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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03085810




Registration number
NCT03085810
Ethics application status
Date submitted
16/03/2017
Date registered
21/03/2017
Date last updated
9/06/2021

Titles & IDs
Public title
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Scientific title
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Secondary ID [1] 0 0
2016-002937-31
Secondary ID [2] 0 0
MA30143
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
Treatment: Drugs - Ocrelizumab

Experimental: Ocrelizumab - 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.

Active Comparator: Substudy Group 1 - 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

Experimental: Substudy Group 2 - 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


Treatment: Drugs: Ocrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 and 48 Weeks, As Measured Using Expanded Disability Status Scale (EDSS)
Timepoint [1] 0 0
Baseline up to 4 years
Primary outcome [2] 0 0
Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS
Timepoint [2] 0 0
Year 1
Primary outcome [3] 0 0
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS
Timepoint [3] 0 0
Year 1
Primary outcome [4] 0 0
Percentage of Participants With CDI at Year 2, As Measured Using EDSS
Timepoint [4] 0 0
Year 2
Primary outcome [5] 0 0
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS
Timepoint [5] 0 0
Year 2
Primary outcome [6] 0 0
Percentage of Participants With CDI at Year 4, As Measured Using EDSS
Timepoint [6] 0 0
Year 4
Primary outcome [7] 0 0
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS
Timepoint [7] 0 0
Year 4
Primary outcome [8] 0 0
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS
Timepoint [8] 0 0
Year 1
Primary outcome [9] 0 0
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS
Timepoint [9] 0 0
Year 2
Primary outcome [10] 0 0
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS
Timepoint [10] 0 0
Year 3
Primary outcome [11] 0 0
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS
Timepoint [11] 0 0
Year 4
Primary outcome [12] 0 0
Mean Change From Baseline in EDSS Score at Week 24
Timepoint [12] 0 0
Baseline, Week 24
Primary outcome [13] 0 0
Mean Change From Baseline in EDSS Score at Week 48
Timepoint [13] 0 0
Baseline, Week 48
Primary outcome [14] 0 0
Mean Change From Baseline in EDSS Score at Week 72
Timepoint [14] 0 0
Baseline, Week 72
Primary outcome [15] 0 0
Mean Change From Baseline in EDSS Score at Week 96
Timepoint [15] 0 0
Baseline, Week 96
Primary outcome [16] 0 0
Mean Change From Baseline in EDSS Score at Week 120
Timepoint [16] 0 0
Baseline, Week 120
Primary outcome [17] 0 0
Mean Change From Baseline in EDSS Score at Week 144
Timepoint [17] 0 0
Baseline, Week 144
Primary outcome [18] 0 0
Mean Change From Baseline in EDSS Score at Week 168
Timepoint [18] 0 0
Baseline, Week 168
Primary outcome [19] 0 0
Mean Change From Baseline in EDSS Score at Week 192
Timepoint [19] 0 0
Baseline, Week 192
Primary outcome [20] 0 0
Time to First 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.
Timepoint [20] 0 0
Baseline up to 4 years
Primary outcome [21] 0 0
Time to First Relapse - Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Timepoint [21] 0 0
Baseline up to 4 years
Primary outcome [22] 0 0
Annualized Relapse Rate - Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Timepoint [22] 0 0
Baseline up to 4 years
Primary outcome [23] 0 0
Proportion of Participants with Infusion Related Reactions (IRRs) Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy
Timepoint [23] 0 0
From Week 24 through Week 192
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Weeks 48, 96, 144, 192
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Weeks 96, 144, 192
Secondary outcome [3] 0 0
Percentage of Participants With no 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.
Timepoint [3] 0 0
Weeks 96, 192
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Weeks 96, 192
Secondary outcome [5] 0 0
Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score
Timepoint [5] 0 0
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Secondary outcome [6] 0 0
Change from Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score
Timepoint [6] 0 0
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Secondary outcome [7] 0 0
Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score
Timepoint [7] 0 0
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Secondary outcome [8] 0 0
Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score
Timepoint [8] 0 0
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Secondary outcome [9] 0 0
Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Timepoint [9] 0 0
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Secondary outcome [10] 0 0
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Timepoint [10] 0 0
Baseline, Weeks 8, 24, 48, 96, 144, 192
Secondary outcome [11] 0 0
Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI
Timepoint [11] 0 0
Baseline, Weeks 8, 24, 48, 96, 144, 192
Secondary outcome [12] 0 0
Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI
Timepoint [12] 0 0
Baseline, Weeks 8, 24, 48, 96, 144, 192
Secondary outcome [13] 0 0
Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI
Timepoint [13] 0 0
Baseline, Weeks 8, 24, 48, 96, 144, 192
Secondary outcome [14] 0 0
Change From Baseline in Brain Volume as Detected by Brain MRI
Timepoint [14] 0 0
Baseline, Weeks 8, 24, 48, 96, 144, 192
Secondary outcome [15] 0 0
Time to Treatment Discontinuation
Timepoint [15] 0 0
Baseline up to 4 years
Secondary outcome [16] 0 0
Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score
Timepoint [16] 0 0
Baseline, Weeks 24, 48, 96, 120, 144, 192
Secondary outcome [17] 0 0
SymptoMScreen Composite Score
Timepoint [17] 0 0
Baseline, Weeks 24, 48, 96, 120, 144, 192
Secondary outcome [18] 0 0
Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score
Timepoint [18] 0 0
Baseline, Weeks 24, 48, 96, 120, 144, 192
Secondary outcome [19] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Short term safety related to the infusion (infusion-related reactions [IRRs], during infusion and up to 24h after) the overall safety is measured continuously at clinical visits and including every 8 week telephone visits up to 48 weeks post study.
Timepoint [19] 0 0
Baseline up to 4 years
Secondary outcome [20] 0 0
Proportion of Participants with IRR (overall) in the Shorter Infusion Substudy
Timepoint [20] 0 0
From Week 24 through Week 192
Secondary outcome [21] 0 0
Proportion of Participants with IRR By Dose at Randomization in the Shorter Infusion Substudy
Timepoint [21] 0 0
From Week 24 through Week 192
Secondary outcome [22] 0 0
Proportion of Participants with IRRs Leading to Treatment Discontinuation in the Shorter Infusion Substudy
Timepoint [22] 0 0
From Week 24 through Week 192

