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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02861014
Registration number
NCT02861014
Ethics application status
Date submitted
5/08/2016
Date registered
10/08/2016
Date last updated
27/01/2022
Titles & IDs
Public title
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
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Scientific title
An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
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Secondary ID [1]
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2015-005597-38
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Secondary ID [2]
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MA30005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ocrelizumab
Experimental: Ocrelizumab - Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Other interventions: Ocrelizumab
Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
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Assessment method [1]
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A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:
A protocol-defined relapse (PDR)
24-week CDP based on increase in EDSS while on treatment with ocrelizumab
A T1 Gd-enhanced lesion after Week 8
A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
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Timepoint [1]
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Week 96
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Secondary outcome [1]
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Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
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Assessment method [1]
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A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:
A protocol-defined relapse (PDR)
24-week CDP based on increase in EDSS while on treatment with ocrelizumab
A T1 Gd-enhanced lesion after Week 8
A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
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Timepoint [1]
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Baseline up to 24 weeks
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Secondary outcome [2]
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Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
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Assessment method [2]
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A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab:
A protocol-defined relapse (PDR)
24-week CDP based on increase in EDSS while on treatment with ocrelizumab
A T1 Gd-enhanced lesion after Week 8
A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
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Timepoint [2]
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Baseline up to 48 weeks
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Secondary outcome [3]
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Time to First Protocol-Defined Event of Disease Activity
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Assessment method [3]
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The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab:
A protocol-defined relapse defined as: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment
24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab
A T1 Gd-enhanced lesion after Week 8
A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan.
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Timepoint [3]
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Baseline up to 96 Weeks
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Secondary outcome [4]
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Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
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Assessment method [4]
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The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
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Timepoint [4]
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Baseline, Weeks: 24, 48, 72, 96
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Secondary outcome [5]
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Absolute Change From Baseline in EDSS Category at Week 96
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Assessment method [5]
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The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
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Timepoint [5]
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Up to Week 96
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Secondary outcome [6]
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Percentage of Participants With a Baseline EDSS Score =2 With CDI at Week 96
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Assessment method [6]
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The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
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Timepoint [6]
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Week 96
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Secondary outcome [7]
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Annualized Protocol-defined Relapse Rate at Week 96
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Assessment method [7]
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Timepoint [7]
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Week 96
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Secondary outcome [8]
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Time to Onset of 24-week Confirmed Disability Progression
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Assessment method [8]
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Timepoint [8]
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Baseline up to 96 Weeks
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Secondary outcome [9]
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Time to Onset of First Protocol-Defined Relapse
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Assessment method [9]
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A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria:
Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications)
Symptoms should be preceded by neurological stability for at least 30 days
Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least:
= 0.5 points on EDSS scale
or = 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
or = 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
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Timepoint [9]
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Baseline up to 96 Weeks
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Secondary outcome [10]
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Time to Onset of First New and/or Enlarging T2 Lesion
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Assessment method [10]
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Timepoint [10]
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Baseline up to 96 Weeks
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Secondary outcome [11]
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Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96
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Assessment method [11]
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Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans
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Timepoint [11]
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Weeks: 24, 48, 96
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Secondary outcome [12]
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Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
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Assessment method [12]
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Timepoint [12]
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Baseline, Week 96
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Secondary outcome [13]
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Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
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Assessment method [13]
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Timepoint [13]
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Baseline, Week 96
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Secondary outcome [14]
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Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96
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Assessment method [14]
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The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis.
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Timepoint [14]
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Weeks 24, 48, 96
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Secondary outcome [15]
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Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan
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Assessment method [15]
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Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans
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Timepoint [15]
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Weeks 24, 48, 96
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Secondary outcome [16]
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Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
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Assessment method [16]
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Timepoint [16]
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Weeks 48, 96
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Secondary outcome [17]
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Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
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Assessment method [17]
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Timepoint [17]
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Weeks 48, 96
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Secondary outcome [18]
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Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
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Assessment method [18]
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Timepoint [18]
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Weeks 48, 96
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Secondary outcome [19]
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Adjusted Mean Percentage Change From Baseline in Brain Volume
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Assessment method [19]
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Timepoint [19]
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Weeks 24, 48, 96
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Secondary outcome [20]
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Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
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Assessment method [20]
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Timepoint [20]
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Weeks 48, 96
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Secondary outcome [21]
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Adjusted Mean Percentage Change From Baseline in White Matter Volume
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Assessment method [21]
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Timepoint [21]
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Weeks 48, 96
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Secondary outcome [22]
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Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
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Assessment method [22]
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Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing 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 sec time span. The higher the results, the better processing speed/working memory.
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Timepoint [22]
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Baseline, Weeks: 48, 96
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Secondary outcome [23]
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Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
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Assessment method [23]
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Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing 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.
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Timepoint [23]
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Baseline, Weeks 48, 96
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Secondary outcome [24]
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Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
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Assessment method [24]
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0
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing 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 sec time span.
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Timepoint [24]
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Baseline, Weeks 48, 96
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Secondary outcome [25]
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Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
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Assessment method [25]
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0
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing 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.
