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).

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

220

Study ID:

NCT00676715

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 83 Locations for this study

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Phoenix Neurological Associates Ltd
Phoenix Arizona, 85006, United States
Barrow Neurological Institute
Phoenix Arizona, 85013, United States
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley California, 94705, United States
University of California San Francisco
San Francisco California, 94117, United States
Advanced Neurology of Colorado, LLC
Fort Collins Colorado, 80528, United States
Bradenton Research Center
Bradenton Florida, 34205, United States
MS Center of Vero Beach
Vero Beach Florida, 32960, United States
Shepherd Center; Multiple Sclerosis Center
Atlanta Georgia, 30309, United States
University of Chicago; Neurology
Chicago Illinois, 60637, United States
Kansas University Medical Center
Kansas City Kansas, 66103, United States
John Hopkins University
Baltimore Maryland, 21205, United States
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States
Dartmouth-Hitchcock Medical Center; Dept of Neurology
Lebanon New Hampshire, 03756, United States
Columbia University Medical Center; The Neurological Institute of New York
New York New York, 10032, United States
Island Neurological Associates, P.C.
Plainview New York, 11803, United States
Suny At Stony Brook; Department Of Neurology
Stony Brook New York, 11794, United States
The Neurological Institute PA
Charlotte North Carolina, 28204, United States
Clinical Research of Winston Salem
Winston-Salem North Carolina, 27103, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
Ohio State University Med Ctr; MS Center
Columbus Ohio, 43221, United States
Legacy Health System; Clinical Research & Tech Ctr
Tualatin Oregon, 97062, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37212, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Integra Clinical Research, Llc
San Antonio Texas, 78229, United States
Fletcher Allen Health Care/University of Vermont
Burlington Vermont, 5405, United States
University of Virginia - Fontain Research Park
Charlottesville Virginia, 22903, United States
UZ Antwerpen
Edegem , 2650, Belgium
First MHAT; Clinic of Neurology
Sofia , 1000, Bulgaria
Shat of Cardiovascular Diseases; Clinic of Neurology
Sofia , 1309, Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia , 1407, Bulgaria
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
Sofia , 1527, Bulgaria
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
Sofia , 1606, Bulgaria
Military Medical Academy; Neurology
Sofia , 1606, Bulgaria
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver British Columbia, V6T 2, Canada
St. Michael'S Hospital
Toronto Ontario, M5B 1, Canada
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal Quebec, H3A 2, Canada
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava , 708 5, Czechia
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice , 532 0, Czechia
Fakultni nemocnice Motol; Neurologicka klinika
Praha , 150 0, Czechia
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
Teplice , 415 2, Czechia
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N , 8200, Denmark
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux , 33076, France
CHU De Caen; Service De Neurologie Dejerine
Caen , 14033, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand , 63003, France
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
Nimes , 30029, France
St. Joseph-Krankenhaus
Berlin , 13088, Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin , 13347, Germany
Asklepios Klinik Nord-Heidberg; Neurologie
Hamburg , 22417, Germany
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
Marburg , 35039, Germany
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
Roma Lazio, 00189, Italy
Hospital CIMA, Sta. Engracia
Monterrey Nuevo LEON, 64060, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes , 20127, Mexico
Unidad de Investigacion CIMA SC
Chihuahua , 31200, Mexico
Hospital Cima Chihauhau
Chihuahua , 31328, Mexico
Spitalul Clinic Colentina; Clinica de Neurologie
Bucuresti , 02012, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Targu Mures , 54013, Romania
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva Moskovskaja Oblast, 10715, Russian Federation
Municipal City Hospital #33; Neurology
Nizhny Novgorod Niznij Novgorod, 60307, Russian Federation
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Yekaterinburg Sverdlovsk, 62010, Russian Federation
LLC Research Medical Complex Vashe Zdorovie
Kazan Tatarstan, 44200, Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen Tjumen, 62504, Russian Federation
MRC for Oncology and Neurology; Neurology
Novosibirsk , 63009, Russian Federation
Clinical Center of Serbia; Institute of Neurology
Belgrade , 11000, Serbia
Clinical Center Nis; Clinic for Mental Health
NIS , 18000, Serbia
Clinic of Neurology
Nova Sad , 21000, Serbia
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
Banska Bystrica , 975 1, Slovakia
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
Bratislava , 813 6, Slovakia
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
Kosice , 041 6, Slovakia
Fakultna Nemocnica Nitra; Neurologicka Klinika
Nitra , 949 0, Slovakia
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
Spisska Nova Ves , 05201, Slovakia
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona , 08035, Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona , 08036, Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid , 28034, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla , 41009, Spain
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia , 46026, Spain
Universitätsspital Basel; Neurologie
Basel , 4031, Switzerland
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov , 61068, Ukraine
City Clin.Hosp #4; Dept. of Neurology
Kyiv , 03110, Ukraine
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
Propetrovsk , 49027, Ukraine
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsya , 21005, Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool , L9 7L, United Kingdom
Uni Hospital Queens Medical Centre; Neurology
Nottingham , NG7 2, United Kingdom
Royal Hallamshire Hospital; Neurology
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

220

Study ID:

NCT00676715

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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