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

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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).

Key facts

Study ID

NCT00676715

Run by

Genentech, Inc.

People needed

220

Starts

2008-07-17

Expected to finish

2023-11-08

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• East Bay Physicians Med Group;Sutter East Bay Med Foundation — Berkeley, California, United States
• University of California San Francisco — San Francisco, California, United States
• Advanced Neurology of Colorado, LLC — Fort Collins, Colorado, United States
• Bradenton Research Center — Bradenton, Florida, United States
• MS Center of Vero Beach — Vero Beach, Florida, United States
• Shepherd Center; Multiple Sclerosis Center — Atlanta, Georgia, United States
• University of Chicago; Neurology — Chicago, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• John Hopkins University — Baltimore, Maryland, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• Dartmouth-Hitchcock Medical Center; Dept of Neurology — Lebanon, New Hampshire, United States
• Columbia University Medical Center; The Neurological Institute of New York — New York, New York, United States
• Island Neurological Associates, P.C. — Plainview, New York, United States
• Suny At Stony Brook; Department Of Neurology — Stony Brook, New York, United States
• The Neurological Institute PA — Charlotte, North Carolina, United States
• Clinical Research of Winston Salem — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University Med Ctr; MS Center — Columbus, Ohio, United States
• Legacy Health System; Clinical Research & Tech Ctr — Tualatin, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Integra Clinical Research, Llc — San Antonio, Texas, United States
• Fletcher Allen Health Care/University of Vermont — Burlington, Vermont, United States
• Phoenix Neurological Associates Ltd — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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