A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:3/21/2019
Start Date:February 11, 2016
End Date:December 30, 2019

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An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who
have had a suboptimal response to an adequate course of DMT. Participants will receive
ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg
total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up
to 96 weeks). Anticipated time on study treatment is 96 weeks.


Inclusion Criteria:

- Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised
2010 McDonald criteria

- Disease duration from first symptom of less than or equal to (
- Treated with an adequate course of treatment with no more than three prior DMT
regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the
most recent adequately used DMT was due to suboptimal response

- Suboptimal response while the participant was on his/her last adequately used DMT for
>/=6 months (defined by having one of the following qualifying events despite being on
a stable dose of the same DMT for at least 6 months: one or more clinically reported
relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2
lesions on MRI); these qualifying events must have occurred while on the last
adequately used DMT. In participants receiving stable doses of the same approved DMT
for more than a year, the event must have occurred within the last 12 months of
treatment with this DMT from the date of screening

Exclusion Criteria:

- History of primary progressive multiple sclerosis (PPMS), progressive relapsing
multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)

- Contraindications for MRI

- Known presence of other neurological disorders that may mimic multiple sclerosis

- Pregnancy or lactation, or intention to become pregnant during the study

- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study

- History of 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

- Active infection, or history of or known presence of recurrent or chronic infection
such as human immunodeficiency virus (HIV), syphilis, or tuberculosis

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or IV corticosteroids

- Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in
participants whose lymphocyte count is below the lower limit of normal (LLN)

- Treatment with alemtuzumab (Lemtrada®)

- Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate
mofetil, cyclosporine, or methotrexate

- Previous treatment with natalizumab within 12 months prior to screening unless failure
was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously
treated with natalizumab will be eligible for this study only if duration of treatment
with natalizumab was less than (<) 1 year and natalizumab was not used in the 12
months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive
or negative) and titer (both assessed within the year of screening) must be documented
prior to enrollment

- Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to
screening

- Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept,
belimumab, or ofatumumab)

- Treatment with a drug that is experimental (Exception: treatment with an experimental
drug that was subsequently approved in the participant's country is allowed)
We found this trial at
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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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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5090 N 40th St # 250
Phoenix, Arizona 85018
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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Atlanta, Georgia 30327
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1115 Ronald Reagan Parkway
Avon, Indiana 46123
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22 South Greene Street
Baltimore, Maryland 21201
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Baltimore, Maryland 21287
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330 Brookline Avenue
Boston, Massachusetts 02215
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1403 29 Street Northwest
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Carlsbad, California 92011
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6555 Coyle Avenue
Carmichael, California 95608
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Centennial, Colorado 80112
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Chicago, Illinois 60637
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2010 East 90th Street
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Fairfield, Connecticut 06824
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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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Freehold, New Jersey 07728
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Golden Valley, Minnesota 55422
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7000 Fannin Street
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Indianapolis, Indiana 46256
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
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Knoxville, Tennessee 37916
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La Jolla, California 92037
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888 West Bonneville Avenue
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16 Hayden Avenue
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Lubbock, Texas 79410
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1600 Northwest 10th Avenue
Miami, Florida 33136
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259 1st St
Mineola, New York 11501
(516) 663-0333
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New Orleans, Louisiana 70121
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630 W 168th St
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165 Wadsworth Drive
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101 Nicolls Rd
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(631) 444-4000
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12912 USF Health Drive
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