A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00676715
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2008-07-17
2023-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Placebo
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Ocrelizumab 600 mg
Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Ocrelizumab
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Ocrelizumab 1000 mg
Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Ocrelizumab
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Avonex
Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Avonex
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Interventions
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Placebo
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Ocrelizumab
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Avonex
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States
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
University of Virginia - Fontain Research Park
Charlottesville, Virginia, United States
UZ Antwerpen
Edegem, , Belgium
First MHAT; Clinic of Neurology
Sofia, , Bulgaria
Shat of Cardiovascular Diseases; Clinic of Neurology
Sofia, , Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia, , Bulgaria
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
Sofia, , Bulgaria
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
Sofia, , Bulgaria
Military Medical Academy; Neurology
Sofia, , Bulgaria
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver, British Columbia, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava, , Czechia
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice, , Czechia
Fakultni nemocnice Motol; Neurologicka klinika
Prague, , Czechia
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
Teplice, , Czechia
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N, , Denmark
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, , France
CHU De Caen; Service De Neurologie Dejerine
Caen, , France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, , France
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
Nîmes, , France
St. Joseph-Krankenhaus
Berlin, , Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, , Germany
Asklepios Klinik Nord-Heidberg; Neurologie
Hamburg, , Germany
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
Marburg, , Germany
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
Rome, Lazio, Italy
Hospital CIMA, Sta. Engracia
Monterrey, Nuevo León, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, , Mexico
Unidad de Investigacion CIMA SC
Chihuahua City, , Mexico
Hospital Cima Chihauhau
Chihuahua City, , Mexico
Spitalul Clinic Colentina; Clinica de Neurologie
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Târgu Mureş, , Romania
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva, Moscow Oblast, Russia
Municipal City Hospital #33; Neurology
Nizhny Novgorod, Niznij Novgorod, Russia
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Yekaterinburg, Sverdlovsk Oblast, Russia
LLC Research Medical Complex Vashe Zdorovie
Kazan', Tatarstan Republic, Russia
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen, Tyumen Oblast, Russia
MRC for Oncology and Neurology; Neurology
Novosibirsk, , Russia
Clinical Center of Serbia; Institute of Neurology
Belgrade, , Serbia
Clinical Center Nis; Clinic for Mental Health
Niš, , Serbia
Clinic of Neurology
Nova Sad, , Serbia
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
Banská Bystrica, , Slovakia
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
Bratislava, , Slovakia
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
Košice, , Slovakia
Fakultna Nemocnica Nitra; Neurologicka Klinika
Nitra, , Slovakia
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
Spišská Nová Ves, , Slovakia
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona, , Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Málaga, , Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, , Spain
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia, , Spain
Universitätsspital Basel; Neurologie
Basel, , Switzerland
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkiv, , Ukraine
City Clin.Hosp #4; Dept. of Neurology
Kyiv, , Ukraine
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
Propetrovsk, , Ukraine
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsia, , Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool, , United Kingdom
Uni Hospital Queens Medical Centre; Neurology
Nottingham, , United Kingdom
Royal Hallamshire Hospital; Neurology
Sheffield, , United Kingdom
Countries
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References
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Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.
Other Identifiers
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2007-006338-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA21493
Identifier Type: OTHER
Identifier Source: secondary_id
ACT4422g
Identifier Type: -
Identifier Source: org_study_id