Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Ocrelizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ocrelizumab<br>Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care. | Drug: Ocrelizumab<br>* Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.<br>* Other names: Ocrevus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the overall SymptoMScreen score in participants with RMS | SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities) | 4 years | 
| Changes in the overall SymptoMScreen score in participants with PPMS | SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of RMS Participants with Adverse Events |  | 4 years | 
| Percentage of PPMS participants with Adverse Events |  | 4 years | 
| Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS |  | 4 years | 
| Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS |  | 4 years | 
| Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants |  | 4 years | 
| Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants |  | 4 years | 
| 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 | 
| Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants |  | 4 years | 
| Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants |  | 4 years | 
| Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants |  | 4 years | 
| Change in the score of MSWS - 12 scale in RMS participants |  | 4 years | 
| Change in the score of MSWS - 12 scale in PPMS participants |  | 4 years | 
| Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants |  | 4 years | 
| Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants |  | 4 years | 
| Frequency of relapses over time in RMS patients |  | 4 years | 
| Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time |  | 4 years | 
| Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time |  | 4 years |