Impact of ocrelizumab on patient-reported fatigue and quality of life in patients with relapsing multiple sclerosis treated for the first time with ocrelizumab

Impact of ocrelizumab on patient-reported fatigue and quality of life in relapsing multiple sclerosis patients treated for the first time with ocrelizumab (MoOzaRt): an observational study

  • Multiple Sclerosis (MS)
Trial Status:

Recruiting

This trial runs in
Countries
  • Germany
Trial Identifier:

ML42393

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      Relapsed multiple sclerosis (RMS) is a complex disease in which the insulating layer of nerves (the myelin layer) breaks down and disturbs communication between nerve cells. The aim of this study is to collect data on initial treatment with Ocrevus® from the routine care of patients with RMS and to analyze it.

       

      Ocrevus® is used to treat RMS and early primary progressive multiple sclerosis (PPMS) in adult patients. Ocrevus® contains the active ingredient ocrelizumab. It is a specific type of protein called a monoclonal antibody. Antibodies work by attaching themselves to bind certain targets in the body. Ocrevus® binds to certain B cells, a type of white blood cell that is part of the immune system and plays a role in multiple sclerosis. Ocrevus® targets these specific B cells and removes them. This reduces inflammatory processes and attacks on the myelin layer, making relapse less likely to occur and slowing disease progression. Knowledge of this medicinal product can be expanded in patients with RMS and may influence long-term treatment with Ocrevus®.

      Roche Pharma AG (Germany), Roche Pharma (Schweiz) AG (Switzerland) Sponsor
      ML42393 Trial Identifier
      Both Gender
      between 18 Years and 65 Years Age
      No Healthy Volunteers

      Who can participate?
      Patients aged between 18 years and 65 years with relapsed multiple sclerosis being treated with ocrelizumab (Ocrevus®) for the first time

      What does the study involve?
      The following data will be collected over a period of 2 years:

      1. Demographic data: year of birth, gender
      2. Employment level
      3. Medical history and other illnesses, including medical and surgical history
      4. History of MS disease and treatment
      5. Date of first symptoms of MS and type of symptoms
      6. Date of MS diagnosis and type of symptoms at diagnosis
      7. Confirmation of the RMS diagnosis
      8. Number of relapses per year within the last 3 years
      9. All previous MS treatments and therapies, including duration and the main reason for discontinuation (if any)
      10. MS status before the start of treatment
      11. Magnetic resonance imaging (MRI) results within the last 12 months
      12. All previous and accompanying immunomodulatory and immunosuppressive treatments including their duration
      13. Any previous and accompanying medication to treat tiredness and/or depression including its dose
      14. Any previous and accompanying medication within the last 3 months, especially drugs that can cause fatigue (e.g. antihistamines)
      15. Supplements to previous and accompanying immunomodulatory and immunosuppressive treatments including their duration
      16. MS symptoms, relapses, MS type, as well as MS status and MRI since the last visit (if present)
      17. Physical and mental activities (e.g. endurance and strength training)
      18. State of health (e.g. smoking habits)
      19. Vital signs (blood pressure, heart rate, body temperature), height and weight
      20. Laboratory values: blood tests (blood count, chemistry, immunoglobulins, kidney values), data on certain immune cells (B-cell status), data on the menopause status, test for bacterial and viral infections
      21. Treatment with Ocrevus® (dose, duration of infusion, type of pre-medication)
      22. Questionnaire to assess the severity of the permanently increased exhaustion before the premedication of Ocrevus®
      23. Evaluation of the severity of the daily form-dependent increased exhaustion before the premedication, after the pre-medication, after the Ocrevus® infusion, 2 days after the infusion (at home), and 3 months after the infusion (at home)
      24. Questionnaire on the influence that multiple sclerosis has on everyday life
      25. Questionnaire on impairment of work productivity and activity
      26. Questionnaire to assess anxiety and depression in patients with physical diseases
      27. Questionnaire for recording mental deficits
      28. Serious and non-serious adverse events after the first dose of Ocrevus®, as well as reactions that occur with the procedure of infusion in related adverse events of special interest (i.e. cases of drug-induced liver damage, suspected transmission of infectious material through the study medication)
      29. Date of last contact with the attending doctor

       

      What are the possible benefits and risks of participating?
      Research projects have confidentiality risks (e.g. the possibility of identifying the participant). There is no benefit to participants from providing this data, but the findings from this study may be used to improve long-term treatment with Ocrevus® in the future.

      Where is the study run from?
      Katholisches Klinikum Lünen/Werne GmbH (Germany)

      When is the study starting and how long is it expected to run for?
      November 2020 to October 2025

      Who is funding the study?

      1. Roche Pharma AG (Germany)
      2. Roche Pharma (Schweiz) AG (Switzerland)

       

      Who is the main contact?
      global-roche-genentech-trials@gene.com

      Trial Summary

      Relapsed multiple sclerosis (RMS) is a complex disease in which the insulating layer of nerves (the myelin layer) breaks down and disturbs communication between nerve cells. The aim of this study is to collect data on initial treatment with Ocrevus® from the routine care of patients with RMS and to analyze it.

       

      Ocrevus® is used to treat RMS and early primary progressive multiple sclerosis (PPMS) in adult patients. Ocrevus® contains the active ingredient ocrelizumab. It is a specific type of protein called a monoclonal antibody. Antibodies work by attaching themselves to bind certain targets in the body. Ocrevus® binds to certain B cells, a type of white blood cell that is part of the immune system and plays a role in multiple sclerosis. Ocrevus® targets these specific B cells and removes them. This reduces inflammatory processes and attacks on the myelin layer, making relapse less likely to occur and slowing disease progression. Knowledge of this medicinal product can be expanded in patients with RMS and may influence long-term treatment with Ocrevus®.

      Roche Pharma AG (Germany), Roche Pharma (Schweiz) AG (Switzerland) Sponsor
      ML42393 Trial Identifier
      Ocrelizumab Treatments
      Multiple sclerosis Condition
      Official Title

      Impact of ocrelizumab on patient-reported fatigue and quality of life in relapsing multiple sclerosis patients treated for the first time with ocrelizumab (MoOzaRt): an observational study

      Eligibility Criteria

      Both Gender
      between 18 Years and 65 Years Age
      No Healthy Volunteers

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