Multiple Sclerosis Clinical Trial
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Summary
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).
Eligibility Criteria
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
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There are 83 Locations for this study
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85013, United States
Berkeley California, 94705, United States
San Francisco California, 94117, United States
Fort Collins Colorado, 80528, United States
Bradenton Florida, 34205, United States
Vero Beach Florida, 32960, United States
Atlanta Georgia, 30309, United States
Chicago Illinois, 60637, United States
Kansas City Kansas, 66103, United States
Baltimore Maryland, 21205, United States
Farmington Hills Michigan, 48334, United States
Lebanon New Hampshire, 03756, United States
New York New York, 10032, United States
Plainview New York, 11803, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43221, United States
Tualatin Oregon, 97062, United States
Nashville Tennessee, 37212, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Burlington Vermont, 5405, United States
Charlottesville Virginia, 22903, United States
Edegem , 2650, Belgium
Sofia , 1000, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1606, Bulgaria
Vancouver British Columbia, V6T 2, Canada
Toronto Ontario, M5B 1, Canada
Montreal Quebec, H3A 2, Canada
Ostrava , 708 5, Czechia
Pardubice , 532 0, Czechia
Praha , 150 0, Czechia
Teplice , 415 2, Czechia
Aarhus N , 8200, Denmark
Bordeaux , 33076, France
Caen , 14033, France
Clermont-Ferrand , 63003, France
Nimes , 30029, France
Berlin , 13088, Germany
Berlin , 13347, Germany
Hamburg , 22417, Germany
Marburg , 35039, Germany
Roma Lazio, 00189, Italy
Monterrey Nuevo LEON, 64060, Mexico
Aguascalientes , 20127, Mexico
Chihuahua , 31200, Mexico
Chihuahua , 31328, Mexico
Bucuresti , 02012, Romania
Targu Mures , 54013, Romania
Moskva Moskovskaja Oblast, 10715, Russian Federation
Nizhny Novgorod Niznij Novgorod, 60307, Russian Federation
Ekaterinburg Sverdlovsk, 62010, Russian Federation
Kazan Tatarstan, 44200, Russian Federation
Tyumen Tjumen, 62504, Russian Federation
Novosibirsk , 63009, Russian Federation
Belgrade , 11000, Serbia
NIS , 18000, Serbia
Nova Sad , 21000, Serbia
Banska Bystrica , 975 1, Slovakia
Bratislava , 813 6, Slovakia
Kosice , 041 6, Slovakia
Nitra , 949 0, Slovakia
Spisska Nova Ves , 05201, Slovakia
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
Basel , 4031, Switzerland
Kharkov , 61068, Ukraine
Kyiv , 03110, Ukraine
Propetrovsk , 49027, Ukraine
Vinnytsya , 21005, Ukraine
Liverpool , L9 7L, United Kingdom
Nottingham , NG7 2, United Kingdom
Sheffield , S10 2, United Kingdom
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