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Timepoint [25]
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Baseline, Weeks: 48, 96
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Secondary outcome [26]
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [26]
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Timepoint [26]
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Baseline up to to 96 weeks after the end of the Treatment Period
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Eligibility
Key inclusion criteria
- Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first symptom, of less than (<) 10 years
- Have received no more than two prior DMTs, and the discontinuation of the most recent
DMT was due to lack of efficacy
- Suboptimal disease control while on a DMT
- Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- For women of childbearing potential: agreement to use an acceptable birth control
method during the treatment period and for at least 6 months after the last dose of
study drug
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or
progressive relapsing multiple sclerosis (MS)
- Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- Known presence of other neurological disorders
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study
- History or currently active primary or secondary immunodeficiency
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- History of opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
excluding fungal infection of nail beds
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/12/2020
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Sample size
Target
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Accrual to date
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Final
681
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St George Hospital - Kogarah, New South Wales
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Recruitment postcode(s) [1]
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2217 - Kogarah, New South Wales
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Recruitment outside Australia
Country [1]
0
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Belgium
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State/province [1]
0
0
Bruxelles
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Country [2]
0
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Belgium
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State/province [2]
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0
Edegem
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Country [3]
0
0
Belgium
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State/province [3]
0
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Gent
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Country [4]
0
0
Belgium
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State/province [4]
0
0
La Louvière
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Country [5]
0
0
Belgium
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State/province [5]
0
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Leuven
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Melsbroek
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Overpelt
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Country [8]
0
0
Czechia
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State/province [8]
0
0
Brno
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Country [9]
0
0
Czechia
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State/province [9]
0
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Jihlava
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Country [10]
0
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Czechia
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State/province [10]
0
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Prague
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Country [11]
0
0
Czechia
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State/province [11]
0
0
Praha
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Country [12]
0
0
Denmark
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State/province [12]
0
0
Aarhus N
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Country [13]
0
0
Denmark
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State/province [13]
0
0
Glostrup
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Country [14]
0
0
Denmark
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State/province [14]
0
0
Odense C
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Country [15]
0
0
Denmark
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State/province [15]
0
0
Sønderborg
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Country [16]
0
0
Estonia
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State/province [16]
0
0
Tallinn
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Country [17]
0
0
Estonia
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State/province [17]
0
0
Tartu
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Country [18]
0
0
Finland
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State/province [18]
0
0
Tampere
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Country [19]
0
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Finland
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State/province [19]
0
0
Turku
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Country [20]
0
0
France
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State/province [20]
0
0
Besançon
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Country [21]
0
0
France
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State/province [21]
0
0
Bordeaux
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Country [22]
0
0
France
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State/province [22]
0
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Bron
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Country [23]
0
0
France
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State/province [23]
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0
Clermont-Ferrand
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Country [24]
0
0
France
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State/province [24]
0
0
Lille
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Country [25]
0
0
France
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State/province [25]
0
0
Marseille
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Country [26]
0
0
France
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State/province [26]
0
0
Montpellier
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Country [27]
0
0
France
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State/province [27]
0
0
Nantes
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Country [28]
0
0
France
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State/province [28]
0
0
Nice
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Country [29]
0
0
France
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0
0
Paris
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Country [30]
0
0
France
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0
0
Reims
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0
0
France
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0
0
Strasbourg
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0
0
France
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State/province [32]
0
0
Toulouse
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Country [33]
0
0
France
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State/province [33]
0
0
Tours
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Country [34]
0
0
Germany
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0
0
Augsburg
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0
0
Germany
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0
Berg
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0
0
Germany
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0
Berlin
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0
0
Germany
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0
Bochum
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0
0
Germany
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Bonn
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0
0
Germany
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0
Buchholz
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0
Germany
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0
Böblingen
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0
0
Germany
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0
Dresden
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0
Germany
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0
Düsseldorf
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Germany
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Erbach/Odenwald
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Germany
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Frankfurt
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Germany
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Freiburg
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0
0
Germany
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0
Hamburg
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0
0
Germany
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0
Hannover
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Germany
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0
Heidelberg
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0
0
Germany
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State/province [49]
0
0
Hennigsdorf
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0
0
Germany
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0
0
Itzehoe
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0
0
Germany
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0
Kassel
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0
0
Germany
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0
Leipzig
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0
0
Germany
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0
Magdeburg
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0
0
Germany
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0
Mainz
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0
0
Germany
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0
0
Marburg
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0
0
Germany
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München
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Germany
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Münster
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0
0
Germany
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0
0
Neuruppin
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0
0
Germany
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0
0
Oldenburg in Holstein
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0
0
Germany
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0
0
Potsdam
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0
0
Germany
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0
0
Stuttgart
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0
0
Germany
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State/province [62]
0
0
Tübingen
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0
0
Germany
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State/province [63]
0
0
Ulm
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0
0
Germany
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State/province [64]
0
0
Westerstede
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Country [65]
0
0
Ireland
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State/province [65]
0
0
Cork
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Country [66]
0
0
Ireland
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State/province [66]
0
0
Dublin 4
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Country [67]
0
0
Ireland
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0
0
Dublin
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Country [68]
0
0
Italy
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0
0
Abruzzo
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Country [69]
0
0
Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Italy
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Marche
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Italy
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Molise
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Italy
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Veneto
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Netherlands
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Breda
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Nieuwegein
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Rotterdam
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Netherlands
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Tilburg
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Norway
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Bergen
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Norway
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Drammen
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Barcelona
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Castellon
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Girona
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Spain
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LA Coruña
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Spain
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Lerida
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Spain
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Madrid
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Pontevedra
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Cadiz
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Murcia
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Sevilla
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Valencia
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Göteborg
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Sweden
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Jönköping
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Lausanne
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Turkey
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Turkey
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Istanbul
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Turkey
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Turkey
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Mersin
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Turkey
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Samsun
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Turkey
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Trabzon
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United Kingdom
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Birmingham
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Edinburgh
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Exeter
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Glasgow
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Inverness
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Leeds
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London
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Newcastle upon Tyne
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Salford
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Sheffield
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Swansea
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to
assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting
Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a
Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4
weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),
and a Follow-up period of at least 2 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02861014
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02861014
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