Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Emmanuelle Waubant
Photo of Emmanuelle Waubant
Emmanuelle Waubant

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) Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Ocrelizumab

Eligibility

You can join if…

Open to people ages 18-65

  • Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
  • EDSS (Expanded Disability Status Scale) </ =6.5 at screening
  • 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 a documented evidence of disability progression independent of relapse at any point 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
  • Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
  • Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

You CAN'T join if...

  • Relapsing-remitting multiple sclerosis (RRMS) at screening
  • Inability to complete an MRI
  • Gadolinium (Gd) intolerance
  • Known presence of other neurological disorders

Exclusions Related to General Health:

  • Positive screening tests for hepatitis B
  • Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
  • Lactation
  • 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
  • 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:

  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, tabalumab, belimumab, ofatumumab, or obinutizumab)
  • Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • 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
  • Previous treatment with daclizumab or figolimod in the last 8 weeks
  • Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening
  • Previous treatment with natalizumab in the last 12 weeks
  • Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
  • Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks
  • Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

Exclusions for Participants in the Optical Coherence Tomography (OCT) Assessments:

  • Participants with clinically relevant ocular pathologies, potentially interfering with clinical and instrumental evaluations

Exclusions for Participants Participating in the Measurement of Motor Evoked Potentials:

  • History of seizures
  • Prior craniotomy or skull fracture
  • Movable metallic implant in the head
  • Implanted stimulators (e.g. cochlear implant or cardiac pacemaker, deep brain stimulator)
  • Known history of high intracranial pressure

Locations

  • University of California San Francisco in progress, not accepting new patients
    San Francisco California 94117 United States
  • SC3 Research Group, Inc in progress, not accepting new patients
    Pasadena California 91105 United States

Lead Scientist at UCSF

  • Emmanuelle Waubant
    Dr Waubant trained as a neurologist in Toulouse, France. She continued her training as a neuroimmunology fellow in Dr Stephen Hauser’s UCSF laboratory, focusing on matrix metalloproteinases (MMP) and their tissue inhibitors (TIMP), and their role in migration of lymphocytes through equivalents of the blood-brain barrier.

Details

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