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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:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00676715
First received: May 9, 2008
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluat e the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens o f ocrelizumab in patients with RRMS.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: interferon beta-1a
Drug: methylprednisolone
Drug: ocrelizumab
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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: Weeks 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annualized protocol defined relapse rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients who remain relapse-free [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in total volume of T2 lesions on MRI scans of the brain [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: January 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methylprednisolone
IV repeating dose
Drug: ocrelizumab
IV repeating dose
Experimental: 2 Drug: methylprednisolone
IV repeating dose
Drug: ocrelizumab
IV repeating dose
Placebo Comparator: 3 Drug: methylprednisolone
IV repeating dose
Drug: placebo
Intravenous repeating dose
Active Comparator: 4 Drug: interferon beta-1a
Intramuscular repeating dose
Drug: methylprednisolone
IV repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 MS
  • Ages 18-55 years inclusive
  • For sexually active female and male patients 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 i.v. 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 i.v. 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, i.v. immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to randomization
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676715

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85013
United States, California
Berkeley, California, United States, 94705
San Francisco, California, United States, 94117
United States, Colorado
Fort Collins, Colorado, United States, 80528
United States, Florida
Bradenton, Florida, United States, 34205
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Michigan
Farmington Hills, Michigan, United States, 48334
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York, New York, United States, 10032
Plainview, New York, United States, 11803
Stony Brook, New York, United States, 11794
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
United States, Oregon
Tualatin, Oregon, United States, 97062
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Texas
Houston, Texas, United States, 77030
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78229
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Charlottesville, Virginia, United States, 22903
Belgium
Edegem, Belgium, 2650
Sijsele-Damme, Belgium, 8340
Bulgaria
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1113
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1142
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1527
Canada, British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H3A 2B4
Czech Republic
Ostrava, Czech Republic, 708 52
Pardubice, Czech Republic, 532 03
Prague, Czech Republic, 12808
Praha, Czech Republic, 150 06
Teplice, Czech Republic, 415 29
Denmark
Arhus, Denmark, 8000
Finland
Helsinki, Finland, 00290
Turku, Finland, 20100
France
Bordeaux, France, 33076
Bron, France, 69677
Caen, France, 14033
Clermont-Ferrand, France, 63003
Montpellier, France, 34295
Nimes, France, 30029
Germany
Berlin, Germany, 13347
Berlin, Germany, 13088
Hamburg, Germany, 20099
Hamburg, Germany, 22417
Hamburg, Germany, 22083
Hamburg, Germany, 22291
Marburg, Germany, 35039
Regensburg, Germany, 93053
Siegen, Germany, 57072
Tübingen, Germany, 72076
Ulm, Germany, 89081
Italy
Roma, Lazio, Italy, 00189
Milano, Lombardia, Italy, 20132
Mexico
Aguascalientes, Mexico, 20127
Chihuahua, Mexico, 31205
Chihuahua, Mexico, 31328
Monterrey, Nuevo León, Mexico, 64060
Netherlands
Breda, Netherlands, 4818 CK
Romania
Bucuresti, Romania, 020125
Targu Mures, Romania, 540136
Russian Federation
Ekaterinburg, Russian Federation, 620102
Kazan, Russian Federation, 4420029
Mosow, Russian Federation, 129128
Nizhny Novgorod, Russian Federation, 603076
Novosibirsk, Russian Federation, 630090
Tyumen, Russian Federation, 625000
Serbia
Belgrade, Serbia, 11000
NIS, Serbia, 18000
Nova sad, Serbia, 21000
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 813 69
Kosice, Slovakia, 041 66
Nitra, Slovakia, 949 01
Spisska Nova Ves, Slovakia, 05201
Spain
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Madrid, Spain, 28034
Malaga, Spain, 29010
Sevilla, Spain, 41009
Valencia, Spain, 46009
Switzerland
Basel, Switzerland, 4031
Ukraine
Kharkov, Ukraine, 61068
Kyiv, Ukraine, 03110
Propetrovsk, Ukraine, 49027
Vinnytsya, Ukraine, 21005
United Kingdom
Liverpool, United Kingdom, L9 7LJ
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Nottingham, United Kingdom, NG7 2UH
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional 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, WA21493
Study First Received: May 9, 2008
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Adjuvants, Immunologic
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 24, 2014