NIS MoOzaRt

Treatment tested

• Ocrelizumab

  B-lymphocyte antigen CD20 binding agent

Other measures (1)

Inclusion: Current inclusion criteria as of 03/12/2024: 1. Diagnosis of MS 2. RMS participants, diagnosed by revised McDonald criteria 3. First-time treatment during the course of MS therapy with ocrelizumab according to the local label, regardless of the reason for starting treatment with ocrelizumab (participants may switch to the shorter IV infusion or SC injection within the study) _____ Previous inclusion criteria: 1. Diagnosis of MS 2. RMS patients, diagnosed by revised McDonald criteria 3. First-time treatment during the course of MS therapy with ocrelizumab according to the local label, regardless of the reason for starting treatment with ocrelizumab (patients may switch to the shorter infusion within the study) Exclusion: 1. Off-label use of ocrelizumab 2. Participation in interventional studies investigating disease-modifying therapies for MS or in NIS Confidence (ML39632) 3. Severe psychiatric disability 4. Previous treatment with anti-CD20 antibodies 5. Pregnant and/or breastfeeding

Background and study aims 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. This study aims 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®. 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. MS symptoms, relapses, MS type, as well as MS status and MRI since the last visit (if present) 16. Physical and mental activities (e.g. endurance and strength training) 17. State of health (e.g. smoking habits) 18. Vital signs (blood pressure, heart rate, body temperature), height and weight 19. 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 20. Treatment with Ocrevus® (dose, duration of infusion, type of pre-medication) 21. Questionnaire to assess the severity of the permanently increased exhaustion before the premedication of Ocrevus® 22. 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) 23. Questionnaire on the influence that multiple sclerosis has on everyday life 24. Questionnaire on impairment of work productivity and activity 25. Questionnaire to assess anxiety and depression in participants with physical diseases 26. Questionnaire for recording mental deficits 27. 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) 28. Date of last contact with the attending doctor 29. To assess the impact of any digital health applications (DiGA) app use on fatigue (not applicable for participants in Switzerland) 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 June 2026 Who is funding the study? 1. Roche Pharma AG (Germany) 2. Roche Pharma (Schweiz) AG (Switzerland)