Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis
- Registration Number
- NCT03593590
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1710
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
- Primary Outcome Measures
Name Time Method Changes in the overall SymptoMScreen score in participants with RMS 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 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
Name Time Method Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS 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 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 PPMS participants 4 years Change in the score of MSWS - 12 scale in RMS 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 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 Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time 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 Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time 4 years Change in the score of ABILHAND - 56 scale in RMS participants 4 years Percentage of RMS Participants with Adverse Events 4 years Frequency of relapses over time in RMS patients 4 years
Trial Locations
- Locations (160)
Landesklinikum Amstetten
🇦🇹Amstetten, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus
🇦🇹Linz, Austria
Kepler Universitätskliniken GmbH - Med Campus III
🇦🇹Linz, Austria
Multiple Sklerose Zentrum
🇦🇹Melk, Austria
Klinik Floridsdorf
🇦🇹Wien, Austria
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
AZ KLINA
🇧🇪Brasschaat, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
Hospital Erasme
🇧🇪Bruxelles, Belgium
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