OLERO
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
Up to 44 months
Safety1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Safety
Other measures (6)
Change in Expanded Disability Status Scale (EDSS) score over time
Week 0, 24, 48, 72, 96, 120, 168
Disability progressionChange in 9-Hole Peg Test (9HPT) over time
Week 0, 24, 48, 72, 96, 120, 168
Disability progressionChange in Timed 25-Foot Walk Test (T25FWT) over time
Week 0, 24, 48, 72, 96, 120, 168
Disability progressionWalking and mobilityThe number of T1 lesions and number of new or enlarging T2 lesions
Week 0, 24, 48, 72, 96, 120, 168
MRI lesionsThe change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
Week 0, 24, 48, 72, 96, 120, 168
MRI lesions2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time
Disability progressionWalking and mobility
Who could take part
Relapsing and progressive · 18 to 64
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 Exclusion criteria * Concurrent participation in any clinical trial (other than the Parent study) * Unable or unwilling to comply with the requirements of the protocol
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Linked trials
Extended by
OleroMAXPhase 3 · Recruiting
Links found where a registry record names another trial's registry number.
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History
Started
May 2022
Main results due
Dec 2027
Finished
Dec 2027
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