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

N/AActive Not RecruitingNCT03593590

Hoffmann-La Roche1,710 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,710

Conditions

Multiple Sclerosis

Interventions

OcrelizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Changes in the overall SymptoMScreen score in participants with RMS

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)

Time frame: 4 years

Changes in the overall SymptoMScreen score in participants with PPMS

Time frame: 4 years

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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