OleroMAX
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)
Baseline up to 5 years
Walking and mobilityArm and hand functionQuality of life (reported by participants)Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study
Up to 5 years
Other measures (4)
Number of Participants With Serious Adverse Events (SAEs)
Up to 5 years
SafetyNumber of Participants With Adverse Events (AEs) Leading to Discontinuation
Up to 5 years
SafetyNumber of Participants With Adverse Events of Special Interest (AESIs)
Up to 5 years
Safety1. The incidence, nature, severity and outcome of serious adverse events, adverse events leading to discontinuation, and adverse events of special interest
Safety
Who could take part
MS (type not specified) · 18 and over
Inclusion Criteria: * Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies [Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)] at the time of roll-over and who do not have access to the ocrelizumab treatment locally * The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study * Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential Exclusion Criteria: * Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant * Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant * Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) * Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications * Concurrent participation in any therapeutic clinical trial (other than the parent study) * Immunocompromised state * Known active malignancy or are being actively monitored for recurrence of malignancy * Known presence of other neurological disorders
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.
Loading reviews and guidelines…
Linked trials
Extension of
Ocarina IIPhase 3 · Completed
Extension of
GAVOTTEPhase 3 · Running, not recruiting
Extension of
MUSETTEPhase 3 · Running, not recruiting
Extension of
A Study To Investigate The Pharmacokinetics, Safety, And …Phase 1 · Completed
Extension of
FENtrepidPhase 3 · Running, not recruiting
Extension of
O'HANDPhase 3 · Running, not recruiting
Extension of
CONSONANCEPhase 3 · Running, not recruiting
Extension of
OLEROPhase 3 · Running, not recruiting
Links found where a registry record names another trial's registry number.
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Status unknown
No result found
History
Started
Dec 2024
Main results due
Dec 2029
Finished
Dec 2029
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