Eligibility
Key inclusion criteria
- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria

- Have a length of disease duration, from first documented clinical attack consistent
with MS disease of less than or equal to (</=) 3 years

- Within the last 12 months one or more clinically reported relapse(s) or one or more
signs of MRI activity

- EDSS of 0.0 to 3.5 inclusive, at screening

- An agreement to use an acceptable birth control method for women of childbearing
potential, during the treatment period and for at least 6 months or longer 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 or history of primary progressive or
progressive relapsing MS

- Inability to complete an MRI

- Known presence of other neurological disorders

Exclusions Related to General Health:

- Pregnancy or lactation

- Participants intending to become pregnant during the study or within 6 months after
the last dose of the study drug

- 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

- Lack of peripheral venous access

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

- Significant or uncontrolled somatic disease or any other significant disease that may
preclude participant from participating in the study

- Congestive heart failure (New York Heart Association III or IV functional severity)

- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
(excluding fungal infection of nail beds) or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or
oral antibiotics 2 weeks prior to screening

- History of malignancy, major opportunistic infections, alcohol or drug abuse,
recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

- Received any prior approved disease modifying treatment (DMT) with a label for MS, for
example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab,
fingolimod, teiflunomide and dimethylfumarate

- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the
baseline visit

- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab,
atacicept, belimumab, or ofatumumab)

- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic
therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine,
methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone
marrow transplantation)

- Treatment with investigational DMT

- Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to
screening

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

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
Active, not recruiting
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,QLD,VIC,WA
Recruitment hospital [1] 0 0
Brain and Mind Centre - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 0 0
Royal North Shore Hospital; Department of Neurology - St Leonards
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Box Hill Hospital; Department of Neurology - Box Hill
Recruitment hospital [7] 0 0
Austin Hospital; Department of Neurology - Heidelberg
Recruitment hospital [8] 0 0
Royal Melbourne Hospital; Department of Neurology - Parkville
Recruitment hospital [9] 0 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
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United States of America
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Minnesota
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Tennessee
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Rosario
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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La Louvière
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Belgium
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Liège
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Overpelt
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MG
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RS
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Sofia
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Ontario
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Zagreb
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Glostrup
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Besançon
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Bron
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Caen
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Gonesse
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Rennes
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Rouen
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Toulouse
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Tours
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Barsinghausen
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Berlin
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Bochum
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Böblingen
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Germany
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Dresden
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Düsseldorf
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Erbach/Odenwald
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Kassel
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Germany
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Kiel
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Germany
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Marburg
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Germany
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München
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Germany
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Münster
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Germany
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Neuburg
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Germany
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Seesen
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Germany
State/province [84] 0 0
Tübingen
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Hungary
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Budapest
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Hungary
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Esztergom
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Hungary
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Szeged
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Italy
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Calabria
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Italy
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Campania
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Italy
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Friuli-Venezia Giulia
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Italy
State/province [91] 0 0
Lazio
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Italy
State/province [92] 0 0
Liguria
Country [93] 0 0
Italy
State/province [93] 0 0
Lombardia
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Italy
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Molise
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Italy
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Sicilia
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Italy
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Toscana
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Kuwait
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Kuwait
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Lebanon
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Beirut
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Mexico
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Sinaloa
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Mexico
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Tlaxcala
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Mexico
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Ciudad de México
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Netherlands
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'S Hertogenbosch
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Amsterdam
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Netherlands
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Gouda
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Netherlands
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Sittard-Geleen
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Norway
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Lørenskog
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Norway
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Stavanger
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Katowice
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Krakow
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Lodz
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Lublin
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Warszawa
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Portugal
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Almada
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Loures
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Portugal
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Porto
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Romania
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Bucharest
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Romania
State/province [121] 0 0
Sibiu
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03085810
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