Summary

for people ages 18-65 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

Keywords

Progressive Multiple Sclerosis (PMS) Sclerosis Multiple Sclerosis Ocrelizumab

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94117 United States
  • SC3 Research Group, Inc accepting new patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03523858
Phase
Phase 3
Study Type
Interventional
Last Updated