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Completed

NCT Number: NCT03593590

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landesklinikum Amstetten, Amstetten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.

Other names: Ocrevus

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Percentage of RMS Participants with Adverse Events

    Time frame: 4 years

  2. Percentage of PPMS participants with Adverse Events

    Time frame: 4 years

  3. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS

    Time frame: 4 years

  4. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS

    Time frame: 4 years

  5. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants

    Time frame: 4 years

  6. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants

    Time frame: 4 years

  7. Change in the score of ABILHAND - 56 scale in RMS participants

    Time frame: 4 years

  8. Change in the score of ABILHAND - 56 scale in PPMS participants

    Time frame: 4 years

  9. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant

    Time frame: 4 years

  10. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants

    Time frame: 4 years

  11. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants

    Time frame: 4 years

  12. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants

    Time frame: 4 years

  13. Change in the score of MSWS - 12 scale in RMS participants

    Time frame: 4 years

  14. Change in the score of MSWS - 12 scale in PPMS participants

    Time frame: 4 years

  15. 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

  16. 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

  17. Frequency of relapses over time in RMS patients

    Time frame: 4 years

  18. Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time

    Time frame: 4 years

  19. Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: MuSicalE

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2018
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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