A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

  • Interventional
  • Recruiting
  • NCT03523858
Eligibility Details Visit Clinicaltrials.gov

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).

Gender
All

Age Group
18 Years to 65 Years

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03523858

IRB#IRB18-1280

Lead SponsorHoffmann-La Roche

Lead PhysicianAnthony T. Reder

Collaborator(s)N/A

EligibilityAll
18 Years to 65 Years
Recruiting