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
3924 9th Avenue West
Bradenton, Florida 34205
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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...
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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...
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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...
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5090 N 40th St # 250
Phoenix, Arizona 85018
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
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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...
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2020 Peachtree Road
Atlanta, Georgia 30309
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1101 East 33rd Street
Baltimore, Maryland 21287
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Berkeley, CA
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Burlington, VT
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Charlotte, North Carolina
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415 Ray C Hunt Drive
Charlottesville, Virginia 22903
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5841 South Maryland Avenue
Chicago, Illinois 60637
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Columbus, OH
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Edegem, 2650
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Edegem,
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Farmington Hills, Michigan 48334
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2121 East Harmony Road
Fort Collins, Colorado 80528
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Kansas City, Kansas
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Lebanon, NH
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Phoenix, Arizona 85013
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Plainview, New York 11803
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Round Rock, TX
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San Francisco, California 94143
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100 Nicolls Road
Stony Brook, New York 11794
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1225 Northeast 2nd Avenue
Tualatin, Oregon 97062
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Vero Beach, Florida 32960
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Winston-Salem, North Carolina 27103
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