks 96, 192 |
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| Secondary | Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD) | NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion. CDP will be assessed using EDSS. Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Weeks 96, 192 |
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| Secondary | Secondary: Change From Baseline in Multiple Sclerosis Functional Composite Score (MSFC) Total | MSFC combines the following: Timed 25 Foot Walk Test [T25FWT] for leg function &ambulation measured in seconds (sec). The longer it takes to walk, higher the score indicating deterioration; 9 Hole Peg Test [9HPT] for arm & handf unction measured in sec. Higher score=more time taken to complete test indicating deterioration. Paced Auditory Serial Addition Test [PASAT] for cognitive function (score range: 0-60, higher score=better cognitive processing speed). MSFC composite={[Average(1/9-HPT)-Baseline Mean(1/9-HPT)/Baseline Std Dev(1/9-HPT)]+[-(Average T25FWT-Baseline Mean T25FWT)/Baseline Std-Dev T25FWT]+[(PASAT-3-BaselineMean PASAT-3)/Baseline Std Dev PASAT-3]}/ 3.0. MSFC is based on the concept that scores for these 3 dimensions are combined to create a single score to detect change over time in a group of MS patients. Higher composite score=better overall function. Lower score=worse overall function. Higher mean change in total MSFC score=functional improvement at cohort level. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at the specified timepoint. Different participants may have contributed data for each timepoint. As raw composite scores have been reported here, it is not possible to provide a score range for this scale. | Posted | Mean | Standard Deviation | score on a scale | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
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| Secondary | Change From Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score. | The change in the mean score of T25FW is reported below. The time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. Higher times indicate worse performance and greater impairment. Subsequently, the lower the mean change in the score over time, the better performance. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | seconds | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
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| Secondary | Change From Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score | The mean change in 9 Hole Peg Test (9HPT)-score is reported. Participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. Both the dominant and non-dominant hands are tested twice (two consecutive trials for each hand). The participants are required to complete two successful trials for each hand. The amount of time (in seconds) required to place and remove all nine pegs is recorded for each trial. The number of seconds it takes to complete the test, the higher raw scores, which indicates deterioration. The lower mean change in the score over time, the better the performance. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | seconds | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
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| Secondary | Change From Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score | Mean change in the Paced Auditory Serial Addition Test [PASAT] score is reported. PASAT measures cognitive function. A total of 60 single digit numbers are presented by an audiotape/CD-rom at a constant rate in every 3 seconds (PASAT-3). Participants are required to add each new number to the one immediately before it. Due to the relative complexity of this test, a practice trial with a set of 10 numbers should be performed before the original test. Participants are allowed up to 3 practice trials. Two sets of numbers (forms A & B) are developed to be used alternatively in every visit to minimize memorizing. The number of correct answers is recorded. The PASAT score ranges from 0 to 60, with higher values representing a better outcome in cognitive processing speed. Subsequently, higher values in mean changes from baseline over the study time indicate improvement in cognitive function. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Weeks 24, 48, 72, 96, 120, 144, 168, 192 |
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| Secondary | Change From Baseline in Cognitive Performance as Measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) - Symbol Digits Modalities Test (SDMT) | BICAMS is assessing cognitive processing speed and verbal and visual memory. SDMT assesses processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 second time span. The higher the results, the better processing speed/working memory. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | responses over 90 seconds | Baseline, Weeks 48, 96, 144, 192 |
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| Secondary | Change From Baseline in Cognitive Performance as Measured by BICAMS -California Verbal Learning Test-II (CVLT-II) | BICAMS assesses cognitive processing speed and verbal and visual memory. The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. The maximum possible score is 80 and a minimum is 0. A higher score indicated better recall. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 48, 96, 144, 192 |
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| Secondary | Change From Baseline in Cognitive Performance as Measured by BICAMS - Brief Visuospatial Memory Test-Revised (BVMT-R) | BICAMS assesses cognitive processing speed and verbal and visual memory. BVMT-R assesses visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory. | Treatment efficacy was measured for this First Enrollment Cohort ITT population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | points on a scale | Baseline, Weeks 48, 96, 144, 192 |
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| Secondary | Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI | Number of Lesions are categorized as followed: 1, 2, 3, >1, >3 | ITT population | Posted | Number | Number of Lesions | Weeks 24, 48, 96, 144, 192 |
