MuSicalE
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Changes in the overall SymptoMScreen score in participants with RMS
4 years
VisionThinking and memoryFatigueWalking and mobilityArm and hand functionBladder, bowel and sexual functionPainMood and sleepChanges in the overall SymptoMScreen score in participants with PPMS
4 years
VisionThinking and memoryFatigueWalking and mobilityArm and hand functionBladder, bowel and sexual functionPainMood and sleep
Other measures (19)
Percentage of RMS Participants with Adverse Events
4 years
SafetyPercentage of PPMS participants with Adverse Events
4 years
SafetyTime to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS
4 years
SafetyTime to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS
4 years
SafetyChange in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants
4 years
Quality of life (reported by participants)Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants
4 years
Quality of life (reported by participants)Change in the score of ABILHAND - 56 scale in RMS participants
4 years
Change in the score of ABILHAND - 56 scale in PPMS participants
4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant
4 years
Thinking and memoryFatigueChange in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants
4 years
Thinking and memoryFatigue
Who could take part
Relapsing and progressive · 18 and over
Inclusion Criteria: * Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice * Must be prescribed ocrelizumab in line with the SmPC * Must have provided signed informed consent * Must be able and willing to complete the PROs as per clinical practice Exclusion Criteria: * Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design) * Not receiving ocrelizumab in line with the SmPC
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2018
Main results due
Jan 2026
Finished
Jan 2026
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