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
Cordova, Tennessee 38018
497
mi
from 43215
Cordova, TN
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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...
333
mi
from 43215
Nashville, TN
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
1637
mi
from 43215
Tucson, AZ
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Atlanta, Georgia 30309
432
mi
from 43215
Atlanta, GA
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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...
1154
mi
from 43215
Aurora, CO
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22 South Greene Street
Baltimore, Maryland 21201
343
mi
from 43215
Baltimore, MD
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Baton Rouge, Louisiana 70810
804
mi
from 43215
Baton Rouge, LA
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1305 Airport Freeway
Bedford, Texas 76021
925
mi
from 43215
Bedford, TX
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3400 Uspallata
Buenos Aires, C1437
5387
mi
from 43215
Buenos Aires,
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2010 East 90th Street
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Dayton, Ohio
63
mi
from 43215
Dayton, OH
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2121 East Harmony Road
Fort Collins, Colorado 80528
1158
mi
from 43215
Fort Collins, CO
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16 Chestnut Street
Foxboro, Massachusetts 02035
629
mi
from 43215
Foxboro, MA
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Golden Valley, Minnesota 55422
629
mi
from 43215
Golden Valley, MN
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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...
1958
mi
from 43215
Irvine, CA
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888 West Bonneville Avenue
Las Vegas, Nevada 89106
1757
mi
from 43215
Las Vegas, NV
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Maitland, Florida 32751
788
mi
from 43215
Maitland, FL
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328
mi
from 43215
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...
477
mi
from 43215
New York, NY
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Overland Park, Kansas 66210
624
mi
from 43215
Overland Park, KS
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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...
414
mi
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Philadelphia, PA
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Plainview, New York 11803
505
mi
from 43215
Plainview, NY
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Scarborough, Maine 04074
696
mi
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Scarborough, ME
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503
mi
from 43215
Stamford, CT
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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...
549
mi
from 43215
Stony Brook, NY
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301 Old San Francisco Rd
Sunnyvale, California 94086
2095
mi
from 43215
Sunnyvale, CA
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2013
mi
from 43215
Tacoma, WA
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12912 USF Health Drive
Tampa, Florida 33612
822
mi
from 43215
Tampa, FL
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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...
328
mi
from 43215
Washington,
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110 Cedar Street
Wellesley, Massachusetts 02481
633
mi
from 43215
Wellesley, MA
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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...
312
mi
from 43215
Winston-Salem, NC
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