A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:3/8/2019
Start Date:March 2, 2011
End Date:December 9, 2021

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A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

This randomized, parallel group, double-blind, placebo controlled study will evaluate the
efficacy and safety of ocrelizumab in participants with primary progressive multiple
sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or
placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label
Extension (OLE) treatment for participants in both groups who in the opinion of the
investigator could benefit from further or newly initiated ocrelizumab treatment. Unless
terminated early, all participants may continue their treatment with open-label ocrelizumab
until 31 December 2020.


Inclusion Criteria:

- Diagnosis of primary progressive multiple sclerosis (according to revised McDonald
criteria)

- EDSS at screening from 3 to 6.5 points

- Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than
(>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0

- Sexually active male and female participants of reproductive potential must use two
methods of contraception throughout the study treatment phase and for 48 weeks after
the last dose

Exclusion Criteria:

- History of relapsing remitting MS, secondary progressive, or progressive relapsing MS
at screening

- Inability to complete an MRI (contraindications for MRI)

- Known presence of other neurologic disorders

- Known active infection or history of or presence of recurrent or chronic infection

- History of cancer, including solid tumors and hematological malignancies (except for
basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the
cervix that have been excised and resolved)

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

- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab,
anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone,
azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body
irradiation, or bone marrow transplantation

- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study
We found this trial at
50
sites
3924 9th Avenue West
Bradenton, Florida 34205
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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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152 East Kinderton Way
Advance, North Carolina 27006
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Advance, NC
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47 New Scotland Avenue
Albany, New York 12208
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Albuquerque, New Mexico 87131
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Atlanta, Georgia 30322
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Atlanta, Georgia 30327
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Aurora, CO
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Berkeley, California 94705
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2001 Vail Avenue
Charlotte, North Carolina 28207
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Columbus, OH
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Cordova, Tennessee 38018
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Dallas, Texas 75390
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2799 West Grand Boulevard
Detroit, Michigan 48202
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Farmington Hills, Michigan 48334
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Golden Valley, Minnesota 55422
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Hobart, Tasmania
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7200 Cambridge Street
Houston, Texas 77030
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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301 North Maitland Avenue
Maitland, Florida 32751
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2900 West Oklahoma Avenue
Milwaukee, Wisconsin 53215
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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720 Southeast Washington Avenue
Minneapolis, Minnesota 55414
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10 Union Square East
New York, New York 10029
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3900 West Coast Highway
Newport Beach, California 92663
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825 Northeast 13th Street
Oklahoma City, Oklahoma 73104
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77 Medford Avenue
Patchogue, New York 11772
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85013
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Phoenix, Arizona 85050
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10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
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Providence, Rhode Island 02905
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Raleigh, North Carolina 27607
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Richmond, Virginia 23226
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Rochester, NY
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Round Rock, TX
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4860 Y Street
Sacramento, California 95817
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1 Childrens Place
Saint Louis, Missouri 63110
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505 Parnassus Avenue
San Francisco, California 94143
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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Stony Brook, New York 11794
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Teaneck, New Jersey 07666
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1225 Northeast 2nd Avenue
Tualatin, Oregon 97062
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Vero Beach, Florida 32960
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