Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis (MuSicalE)
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ClinicalTrials.gov Identifier: NCT03593590 |
Recruitment Status :
Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : August 23, 2022
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Condition or disease | Intervention/treatment |
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Multiple Sclerosis | Drug: Ocrelizumab |
Study Type : | Observational |
Estimated Enrollment : | 1700 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | November 12, 2018 |
Estimated Primary Completion Date : | July 26, 2025 |
Estimated Study Completion Date : | July 26, 2025 |

Group/Cohort | Intervention/treatment |
---|---|
Ocrelizumab
Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
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Drug: Ocrelizumab
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Other Name: Ocrevus |
- Changes in the overall SymptoMScreen score in participants with RMS [ Time Frame: 4 years ]
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)
- Changes in the overall SymptoMScreen score in participants with PPMS [ Time Frame: 4 years ]
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)
- Percentage of RMS Participants with Adverse Events [ Time Frame: 4 years ]
- Percentage of PPMS participants with Adverse Events [ Time Frame: 4 years ]
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS [ Time Frame: 4 years ]
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS [ Time Frame: 4 years ]
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants [ Time Frame: 4 years ]
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants [ Time Frame: 4 years ]
- Change in the score of ABILHAND - 56 scale in RMS participants [ Time Frame: 4 years ]
- Change in the score of ABILHAND - 56 scale in PPMS participants [ Time Frame: 4 years ]
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant [ Time Frame: 4 years ]
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants [ Time Frame: 4 years ]
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants [ Time Frame: 4 years ]
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants [ Time Frame: 4 years ]
- Change in the score of MSWS - 12 scale in RMS participants [ Time Frame: 4 years ]
- Change in the score of MSWS - 12 scale in PPMS participants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 years ]
- Frequency of relapses over time in RMS patients [ Time Frame: 4 years ]
- Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time [ Time Frame: 4 years ]
- Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time [ Time Frame: 4 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593590

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03593590 |
Other Study ID Numbers: |
MN39889 |
First Posted: | July 20, 2018 Key Record Dates |
Last Update Posted: | August 23, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Ocrelizumab Immunologic Factors Physiological Effects of Drugs |