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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02861014




Registration number
NCT02861014
Ethics application status
Date submitted
5/08/2016
Date registered
10/08/2016
Date last updated
9/06/2021

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)
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
Secondary ID [1] 0 0
2015-005597-38
Secondary ID [2] 0 0
MA30005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period - 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
Timepoint [1] 0 0
Week 96
Secondary outcome [1] 0 0
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period - 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
Timepoint [1] 0 0
Baseline up to 24 weeks
Secondary outcome [2] 0 0
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period - 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
Timepoint [2] 0 0
Baseline up to 48 weeks
Secondary outcome [3] 0 0
Time to First Protocol-Defined Event of Disease Activity - 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.
Timepoint [3] 0 0
Baseline up to 96 Weeks
Secondary outcome [4] 0 0
Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) - The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Timepoint [4] 0 0
Baseline, Weeks: 24, 48, 72, 96
Secondary outcome [5] 0 0
Absolute Change From Baseline in EDSS Category at Week 96 - The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Timepoint [5] 0 0
Up to Week 96
Secondary outcome [6] 0 0
Percentage of Participants With a Baseline EDSS Score =2 With CDI at Week 96 - The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Timepoint [6] 0 0
Week 96
Secondary outcome [7] 0 0
Annualized Protocol-defined Relapse Rate at Week 96
Timepoint [7] 0 0
Week 96
Secondary outcome [8] 0 0
Time to Onset of 24-week Confirmed Disability Progression
Timepoint [8] 0 0
Baseline up to 96 Weeks
Secondary outcome [9] 0 0
Time to Onset of First Protocol-Defined Relapse - 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
Timepoint [9] 0 0
Baseline up to 96 Weeks
Secondary outcome [10] 0 0
Time to Onset of First New and/or Enlarging T2 Lesion
Timepoint [10] 0 0
Baseline up to 96 Weeks
Secondary outcome [11] 0 0
Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96 - 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
Timepoint [11] 0 0
Weeks: 24, 48, 96
Secondary outcome [12] 0 0
Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
Timepoint [12] 0 0
Baseline, Week 96
Secondary outcome [13] 0 0
Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
Timepoint [13] 0 0
Baseline, Week 96
Secondary outcome [14] 0 0
Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96 - 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.
Timepoint [14] 0 0
Weeks 24, 48, 96
Secondary outcome [15] 0 0
Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan - 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
Timepoint [15] 0 0
Weeks 24, 48, 96
Secondary outcome [16] 0 0
Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Timepoint [16] 0 0
Weeks 48, 96
Secondary outcome [17] 0 0
Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Timepoint [17] 0 0
Weeks 48, 96
Secondary outcome [18] 0 0
Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Timepoint [18] 0 0
Weeks 48, 96
Secondary outcome [19] 0 0
Adjusted Mean Percentage Change From Baseline in Brain Volume
Timepoint [19] 0 0
Weeks 24, 48, 96
Secondary outcome [20] 0 0
Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
Timepoint [20] 0 0
Weeks 48, 96
Secondary outcome [21] 0 0
Adjusted Mean Percentage Change From Baseline in White Matter Volume
Timepoint [21] 0 0
Weeks 48, 96
Secondary outcome [22] 0 0
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 - 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.
Timepoint [22] 0 0
Baseline, Weeks: 48, 96
Secondary outcome [23] 0 0
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 - 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.
Timepoint [23] 0 0
Baseline, Weeks 48, 96
Secondary outcome [24] 0 0
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 - 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.
Timepoint [24] 0 0
Baseline, Weeks 48, 96
Secondary outcome [25] 0 0
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 - 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.
Timepoint [25] 0 0
Baseline, Weeks: 48, 96
Secondary outcome [26] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [26] 0 0
Baseline up to to 96 weeks after the end of the Treatment Period

