CompletedRelapsing and progressiveNCT03593590

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

What it measured

Main measures

  • Changes in the overall SymptoMScreen score in participants with RMS

    4 years

    VisionThinking and memoryFatigueWalking and mobilityArm and hand functionBladder, bowel and sexual functionPainMood and sleep
  • Changes in the overall SymptoMScreen score in participants with PPMS

    4 years

    VisionThinking and memoryFatigueWalking and mobilityArm and hand functionBladder, bowel and sexual functionPainMood and sleep

Other measures (19)

  • Percentage of RMS Participants with Adverse Events

    4 years

    Safety
  • Percentage of PPMS participants with Adverse Events

    4 years

    Safety
  • Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS

    4 years

    Safety
  • Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS

    4 years

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

    4 years

    Quality of life (reported by participants)
  • Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants

    4 years

    Quality of life (reported by participants)
  • Change in the score of ABILHAND - 56 scale in RMS participants

    4 years

  • Change in the score of ABILHAND - 56 scale in PPMS participants

    4 years

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

    4 years

    Thinking and memoryFatigue
  • Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants

    4 years

    Thinking and memoryFatigue

Who could take part

Relapsing and progressive · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2018

      2. Main results due

        Jan 2026

      3. Finished

        Jan 2026

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