Consonance - AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS

 This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Drug: Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)

NCT03523858
Neuroscience - Multiple Sclerosis, Neuroscience
Pavle Repovic, MD
Yuriko Courtney

Inclusion Criteria:

  • Have a length of disease duration since Progressive Multiple Sclerosis (PMS) disease symptom onsent <= 10 years if baseline Expanded Disability Status Scale (EDSS) <=5.0 and <=15 years if baseline EDSS >5.0
  • Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers.
  • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug.
  • EDSS (Expanded Disability Status Scale) ≤6.5 at screening
  • Have a documented evidence of disability progression independent of relapse at any point in time over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment

Exclusion Criteria:

  • Gadolinium (Gd) intolerance
  • Known presence of other neurological disorders Exclusions Related to General Health
  • Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
  • Active infections must be treated and resolved before possible inclusion in the study.
  • Participants in a severely immunocompromised state until the condition resolves
  • Participants with known active malignancies or being actively monitored for recurrence of malignancy
  • Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)

Exclusions Related to Medications

  • All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted.
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five halflives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
  • Previous treatment with B-cell targeted therapies, alemtuzumab, total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab, daclizumab or figolimod in the last 8 weeks.
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
  • Participants previously treated with teriflunomide, unless an accelerated elimination procedure is implemented until its completion before screening visit
  • Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks.
  • Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks.
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
  • Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening.
Yuriko Courtney
206-320-3070