A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis (CONSONANCE)
- Study HIC#:2000024074
- Last Updated:07/15/2021
This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).
- Age18 years - 65 years
- Start Date05/18/2021
- End Date09/29/2023
Trial Purpose and Description
To evaluate the effectiveness of ocrelizumab treatment in patients with PMS disease course
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
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.