Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis

  • Autoimmune Disorder
  • Multiple Sclerosis (MS)
  • Relapsing-Remitting Multiple Sclerosis (RRMS)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Not yet recruiting

This trial runs in
Trial Identifier:

NCT05949580 MN44358

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      Trial Summary

      The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice. This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT05949580, MN44358 Trial Identifier
      MS Care Platform (icobrain ms and icompanion ms) Treatments
      Relapsing Remitting Multiple Sclerosis Condition
      Official Title

      Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
      • Have a valid email address (for registration of icompanion ms)
      • Have a definite diagnosis of RRMS
      • Time since MS diagnosis ≥1 year
      • Medical history recorded for at least 1 year before enrollment
      • Expanded Disability Status Scale (EDSS) <5.5
      Exclusion Criteria
      • Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
      • Inability to complete an MRI
      • Currently involved in an interventional trial
      • Diagnosis of progressive MS (primary progressive multiple sclerosis [PPMS] or secondary progressive multiple sclerosis [SPMS])

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