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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676715
First Posted: May 13, 2008
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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).

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Placebo Drug: Ocrelizumab Drug: Avonex Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain [ Time Frame: Week 12 to Week 24 ]
    Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.


Secondary Outcome Measures:
  • Annualized Protocol Defined Relapse Rate at Week 24 [ Time Frame: Week 24 ]
    Adjusted annualized relapse rate for geographical region.

  • Percentage of Participants Who Remained Relapse Free at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants who remained relapse free at week 24 were reported.

  • Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24 [ Time Frame: Baseline, Week 24 ]
    Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.

  • Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain [ Time Frame: Weeks 4 to Week 24 ]
    Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.

  • Total Number of Gadolinium-Enhancing T1 Lesions at Weeks [ Time Frame: Weeks 4 to Week 24 ]
    Total number of gadolinium-enhancing T1 lesions at weeks were reported.


Enrollment: 220
Actual Study Start Date: July 31, 2008
Estimated Study Completion Date: November 7, 2018
Primary Completion Date: March 9, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: Placebo
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Drug: Ocrelizumab
Two infusion 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.
Other Name: RO4964913
Experimental: 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.
Drug: 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.
Other Name: RO4964913
Experimental: 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.
Drug: Ocrelizumab
Ocrelizumab 1000 mg IV infusions was administered on cycle 1 Day 1.
Other Name: RO4964913
Active Comparator: 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.
Drug: Ocrelizumab
Two infusion 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.
Other Name: RO4964913
Drug: Avonex
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Other Name: Interferon-beta-alpha1

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676715


  Hide Study Locations
Locations
United States, Arizona
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley, California, United States, 94705
University of California S Francisco Multiple Sclerosis Ctr
San Francisco, California, United States, 94117
United States, Colorado
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States, 80528
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
MS Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Georgia
Shepherd Center; Multiple Sclerosis Center
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago; Neurology
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66103
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21205
United States, Michigan
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States, 48334
United States, New Hampshire
Dartmouth-Hitchcock Medical Center; Dept of Neurology
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Columbia University Medical Center; The Neurological Institute of New York
New York, New York, United States, 10032
Island Neurological Associates, P.C.
Plainview, New York, United States, 11803
Suny At Stony Brook; Department Of Neurology
Stony Brook, New York, United States, 11794
United States, North Carolina
The Neurological Institute PA
Charlotte, North Carolina, United States, 28204
Clinical Research of Winston Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University Med Ctr; MS Center
Columbus, Ohio, United States, 43221
United States, Oregon
Legacy Health System; Clinical Research & Tech Ctr
Tualatin, Oregon, United States, 97062
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Integra Clinical Research, Llc
San Antonio, Texas, United States, 78229
United States, Vermont
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia - Fontain Research Park
Charlottesville, Virginia, United States, 22903
Belgium
UZ Antwerpen
Edegem, Belgium, 2650
AZ Alma vzw (Sijsele)
Sijsele, Belgium, 8340
Bulgaria
Shat Np Sveti Naum; 3Rd Clinic of Neurology
Sofia, Bulgaria, 1113
First MHAT; Clinic of Neurology
Sofia, Bulgaria, 1142
Shat of Cardiovascular Diseases; Clinic of Neurology
Sofia, Bulgaria, 1309
Tokuda Hospital; Department of Neurology
Sofia, Bulgaria, 1407
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
Sofia, Bulgaria, 1527
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
Sofia, Bulgaria, 1606
Military Medical Academy; Neurology
Sofia, Bulgaria, 1606
Canada, British Columbia
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
St. Michael'S Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada, H3A 2B4
Czechia
Fakultni Nemocnice Ostrava; Neurologicka Klinika
Ostrava, Czechia, 708 52
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice, Czechia, 532 03
VFN Praha Poliklinika Rs Centrum - Budova A
Prague, Czechia, 12808
Fakultni nemocnice Motol; Neurologicka klinika
Praha, Czechia, 150 06
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
Teplice, Czechia, 415 29
Denmark
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
Aarhus C, Denmark, 8000
Finland
Helsinki University Central Hospital; Department of Neurology
Helsinki, Finland, 00290
Suomen Terveystalo Clinical Research Oy
Turku, Finland, 20100
France
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, France, 33076
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
Bron, France, 69677
CHU De Caen; Service De Neurologie Dejerine
Caen, France, 14033
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, France, 63003
Hôpital Gui de Chauliac - CHU de Montpellier; Service des explorations neurologiques
Montpellier, France, 34295
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
Nimes, France, 30029
Germany
St. Joseph-Krankenhaus
Berlin, Germany, 13088
Judisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, Germany, 13347
Asklepios Klinik St. Georg; Neurologische Klinik
Hamburg, Germany, 20099
Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt
Hamburg, Germany, 22083
Asklepiosklinik Barmbek; Abteilung Neurologie
Hamburg, Germany, 22291
Asklepios Klinik Nord-Heidberg; Neurologie
Hamburg, Germany, 22417
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
Marburg, Germany, 35039
Villa Sauer, Praxis für; Neurologie und Psychiatrie
Siegen, Germany, 57072
Italy
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
Roma, Lazio, Italy, 00189
Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
Milano, Lombardia, Italy, 20132
Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, Mexico, 20127
Unidad de Investigacion en Salud
Chihuahua, Mexico, 31205
Hospital Cima Chihauhau
Chihuahua, Mexico, 31328
Hospital CIMA, Sta. Engracia
Monterrey, Nuevo León, Mexico, 64060
Netherlands
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Romania
Spitalul Clinic Colentina; Clinica de Neurologie
Bucuresti, Romania, 020125
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Targu Mures, Romania, 540136
Russian Federation
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Ekaterinburg, Russian Federation, 620102
LLC Research Medical Complex Vashe Zdorovie
Kazan, Russian Federation, 4420029
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moscow, Russian Federation, 107150
Municipal City Hospital #33; Neurology
Nizhny Novgorod, Russian Federation, 603076
MRC for Oncology and Neurology; Neurology
Novosibirsk, Russian Federation, 630090
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen, Russian Federation, 625000
Serbia
Clinical Center of Serbia; Institute of Neurology
Belgrade, Serbia, 11000
Clinical Center Nis; Clinic for Mental Health
NIS, Serbia, 18000
Clinic of Neurology
Nova sad, Serbia, 21000
Slovakia
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
Banska Bystrica, Slovakia, 975 17
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
Bratislava, Slovakia, 813 69
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
Kosice, Slovakia, 041 66
Fakultna Nemocnica Nitra; Neurologicka Klinika
Nitra, Slovakia, 949 01
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
Spisska Nova Ves, Slovakia, 05201
Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona, Spain, 08035
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, Spain, 08036
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, Spain, 28034
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla, Spain, 41009
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia, Spain, 46026
Switzerland
Universitätsspital Basel; Neurologie
Basel, Switzerland, 4031
Ukraine
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov, Ukraine, 61068
City Clin.Hosp #4; Dept. of Neurology
Kyiv, Ukraine, 03110
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
Propetrovsk, Ukraine, 49027
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsya, Ukraine, 21005
United Kingdom
Walton Center For Neurology & Neurosurgery; Clinical Trials Unit
Liverpool, United Kingdom, L9 7LJ
Royal Victoria Infirmary; Neurology Dept.
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Uni Hospital Queens Medical Centre; Neurology
Nottingham, United Kingdom, NG7 2UH
Royal Hallamshire Hospital; Neurology
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00676715     History of Changes
Other Study ID Numbers: ACT4422g
2007-006338-32 ( EudraCT Number )
WA21493 ( Other Identifier: Hoffmann-La Roche )
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic