A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:3/21/2019
Start Date:July 31, 2008
End Date:December 9, 2021

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Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and
Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as
measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants
with Relapsing Remitting Multiple Sclerosis (RRMS).


Inclusion Criteria:

- Ability to provide written informed consent and to be compliant with the schedule of
protocol assessments

- Relapsing-remitting multiple sclerosis (MS)

- Ages 18-55 years inclusive

- For sexually active female and male participants of reproductive potential, use of
reliable means of contraception

Exclusion Criteria:

- Secondary or primary progressive multiple sclerosis at screening

- Incompatibility with MRI

- Contra-indications to or intolerance of oral or IV corticosteroids

- Known presence of other neurologic disorders

- Pregnancy or lactation

- Lack of peripheral venous access

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

- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic,
endocrine or gastrointestinal

- Congestive heart failure

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

- History or known presence of recurrent or chronic infection

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

- History of alcohol or drug abuse within 24 weeks prior to randomization

- History of or currently active primary or secondary immunodeficiency

- History of coagulation disorders

- Treatment with any investigational agent within 4 weeks of screening

- Receipt of a live vaccine within 6 weeks prior to randomization

- Incompatibility with Avonex use

- Previous treatment with rituximab

- Previous treatment with lymphocyte-depleting therapies except mitoxantrone

- Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization

- Treatment with beta interferons, glatiramer acetate, IV immunoglobulin,
plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization

- Systemic corticosteroid therapy within 4 weeks prior to randomization
We found this trial at
29
sites
2121 East Harmony Road
Fort Collins, Colorado 80528
839
mi
from 91732
Fort Collins, CO
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3924 9th Avenue West
Bradenton, Florida 34205
2139
mi
from 91732
Bradenton, FL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
mi
from 91732
Cleveland, OH
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1357
mi
from 91732
Houston, TX
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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...
1762
mi
from 91732
Nashville, TN
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5090 N 40th St # 250
Phoenix, Arizona 85018
347
mi
from 91732
Phoenix, AZ
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
1181
mi
from 91732
San Antonio, TX
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
648
mi
from 91732
Albuquerque, NM
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2020 Peachtree Road
Atlanta, Georgia 30309
1918
mi
from 91732
Atlanta, GA
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1101 East 33rd Street
Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
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354
mi
from 91732
Berkeley, CA
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2467
mi
from 91732
Burlington, VT
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Charlotte, North Carolina
2102
mi
from 91732
Charlotte, NC
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415 Ray C Hunt Drive
Charlottesville, Virginia 22903
2206
mi
from 91732
Charlottesville, VA
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5841 South Maryland Avenue
Chicago, Illinois 60637
1730
mi
from 91732
Chicago, IL
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1960
mi
from 91732
Columbus, OH
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Edegem, 2650
5590
mi
from 91732
Edegem,
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Farmington Hills, Michigan 48334
1952
mi
from 91732
Farmington Hills, MI
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Kansas City, Kansas
1339
mi
from 91732
Kansas City, KS
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2515
mi
from 91732
Lebanon, NH
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2435
mi
from 91732
New York, NY
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Phoenix, Arizona 85013
342
mi
from 91732
Phoenix, AZ
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Plainview, New York 11803
2460
mi
from 91732
Plainview, NY
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1208
mi
from 91732
Round Rock, TX
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San Francisco, California 94143
356
mi
from 91732
San Francisco, CA
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100 Nicolls Road
Stony Brook, New York 11794
2477
mi
from 91732
Stony Brook, NY
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1225 Northeast 2nd Avenue
Tualatin, Oregon 97062
828
mi
from 91732
Tualatin, OR
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Vero Beach, Florida 32960
2261
mi
from 91732
Vero Beach, FL
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Winston-Salem, North Carolina 27103
2123
mi
from 91732
Winston-Salem, NC
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