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| Secondary | Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI | Number of Lesions are categorized as followed: 1, 2, 3, >1 | ITT Population | Posted | Number | Number of Lesions | Baseline, Weeks 24, 48, 96, 144, 192 |
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| Secondary | Change From Baseline in Total T1 Hypointense Lesion Volume as Detected by Brain MRI | ITT Population | Posted | Mean | Standard Deviation | Micro Liter | Baseline, Weeks 48, 96, 144, 192 |
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| Secondary | Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI | Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI was measured for its volumes. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. | Posted | Number | Number of Lesions | Baseline, Weeks 8, 24, 48, 96, 144, 192 |
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| Secondary | Change From Baseline in Brain Volume as Detected by Brain MRI | Percentage change from Normalized brain volume in cm3 (cubic centimeter)values are reported | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. | Posted | Mean | Standard Deviation | Percentage Change in Volume (cm3) | From Baseline to Weeks 24, 48, 96, 144, 192 |
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| Secondary | Percentage of Participants Without Treatment Discontinuation | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. | Posted | Number | 95% Confidence Interval | Percentage % | Baseline up to 4 years |
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| Secondary | Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score | WPAI scale measures impact of health problems on work productivity and regular activities: Absenteeism (Work Time Missed) measuring % of work time missed due to health issues; Presenteeism:Calculated as the percentage of impairment while working due to health problems. Overall Work Impairment:Calculated by combining absenteeism and presenteeism using the formula:Overall Work Impairment=Absenteeism+(1-Absenteeism)×Presenteeism Overall Work Impairment=Absenteeism+(1-Absenteeism)×Presenteeism This formula accounts for both the time missed and the reduced productivity while at work. Activity Impairment: Calculated as the percentage of impairment in regular activities outside of work. Range: Each component is scored as 0%-100%). Higher % indicate greater impairment and worse outcomes. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | WAPI Sub-Score | Baseline, Weeks 24, 48, 96, 120, 144, 192 |
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| Secondary | SymptoMScreen Composite Score | The SMSS consists of 12 items which are assessed on a seven-point Likert scale that ranges from 0 (not at all affected) to 6 (total limitation) [7]. The total score ranges from 0 to 72, with higher scores indicating more severe symptom endorsement. | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | Change in SymptoMScreen Composite Score | Baseline, Weeks 24, 48, 96, 144, 192 |
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| Secondary | Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score | The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a questionnaire to examine the impact of multiple sclerosis (MS) on physical and psychological functioning from a patient's perspective, which includes 29 items self-reported measures associated with a physical scale and 9 items with a psychological scale. MSIS-29 scales are generated by summing items and it's ranging from 29-145'. The higher total MSIS-29 scores indicate a greater degree of disability. The mean change in MSIS-29 scores from baseline is reported. The decreasing values in the mean change from baseline indicate functional improvement from patients' perspective | First Enrollment Cohort ITT population. Treatment efficacy was measured for this First Enrollment Cohort. Number analyzed per timepoint are unique number of participants out of all the participants who were assessed at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Mean | Standard Deviation | Change in MSIS-29 Mean Score | Baseline, Weeks 24, 48, 96, 144, 192 |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety and ITT populations | Posted | Number | Percentage of Participants | Baseline up to 4 years |
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| Secondary | Substudy: Number of Participants With IRR Overall and by Dose at Randomization | ITT Population included all randomized participants in shorter infusion sub study. Number analyzed is the number of participants who received an infusion. | Posted | Count of Participants | Participants | From Week 24 to Week 144 |
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| Secondary | Substudy: Severity of IRRs | The number of participants with IRRs by most extreme intensity were reported (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 =life-threatening, grade 5 = fatal). Multiple IRRs in one participant are counted only once at the most extreme (highest) intensity observed. | ITT Population included all randomized participants in shorter infusion sub study. Number analyzed is the number of participants with IRR. | Posted | Count of Participants | Participants | From Week 24 to Week 144 |
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| Secondary | Substudy: Number of IRR Symptoms | ITT Population included all randomized participants in shorter infusion sub study. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with an infusion. | Posted | Number | symptoms | From Week 24 to Week 144 |
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| Secondary | Substudy: IRRs Leading to Treatment Discontinuation | ITT Population included all randomized participants in shorter infusion sub study. | Posted | Number | symptoms | From Week 24 to Week 144 |
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Main study: Up to 4 Years Sub-study: Week 24 to Week 144
Safety population included all enrolled participants who received any dose or part of a dose of ocrelizumab. Three participants from the 'Substudy - Conventional Infusion' arm received shorter infusions of ocrelizumab. Hence, these participants are represented in the 'Substudy - Shorter Infusion' arm for safety assessment.
