Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:3/27/2019
Start Date:April 4, 2017
End Date:February 22, 2024
Contact:Reference Study ID: MA30143 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S and Canada)

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An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates
effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will
consist of an open-label treatment period of 192 weeks and follow-up period of at least 48
weeks.


Inclusion Criteria:

- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria

- Have a length of disease duration, from first documented clinical attack consistent
with MS disease of less than or equal to (
- Within the last 12 months one or more clinically reported relapse(s) or one or more
signs of MRI activity

- EDSS of 0.0 to 3.5 inclusive, at screening

- An agreement to use an acceptable birth control method for women of childbearing
potential, during the treatment period and for at least 6 months after the last dose
of study drug

Exclusion Criteria:

- Secondary progressive multiple sclerosis or history of primary progressive or
progressive relapsing MS

- Inability to complete an MRI

- Known presence of other neurological disorders

Exclusions Related to General Health:

- Pregnancy or lactation

- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study

- History or currently active primary or secondary immunodeficiency

- Lack of peripheral venous access

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

- Significant or uncontrolled somatic disease or any other significant disease that may
preclude participant from participating in the study

- Congestive heart failure (New York Heart Association III or IV functional severity)

- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
(excluding fungal infection of nail beds) or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or
oral antibiotics 2 weeks prior to screening

- History of malignancy, major opportunistic infections, alcohol or drug abuse,
recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

- Received any prior approved disease modifying treatment (DMT) with a label for MS, for
example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab,
fingolimod, teiflunomide and dimethylfumarate

- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the
baseline visit

- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab,
atacicept, belimumab, or ofatumumab)

- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic
therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine,
methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone
marrow transplantation)

- Treatment with investigational DMT

- Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to
screening
We found this trial at
31
sites
2010 East 90th Street
Cleveland, Ohio 44195
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Atlanta, Georgia 30309
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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22 South Greene Street
Baltimore, Maryland 21201
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Baton Rouge, Louisiana 70810
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1305 Airport Freeway
Bedford, Texas 76021
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3400 Uspallata
Buenos Aires, C1437
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Cordova, Tennessee 38018
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Dayton, Ohio
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2121 East Harmony Road
Fort Collins, Colorado 80528
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16 Chestnut Street
Foxboro, Massachusetts 02035
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Golden Valley, Minnesota 55422
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
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Maitland, Florida 32751
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Milwaukee, WI
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Overland Park, Kansas 66210
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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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Plainview, New York 11803
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Scarborough, Maine 04074
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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301 Old San Francisco Rd
Sunnyvale, California 94086
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Tacoma, WA
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12912 USF Health Drive
Tampa, Florida 33612
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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110 Cedar Street
Wellesley, Massachusetts 02481
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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