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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03085810
Ethics application status
Date submitted
16/03/2017
Date registered
21/03/2017

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
Timepoint [20] 0 0
Baseline up to 4 years
Primary outcome [21] 0 0
Time to First Relapse
Timepoint [21] 0 0
Baseline up to 4 years
Primary outcome [22] 0 0
Annualized Relapse Rate
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
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
Timepoint [2] 0 0
Weeks 96, 144, 192
Secondary outcome [3] 0 0
Percentage of Participants With no Evidence of Progression (NEP)
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)
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)
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
Sex
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
NA
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
24/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/04/2023
Sample size
Target
Accrual to date
Final
1239
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
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Country [143] 0 0
Turkey
State/province [143] 0 0
Istanbul
Country [144] 0 0
Turkey
State/province [144] 0 0
Samsun
Country [145] 0 0
Turkey
State/province [145] 0 0
Trabzon
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Cambridge
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Glasgow
Country [148] 0 0
United Kingdom
State/province [148] 0 0
London
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Newcastle upon Tyne
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Plymouth
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Salford
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Swansea

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03085810