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 | Ocrelizumab | Ocrelizumab was administered IV as two 300-mg infusions on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period. | 13 | 1,225 | 184 | 1,225 | 1,110 | 1,225 |
| EG001 | Substudy - Conventional Infusion | Ocrelizumab was administered as 600 mg IV infused over approximately 3.5 hours every 24 weeks throughout the treatment period. | 2 | 370 | 21 | 370 | 251 | 370 |
| EG002 | Substudy - Shorter Infusion | Ocrelizumab was administered as 600 mg IV infused over approximately 2 hours and saline for remaining 1.5 hours, every 24 weeks throughout the treatment period. | 1 | 375 | 19 | 375 | 276 | 375 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| PERICARDITIS | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| CRI DU CHAT SYNDROME | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
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| THYROID CYST | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
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| VISUAL IMPAIRMENT | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| ANAL FISTULA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| OESOPHAGEAL SPASM | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 25.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
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| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| EPIDIDYMITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| FALLOPIAN TUBE ABSCESS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| GENITAL HERPES | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| HEPATITIS A | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| MENINGITIS BACTERIAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| MENINGITIS VIRAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| ORCHITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PENILE ABSCESS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA MYCOPLASMAL | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| RENAL ABSCESS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SUBACUTE ENDOCARDITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| TYPHOID FEVER | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| VAGINAL INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| VARICELLA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| FRACTURE DISPLACEMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| CAPILLARY PERMEABILITY INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| TRANSAMINASES INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| BENIGN BREAST NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| INTRADUCTAL PAPILLOMA OF BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| CERVICOBRACHIAL SYNDROME | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSTONIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| RADICULOPATHY | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| TOXIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABORTION | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| HAEMORRHAGE IN PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DEPRESSIVE SYMPTOM | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| POST-TRAUMATIC STRESS DISORDER | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SOMATIC SYMPTOM DISORDER | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| VULVOVAGINAL PAIN | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NASAL TURBINATE HYPERTROPHY | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2019 | Apr 26, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
Not provided
Not provided
Not provided
| Substudy Stopped by Sponsor |
|
| Reason Not Specified |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 24 Number of Lesions 0 |
|
| ||||
| Week 24 Number of Lesions 1 |
|
| ||||
| Week 24 Number of Lesions 2 |
|
| ||||
| Week 24 Number of Lesions >1 |
|
| ||||
| Week 48 Number of Lesions 0 |
|
| ||||
| Week 48 Number of Lesions 1 |
|
| ||||
| Week 96 Number of Lesions 0 |
|
| ||||
| Week 96 Number of Lesions 1 |
|
| ||||
| Week 144 Number of Lesions 0 |
|
| ||||
| Week 144 Number of Lesions 1 |
|
| ||||
| Week 144 Number of Lesions 3 |
|
| ||||
| Week 144 Number of Lesions >1 |
|
| ||||
| Week 192 Number of Lesions 0 |
|
| ||||
| Week 192 Number of Lesions 1 |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 48 |
|
| ||||
| Week 96 |
|
| ||||
| Week 144 |
|
| ||||
| Week 192 |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 24 |
|
| ||||
| Week 48 |
|
| ||||
| Week 72 |
|
| ||||
| Week 96 |
|
| ||||
| Week 120 |
|
| ||||
| Week 144 |
|
| ||||
| Week 168 |
|
| ||||
| Week 192 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Adverse Events |
| |||||
| Serious Adverse Events |
|
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|
|
|