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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	27 February 2024
Main ID:	NCT03593590
Date of registration:	11/07/2018
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis MuSicalE
Scientific 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
Date of first enrolment:	November 12, 2018
Target sample size:	1710
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03593590
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Austria	Belgium	Brazil	Bulgaria	Chile	Colombia	Dominican Republic	Egypt
Israel	Italy	Kuwait	Montenegro	Netherlands	Panama	Paraguay	Poland
Portugal	Qatar	Romania	Russian Federation	Saudi Arabia	Serbia	Slovakia	Spain
Turkey	United Arab Emirates	United Kingdom

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

Changes in the overall SymptoMScreen score in participants with PPMS [Time Frame: 4 years]

Changes in the overall SymptoMScreen score in participants with RMS [Time Frame: 4 years]

Secondary Outcome(s)

Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS [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 Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants [Time Frame: 4 years]

Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time [Time Frame: 4 years]

Frequency of relapses over time in RMS patients [Time Frame: 4 years]

Percentage of PPMS participants with Adverse Events [Time Frame: 4 years]

Change in the score of MSWS - 12 scale 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 Treatment Satisfaction Questionnaire for Medication (TSQM) 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]

Percentage of RMS Participants with Adverse Events [Time Frame: 4 years]

Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) 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 RMS Participants [Time Frame: 4 years]

Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time [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 ABILHAND - 56 scale in PPMS participants [Time Frame: 4 years]

Change in the score of MSWS - 12 scale in PPMS participants [Time Frame: 4 years]

Change in the score of ABILHAND - 56 scale in RMS participants [Time Frame: 4 years]

Secondary ID(s)

MN39889

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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