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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 : Recruiting
First Posted : July 20, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Ocrelizumab

Study Design
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Study Type : Observational
Estimated Enrollment : 1250 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 2, 2018
Estimated Primary Completion Date : July 18, 2025
Estimated Study Completion Date : July 18, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ocrelizumab
Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
 Drug: Ocrelizumab
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Other Name: Ocrevus


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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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
Study Population
Participants with RMS or PPMS undergoing routine clinical care
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Reference Study ID Number: MN39889 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03593590     History of Changes
Other Study ID Numbers: MN39889
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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