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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
Date last updated
12/06/2024

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
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
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
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United States of America
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Arizona
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California
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Mannouba
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Monastir
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Turkey
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Samsun
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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 Phase IIIb, single-arm, multicenter, OLE study. 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) are eligible for enrollment in this extension study. 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.
Trial website
https://clinicaltrials.gov/study/NCT05269004
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