Register a trial

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/NCT05269004




Registration number
NCT05269004
Ethics application status
Date submitted
11/02/2022
Date registered
7/03/2022

Titles & IDs
Public title
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Scientific title
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
Secondary ID [1] 0 0
2021-005746-15
Secondary ID [2] 0 0
MN43964
Universal Trial Number (UTN)
Trial acronym
OLERO
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ocrelizumab

Experimental: Ocrelizumab - Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.


Treatment: Drugs: Ocrelizumab
Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
Timepoint [1] 0 0
Up to 44 months
Secondary outcome [1] 0 0
Change in Expanded Disability Status Scale (EDSS) score over time
Timepoint [1] 0 0
Week 0, 24, 48, 72, 96, 120, 168
Secondary outcome [2] 0 0
Change in 9-Hole Peg Test (9HPT) over time
Timepoint [2] 0 0
Week 0, 24, 48, 72, 96, 120, 168
Secondary outcome [3] 0 0
Change in Timed 25-Foot Walk Test (T25FWT) over time
Timepoint [3] 0 0
Week 0, 24, 48, 72, 96, 120, 168
Secondary outcome [4] 0 0
The number of T1 lesions and number of new or enlarging T2 lesions
Timepoint [4] 0 0
Week 0, 24, 48, 72, 96, 120, 168
Secondary outcome [5] 0 0
The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
Timepoint [5] 0 0
Week 0, 24, 48, 72, 96, 120, 168

Eligibility
Key inclusion criteria
Inclusion criteria

* Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* Concurrent participation in any clinical trial (other than the Parent study)
* Unable or unwilling to comply with the requirements of the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
3/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Vermont
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma Bs As
Country [28] 0 0
Argentina
State/province [28] 0 0
Rosario
Country [29] 0 0
Austria
State/province [29] 0 0
Innsbruck
Country [30] 0 0
Austria
State/province [30] 0 0
Linz
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belarus
State/province [32] 0 0
Brestskaya Voblasts'
Country [33] 0 0
Belarus
State/province [33] 0 0
Vitsyebskaya Voblasts'
Country [34] 0 0
Belarus
State/province [34] 0 0
Minsk
Country [35] 0 0
Belgium
State/province [35] 0 0
Brugge
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Edegem
Country [38] 0 0
Belgium
State/province [38] 0 0
Eeklo
Country [39] 0 0
Belgium
State/province [39] 0 0
Roeselare
Country [40] 0 0
Brazil
State/province [40] 0 0
AP
Country [41] 0 0
Brazil
State/province [41] 0 0
BA
Country [42] 0 0
Brazil
State/province [42] 0 0
RJ
Country [43] 0 0
Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
SP
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Pleven
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Sofia
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Croatia
State/province [51] 0 0
Varazdin
Country [52] 0 0
Croatia
State/province [52] 0 0
Zagreb
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno
Country [54] 0 0
Czechia
State/province [54] 0 0
Havirov
Country [55] 0 0
Czechia
State/province [55] 0 0
Hradec Kralove
Country [56] 0 0
Czechia
State/province [56] 0 0
Jihlava
Country [57] 0 0
Czechia
State/province [57] 0 0
Pardubice
Country [58] 0 0
Czechia
State/province [58] 0 0
Praha 2
Country [59] 0 0
Czechia
State/province [59] 0 0
Teplice
Country [60] 0 0
Estonia
State/province [60] 0 0
Tallinn
Country [61] 0 0
Estonia
State/province [61] 0 0
Tartu
Country [62] 0 0
Finland
State/province [62] 0 0
Tampere
Country [63] 0 0
France
State/province [63] 0 0
Bordeaux
Country [64] 0 0
France
State/province [64] 0 0
Bron
Country [65] 0 0
France
State/province [65] 0 0
Caen
Country [66] 0 0
France
State/province [66] 0 0
Clermont Ferrand
Country [67] 0 0
France
State/province [67] 0 0
Lille
Country [68] 0 0
France
State/province [68] 0 0
Nancy
Country [69] 0 0
France
State/province [69] 0 0
Nantes
Country [70] 0 0
France
State/province [70] 0 0
Nice
Country [71] 0 0
France
State/province [71] 0 0
Poissy
Country [72] 0 0
France
State/province [72] 0 0
Strasbourg
Country [73] 0 0
Germany
State/province [73] 0 0
Bayreuth
Country [74] 0 0
Germany
State/province [74] 0 0
Berlin
Country [75] 0 0
Germany
State/province [75] 0 0
Bonn
Country [76] 0 0
Germany
State/province [76] 0 0
Dresden
Country [77] 0 0
Germany
State/province [77] 0 0
Dusseldorf
Country [78] 0 0
Germany
State/province [78] 0 0
Essen
Country [79] 0 0
Germany
State/province [79] 0 0
Frankfurt
Country [80] 0 0
Germany
State/province [80] 0 0
Gießen
Country [81] 0 0
Germany
State/province [81] 0 0
Leipzig
Country [82] 0 0
Germany
State/province [82] 0 0
Mittweida
Country [83] 0 0
Germany
State/province [83] 0 0
Muenster
Country [84] 0 0
Germany
State/province [84] 0 0
München
Country [85] 0 0
Germany
State/province [85] 0 0
Regensburg
Country [86] 0 0
Germany
State/province [86] 0 0
Tuebingen
Country [87] 0 0
Germany
State/province [87] 0 0
Ulm
Country [88] 0 0
Germany
State/province [88] 0 0
Westerstede
Country [89] 0 0
Hungary
State/province [89] 0 0
Budapest
Country [90] 0 0
Hungary
State/province [90] 0 0
Pecs
Country [91] 0 0
Israel
State/province [91] 0 0
Jerusalem
Country [92] 0 0
Israel
State/province [92] 0 0
Petach Tiqwa
Country [93] 0 0
Israel
State/province [93] 0 0
Ramat Gan
Country [94] 0 0
Israel
State/province [94] 0 0
Ramat-Gan
Country [95] 0 0
Israel
State/province [95] 0 0
Tel Aviv
Country [96] 0 0
Italy
State/province [96] 0 0
Lazio
Country [97] 0 0
Italy
State/province [97] 0 0
Liguria
Country [98] 0 0
Italy
State/province [98] 0 0
Lombardia
Country [99] 0 0
Italy
State/province [99] 0 0
Marche
Country [100] 0 0
Italy
State/province [100] 0 0
Piemonte
Country [101] 0 0
Italy
State/province [101] 0 0
Sicilia
Country [102] 0 0
Italy
State/province [102] 0 0
Valle D?Aosta
Country [103] 0 0
Latvia
State/province [103] 0 0
R?ga
Country [104] 0 0
Latvia
State/province [104] 0 0
Riga
Country [105] 0 0
Lithuania
State/province [105] 0 0
Kaunas
Country [106] 0 0
Lithuania
State/province [106] 0 0
Klaipeda
Country [107] 0 0
Lithuania
State/province [107] 0 0
Vilnius
Country [108] 0 0
Mexico
State/province [108] 0 0
Mexico CITY (federal District)
Country [109] 0 0
Mexico
State/province [109] 0 0
Nuevo LEON
Country [110] 0 0
Mexico
State/province [110] 0 0
Sinaloa
Country [111] 0 0
Mexico
State/province [111] 0 0
Aguascalientes
Country [112] 0 0
Mexico
State/province [112] 0 0
Chihuahua
Country [113] 0 0
Netherlands
State/province [113] 0 0
Sittard-Geleen
Country [114] 0 0
New Zealand
State/province [114] 0 0
Hamilton
Country [115] 0 0
Norway
State/province [115] 0 0
Bergen
Country [116] 0 0
Poland
State/province [116] 0 0
Bydgoszcz
Country [117] 0 0
Poland
State/province [117] 0 0
Gda?sk
Country [118] 0 0
Poland
State/province [118] 0 0
Katowice
Country [119] 0 0
Poland
State/province [119] 0 0
Krakow
Country [120] 0 0
Poland
State/province [120] 0 0
Lodz
Country [121] 0 0
Poland
State/province [121] 0 0
Lublin
Country [122] 0 0
Poland
State/province [122] 0 0
Olsztyn
Country [123] 0 0
Poland
State/province [123] 0 0
Plewiska
Country [124] 0 0
Poland
State/province [124] 0 0
Siemianowice ?l?skie
Country [125] 0 0
Poland
State/province [125] 0 0
Warszawa
Country [126] 0 0
Portugal
State/province [126] 0 0
Almada
Country [127] 0 0
Portugal
State/province [127] 0 0
Braga
Country [128] 0 0
Portugal
State/province [128] 0 0
Coimbra
Country [129] 0 0
Portugal
State/province [129] 0 0
Lisboa
Country [130] 0 0
Romania
State/province [130] 0 0
Bucuresti
Country [131] 0 0
Romania
State/province [131] 0 0
Campulung
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Altaj
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Mordovija
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Moskovskaja Oblast
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Niznij Novgorod
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Sankt Petersburg
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Stavropol
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Sverdlovsk
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Tjumen
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Vologda
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Kemerovo
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Kirov
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Novosibirsk
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Perm
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Samara
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Smolensk
Country [147] 0 0
Serbia
State/province [147] 0 0
Kragujevac
Country [148] 0 0
Serbia
State/province [148] 0 0
NIS
Country [149] 0 0
Slovakia
State/province [149] 0 0
Banska Bystrica
Country [150] 0 0
Slovakia
State/province [150] 0 0
Bratislava
Country [151] 0 0
Slovakia
State/province [151] 0 0
Zilina
Country [152] 0 0
Spain
State/province [152] 0 0
Barcelona
Country [153] 0 0
Spain
State/province [153] 0 0
Girona
Country [154] 0 0
Spain
State/province [154] 0 0
LA Coruña
Country [155] 0 0
Spain
State/province [155] 0 0
Madrid
Country [156] 0 0
Spain
State/province [156] 0 0
Sevilla
Country [157] 0 0
Spain
State/province [157] 0 0
Vizcaya
Country [158] 0 0
Spain
State/province [158] 0 0
Malaga
Country [159] 0 0
Sweden
State/province [159] 0 0
Mölnlycke
Country [160] 0 0
Sweden
State/province [160] 0 0
Solna
Country [161] 0 0
Sweden
State/province [161] 0 0
Stockholm
Country [162] 0 0
Switzerland
State/province [162] 0 0
Basel
Country [163] 0 0
Switzerland
State/province [163] 0 0
Lugano
Country [164] 0 0
Tunisia
State/province [164] 0 0
Mannouba
Country [165] 0 0
Tunisia
State/province [165] 0 0
Monastir
Country [166] 0 0
Turkey
State/province [166] 0 0
Istanbul
Country [167] 0 0
Turkey
State/province [167] 0 0
Samsun
Country [168] 0 0
Turkey
State/province [168] 0 0
Trabzon
Country [169] 0 0
Ukraine
State/province [169] 0 0
Chernihiv Governorate
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kharkiv Governorate
Country [171] 0 0
Ukraine
State/province [171] 0 0
KIEV Governorate
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Exeter
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Liverpool
Country [174] 0 0
United Kingdom
State/province [174] 0 0
London
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Newcastle upon Tyne
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Nottingham
Country [177] 0 0
United Kingdom
State/province [177] 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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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/NCT05269004