A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
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
Sites / Locations
- Phoenix Neurological Associates Ltd
- Barrow Neurological Institute
- East Bay Physicians Med Group;Sutter East Bay Med Foundation
- University of California San Francisco
- Advanced Neurology of Colorado, LLC
- Bradenton Research Center
- MS Center of Vero Beach
- Shepherd Center; Multiple Sclerosis Center
- University of Chicago; Neurology
- Kansas University Medical Center
- John Hopkins University
- Michigan Institute for Neurological Disorders
- Dartmouth-Hitchcock Medical Center; Dept of Neurology
- Columbia University Medical Center; The Neurological Institute of New York
- Island Neurological Associates, P.C.
- Suny At Stony Brook; Department Of Neurology
- The Neurological Institute PA
- Clinical Research of Winston Salem
- Cleveland Clinic
- Ohio State University Med Ctr; MS Center
- Legacy Health System; Clinical Research & Tech Ctr
- Vanderbilt University Medical Center
- Baylor College of Medicine
- Integra Clinical Research, Llc
- Fletcher Allen Health Care/University of Vermont
- University of Virginia - Fontain Research Park
- UZ Antwerpen
- First MHAT; Clinic of Neurology
- Shat of Cardiovascular Diseases; Clinic of Neurology
- ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
- UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
- CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
- Military Medical Academy; Neurology
- Uni of British Columbia Hospital; Ms Clinical Research Group
- St. Michael'S Hospital
- McGill University; Montreal Neurological Institute; Neurological and Psychiatric
- Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
- Krajska Nemocnice Pardubice Neurologicka Klinika
- Fakultni nemocnice Motol; Neurologicka klinika
- Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
- Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
- Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
- CHU De Caen; Service De Neurologie Dejerine
- Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
- CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
- St. Joseph-Krankenhaus
- Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
- Asklepios Klinik Nord-Heidberg; Neurologie
- Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
- Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
- Hospital CIMA, Sta. Engracia
- Instituto Biomedico De Investigacion A.C.
- Unidad de Investigacion CIMA SC
- Hospital Cima Chihauhau
- Spitalul Clinic Colentina; Clinica de Neurologie
- Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
- Central Clinical Hospital #2 N.A. Semashko OAO RJHD
- Municipal City Hospital #33; Neurology
- SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
- LLC Research Medical Complex Vashe Zdorovie
- Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
- MRC for Oncology and Neurology; Neurology
- Clinical Center of Serbia; Institute of Neurology
- Clinical Center Nis; Clinic for Mental Health
- Clinic of Neurology
- Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
- Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
- Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
- Fakultna Nemocnica Nitra; Neurologicka Klinika
- Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
- Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
- Hospital Clinic i Provincial; Servicio de Neurologia
- Hospital Ramon y Cajal; Servicio de Neurologia
- Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
- Hospital Universitario Virgen Macarena; Servicio de Neurologia
- Hospital Universitario La Fe; Unidad de Esclerosis Multiple
- Universitätsspital Basel; Neurologie
- Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
- City Clin.Hosp #4; Dept. of Neurology
- Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
- Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
- Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
- Uni Hospital Queens Medical Centre; Neurology
- Royal Hallamshire Hospital; Neurology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Active Comparator
Placebo
Ocrelizumab 600 mg
Ocrelizumab 1000 mg
Avonex
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.
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.
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.
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.