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah, New South Wales
Recruitment postcode(s) [1] 0 0
2217 - Kogarah, New South Wales
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
La Louvière
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Melsbroek
Country [7] 0 0
Belgium
State/province [7] 0 0
Overpelt
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Czechia
State/province [9] 0 0
Jihlava
Country [10] 0 0
Czechia
State/province [10] 0 0
Prague
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus N
Country [13] 0 0
Denmark
State/province [13] 0 0
Glostrup
Country [14] 0 0
Denmark
State/province [14] 0 0
Odense C
Country [15] 0 0
Denmark
State/province [15] 0 0
Sønderborg
Country [16] 0 0
Estonia
State/province [16] 0 0
Tallinn
Country [17] 0 0
Estonia
State/province [17] 0 0
Tartu
Country [18] 0 0
Finland
State/province [18] 0 0
Tampere
Country [19] 0 0
Finland
State/province [19] 0 0
Turku
Country [20] 0 0
France
State/province [20] 0 0
Besançon
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Bron
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Lille
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France
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Marseille
Country [26] 0 0
France
State/province [26] 0 0
Montpellier
Country [27] 0 0
France
State/province [27] 0 0
Nantes
Country [28] 0 0
France
State/province [28] 0 0
Nice
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France
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Paris
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France
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Reims
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Strasbourg
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France
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Toulouse
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France
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Tours
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Germany
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Augsburg
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Germany
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Berg
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Germany
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Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Bochum
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Germany
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Bonn
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Germany
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Buchholz
Country [40] 0 0
Germany
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Böblingen
Country [41] 0 0
Germany
State/province [41] 0 0
Dresden
Country [42] 0 0
Germany
State/province [42] 0 0
Düsseldorf
Country [43] 0 0
Germany
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Erbach/Odenwald
Country [44] 0 0
Germany
State/province [44] 0 0
Frankfurt
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
Country [46] 0 0
Germany
State/province [46] 0 0
Hamburg
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Hennigsdorf
Country [50] 0 0
Germany
State/province [50] 0 0
Itzehoe
Country [51] 0 0
Germany
State/province [51] 0 0
Kassel
Country [52] 0 0
Germany
State/province [52] 0 0
Leipzig
Country [53] 0 0
Germany
State/province [53] 0 0
Magdeburg
Country [54] 0 0
Germany
State/province [54] 0 0
Mainz
Country [55] 0 0
Germany
State/province [55] 0 0
Marburg
Country [56] 0 0
Germany
State/province [56] 0 0
München
Country [57] 0 0
Germany
State/province [57] 0 0
Münster
Country [58] 0 0
Germany
State/province [58] 0 0
Neuruppin
Country [59] 0 0
Germany
State/province [59] 0 0
Oldenburg in Holstein
Country [60] 0 0
Germany
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Potsdam
Country [61] 0 0
Germany
State/province [61] 0 0
Stuttgart
Country [62] 0 0
Germany
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Tübingen
Country [63] 0 0
Germany
State/province [63] 0 0
Ulm
Country [64] 0 0
Germany
State/province [64] 0 0
Westerstede
Country [65] 0 0
Ireland
State/province [65] 0 0
Cork
Country [66] 0 0
Ireland
State/province [66] 0 0
Dublin 4
Country [67] 0 0
Ireland
State/province [67] 0 0
Dublin
Country [68] 0 0
Italy
State/province [68] 0 0
Abruzzo
Country [69] 0 0
Italy
State/province [69] 0 0
Campania
Country [70] 0 0
Italy
State/province [70] 0 0
Emilia-Romagna
Country [71] 0 0
Italy
State/province [71] 0 0
Lazio
Country [72] 0 0
Italy
State/province [72] 0 0
Liguria
Country [73] 0 0
Italy
State/province [73] 0 0
Lombardia
Country [74] 0 0
Italy
State/province [74] 0 0
Marche
Country [75] 0 0
Italy
State/province [75] 0 0
Molise
Country [76] 0 0
Italy
State/province [76] 0 0
Puglia
Country [77] 0 0
Italy
State/province [77] 0 0
Sardegna
Country [78] 0 0
Italy
State/province [78] 0 0
Sicilia
Country [79] 0 0
Italy
State/province [79] 0 0
Toscana
Country [80] 0 0
Italy
State/province [80] 0 0
Umbria
Country [81] 0 0
Italy
State/province [81] 0 0
Veneto
Country [82] 0 0
Netherlands
State/province [82] 0 0
Breda
Country [83] 0 0
Netherlands
State/province [83] 0 0
Nieuwegein
Country [84] 0 0
Netherlands
State/province [84] 0 0
Rotterdam
Country [85] 0 0
Netherlands
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Sittard-Geleen
Country [86] 0 0
Netherlands
State/province [86] 0 0
Tilburg
Country [87] 0 0
Norway
State/province [87] 0 0
Bergen
Country [88] 0 0
Norway
State/province [88] 0 0
Drammen
Country [89] 0 0
Spain
State/province [89] 0 0
Asturias
Country [90] 0 0
Spain
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Barcelona
Country [91] 0 0
Spain
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Castellon
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Spain
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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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Spain
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Pontevedra
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Spain
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Cadiz
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Valencia
Country [101] 0 0
Sweden
State/province [101] 0 0
Göteborg
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Sweden
State/province [102] 0 0
Jönköping
Country [103] 0 0
Sweden
State/province [103] 0 0
Stockholm
Country [104] 0 0
Switzerland
State/province [104] 0 0
Basel
Country [105] 0 0
Switzerland
State/province [105] 0 0
Lausanne
Country [106] 0 0
Turkey
State/province [106] 0 0
Ankara
Country [107] 0 0
Turkey
State/province [107] 0 0
Istanbul
Country [108] 0 0
Turkey
State/province [108] 0 0
Izmir
Country [109] 0 0
Turkey
State/province [109] 0 0
Kocaeli
Country [110] 0 0
Turkey
State/province [110] 0 0
Mersin
Country [111] 0 0
Turkey
State/province [111] 0 0
Samsun
Country [112] 0 0
Turkey
State/province [112] 0 0
Trabzon
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Birmingham
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Edinburgh
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Exeter
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Glasgow
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Inverness
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Leeds
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Newcastle upon Tyne
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Salford
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Sheffield
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Swansea
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02861014
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications