Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01247324




Registration number
NCT01247324
Ethics application status
Date submitted
23/11/2010
Date registered
24/11/2010
Date last updated
4/03/2024

Titles & IDs
Public title
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Scientific title
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
Secondary ID [1] 0 0
2010-020337-99
Secondary ID [2] 0 0
WA21092
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Interferon beta-1a 44 mcg SC - Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

Experimental: Ocrelizumab - Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
Timepoint [1] 0 0
Week 96
Secondary outcome [1] 0 0
Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
Timepoint [1] 0 0
Week 108
Secondary outcome [2] 0 0
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
Timepoint [2] 0 0
Baseline up to Week 96
Secondary outcome [3] 0 0
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
Timepoint [3] 0 0
Baseline up to Week 96
Secondary outcome [4] 0 0
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
Timepoint [4] 0 0
Week 96
Secondary outcome [5] 0 0
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period
Timepoint [5] 0 0
Week 108
Secondary outcome [6] 0 0
Number of T1 Hypointense Lesions During the Double-Blind Treatment
Timepoint [6] 0 0
Baseline up to Week 96
Secondary outcome [7] 0 0
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96
Timepoint [7] 0 0
Baseline, Week 96
Secondary outcome [8] 0 0
Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96
Timepoint [8] 0 0
From Week 24 up to Week 96
Secondary outcome [9] 0 0
Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96
Timepoint [9] 0 0
Baseline, Week 96
Secondary outcome [10] 0 0
Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96
Timepoint [10] 0 0
Week 96
Secondary outcome [11] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
Baseline up to 588 weeks
Secondary outcome [12] 0 0
Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)
Timepoint [12] 0 0
Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96
Secondary outcome [13] 0 0
Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
Timepoint [13] 0 0
Baseline up to week 96

Eligibility
Key inclusion criteria
* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
* Neurologic stability for greater than or equal to (>=) 30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary progressive multiple sclerosis
* Disease duration of more than 10 years in participants with EDSS less than or equal to (<=) 2.0 at screening
* Contraindications for MRI
* Known presence of other neurological disorders which may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection (e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or iv corticosteroids
* Contraindications to Rebif or incompatibility with Rebif use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
31/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
821
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital; Department of Neurology - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad Autonoma Bs As
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Belgium
State/province [25] 0 0
Brugge
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles
Country [27] 0 0
Belgium
State/province [27] 0 0
Roeselare
Country [28] 0 0
Brazil
State/province [28] 0 0
GO
Country [29] 0 0
Brazil
State/province [29] 0 0
RS
Country [30] 0 0
Brazil
State/province [30] 0 0
SC
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Pleven
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Chile
State/province [33] 0 0
Valparaiso
Country [34] 0 0
Czechia
State/province [34] 0 0
Brno
Country [35] 0 0
Czechia
State/province [35] 0 0
Hradec Kralove
Country [36] 0 0
Czechia
State/province [36] 0 0
Jihlava
Country [37] 0 0
Czechia
State/province [37] 0 0
Pardubice
Country [38] 0 0
Czechia
State/province [38] 0 0
Prague
Country [39] 0 0
Czechia
State/province [39] 0 0
Teplice
Country [40] 0 0
Estonia
State/province [40] 0 0
Tallinn
Country [41] 0 0
Estonia
State/province [41] 0 0
Tartu
Country [42] 0 0
Finland
State/province [42] 0 0
Tampere
Country [43] 0 0
France
State/province [43] 0 0
Bordeaux
Country [44] 0 0
France
State/province [44] 0 0
Clermont Ferrand
Country [45] 0 0
France
State/province [45] 0 0
Nancy
Country [46] 0 0
France
State/province [46] 0 0
Nimes
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Dresden
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Mainz
Country [53] 0 0
Germany
State/province [53] 0 0
Oldenburg
Country [54] 0 0
Germany
State/province [54] 0 0
Prien
Country [55] 0 0
Germany
State/province [55] 0 0
Rostock
Country [56] 0 0
Germany
State/province [56] 0 0
Tübingen
Country [57] 0 0
Germany
State/province [57] 0 0
Westerstede
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Tatabánya
Country [60] 0 0
Israel
State/province [60] 0 0
Ramat-Gan
Country [61] 0 0
Italy
State/province [61] 0 0
Lazio
Country [62] 0 0
Italy
State/province [62] 0 0
Lombardia
Country [63] 0 0
Italy
State/province [63] 0 0
Valle D?Aosta
Country [64] 0 0
Italy
State/province [64] 0 0
Veneto
Country [65] 0 0
Latvia
State/province [65] 0 0
Riga
Country [66] 0 0
Lithuania
State/province [66] 0 0
Kaunas
Country [67] 0 0
Lithuania
State/province [67] 0 0
Klaipeda
Country [68] 0 0
Lithuania
State/province [68] 0 0
Vilnius
Country [69] 0 0
Mexico
State/province [69] 0 0
Mexico CITY (federal District)
Country [70] 0 0
Mexico
State/province [70] 0 0
Nuevo LEON
Country [71] 0 0
Netherlands
State/province [71] 0 0
Nieuwegein
Country [72] 0 0
Peru
State/province [72] 0 0
Callao
Country [73] 0 0
Peru
State/province [73] 0 0
Lima
Country [74] 0 0
Peru
State/province [74] 0 0
Pueblo Libre
Country [75] 0 0
Poland
State/province [75] 0 0
Gdansk
Country [76] 0 0
Poland
State/province [76] 0 0
Katowice
Country [77] 0 0
Poland
State/province [77] 0 0
Plewiska
Country [78] 0 0
Portugal
State/province [78] 0 0
Braga
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moskovskaja Oblast
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Sankt Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Sverdlovsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Tjumen
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Kemerovo
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Novosibirsk
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Samara
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Smolensk
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Tyumen
Country [88] 0 0
Serbia
State/province [88] 0 0
Belgrade
Country [89] 0 0
Serbia
State/province [89] 0 0
Kragujevac
Country [90] 0 0
Serbia
State/province [90] 0 0
NIS
Country [91] 0 0
Slovakia
State/province [91] 0 0
Bratislava
Country [92] 0 0
Slovakia
State/province [92] 0 0
Zilina
Country [93] 0 0
South Africa
State/province [93] 0 0
Durban
Country [94] 0 0
Spain
State/province [94] 0 0
Tenerife
Country [95] 0 0
Spain
State/province [95] 0 0
Vizcaya
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Sevilla
Country [98] 0 0
Switzerland
State/province [98] 0 0
Basel
Country [99] 0 0
Switzerland
State/province [99] 0 0
Lugano
Country [100] 0 0
Tunisia
State/province [100] 0 0
Mannouba
Country [101] 0 0
Tunisia
State/province [101] 0 0
Monastir
Country [102] 0 0
Tunisia
State/province [102] 0 0
Tunis
Country [103] 0 0
Ukraine
State/province [103] 0 0
Donetsk
Country [104] 0 0
Ukraine
State/province [104] 0 0
Kharkov
Country [105] 0 0
Ukraine
State/province [105] 0 0
Kyiv
Country [106] 0 0
Ukraine
State/province [106] 0 0
Lviv
Country [107] 0 0
Ukraine
State/province [107] 0 0
Vinnytsya
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Liverpool
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01247324