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
Berkeley, California 94705
352
mi
from 91732
Berkeley, CA
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3924 9th Avenue West
Bradenton, Florida 34205
2139
mi
from 91732
Bradenton, FL
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5090 N 40th St # 250
Phoenix, Arizona 85018
347
mi
from 91732
Phoenix, AZ
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
2134
mi
from 91732
Tampa, FL
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152 East Kinderton Way
Advance, North Carolina 27006
2117
mi
from 91732
Advance, NC
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47 New Scotland Avenue
Albany, New York 12208
2439
mi
from 91732
Albany, NY
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Albuquerque, New Mexico 87131
651
mi
from 91732
Albuquerque, NM
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Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
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Atlanta, Georgia 30327
1919
mi
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Atlanta, GA
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825
mi
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Aurora, CO
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2001 Vail Avenue
Charlotte, North Carolina 28207
2103
mi
from 91732
Charlotte, NC
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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,...
1730
mi
from 91732
Chicago, IL
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1957
mi
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Columbus, OH
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Cordova, Tennessee 38018
1601
mi
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Cordova, TN
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Dallas, Texas 75390
1221
mi
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Dallas, TX
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1966
mi
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Detroit, MI
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2799 West Grand Boulevard
Detroit, Michigan 48202
1965
mi
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Detroit, MI
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Farmington Hills, Michigan 48334
1952
mi
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Farmington Hills, MI
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Golden Valley, Minnesota 55422
1507
mi
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Golden Valley, MN
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Hobart, Tasmania
7980
mi
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Hobart,
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7200 Cambridge Street
Houston, Texas 77030
1357
mi
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Houston, TX
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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...
1332
mi
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Kansas City, KS
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301 North Maitland Avenue
Maitland, Florida 32751
2182
mi
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Maitland, FL
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2322
mi
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Miami, FL
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2900 West Oklahoma Avenue
Milwaukee, Wisconsin 53215
1726
mi
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Milwaukee, WI
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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,...
2451
mi
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Mineola, NY
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720 Southeast Washington Avenue
Minneapolis, Minnesota 55414
1511
mi
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Minneapolis, MN
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2351
mi
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New York, NY
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10 Union Square East
New York, New York 10029
2433
mi
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New York, NY
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3900 West Coast Highway
Newport Beach, California 92663
31
mi
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Newport Beach, CA
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825 Northeast 13th Street
Oklahoma City, Oklahoma 73104
1166
mi
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Oklahoma City, OK
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77 Medford Avenue
Patchogue, New York 11772
2484
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Patchogue, NY
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
2373
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Philadelphia, PA
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Phoenix, Arizona 85013
342
mi
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Phoenix, AZ
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Phoenix, Arizona 85050
346
mi
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Phoenix, AZ
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10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
1339
mi
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Prairie Village, KS
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Providence, Rhode Island 02905
2562
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Providence, RI
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Raleigh, North Carolina 27607
2214
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Raleigh, NC
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Richmond, Virginia 23226
2263
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Richmond, VA
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2248
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Rochester, NY
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1208
mi
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Round Rock, TX
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4860 Y Street
Sacramento, California 95817
363
mi
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Sacramento, CA
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1 Childrens Place
Saint Louis, Missouri 63110
1569
mi
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Saint Louis, MO
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505 Parnassus Avenue
San Francisco, California 94143
356
mi
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San Francisco, CA
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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...
356
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Scottsdale, AZ
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961
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Seattle, WA
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Stony Brook, New York 11794
2478
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Stony Brook, NY
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Teaneck, New Jersey 07666
2431
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Teaneck, NJ
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1225 Northeast 2nd Avenue
Tualatin, Oregon 97062
828
mi
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Tualatin, OR
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Vero Beach, Florida 32960
2261
mi
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Vero Beach, FL
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