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



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:3/27/2019
Start Date:May 28, 2018
End Date:August 21, 2025
Contact:Reference Study ID Number: MN39159 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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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).


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.
We found this trial at
19
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Algiers,
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Boston, MA
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Chicago, IL
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Cincinnati, OH
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Cleveland, Ohio 44195
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Cordova, Tennessee 38018
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Detroit, MI
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Latham, NY
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New Haven, Connecticut 06473
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Newport Beach, California 92663
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Pasadena, California 91105
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Round Rock, TX
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78258
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San Francisco, California 94143
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Seattle, Washington 98122
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Wellesley, Massachusetts 02481
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