Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
NCT ID: NCT00078338
Last Updated: 2018-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
764 participants
INTERVENTIONAL
2004-02-16
2006-11-28
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
NONE
Study Groups
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Rebif®
Rebif®
Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
Copaxone®
Copaxone®
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Interventions
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Rebif®
Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
Copaxone®
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have definite relapsing multiple sclerosis
* Have had one or more relapses within the prior 12 months
* Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
* Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive
* If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding
* Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized
* Be willing and able to comply with the protocol for the duration of the study
* Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Exclusion Criteria
* Prior use of any interferon or glatiramer acetate
* Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI)
* Have a psychiatric disorder that is unstable or would preclude safe participation in the study.
* Have significant leukopenia (white blood cell count \< 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1.
* Have elevated liver function tests (alanine aminotransferase \[AST\], aspartate aminotransferase \[ALT\], alkaline phosphatase \> 2.0 times the upper limit of normal \[ULN\] of the central laboratory, or total bilirubin \> 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced)
* Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
* Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1
* Prior use of cladribine or have received total lymphoid irradiation
* Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid
* Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1.
* Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus \[HIV\], human T-cell lymphotrophic virus type I \[HTLV-1\])
* Have had plasma exchange in 3 months prior to Study Day 1.
18 Years
60 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurology Clinics
Phoenix, Arizona, United States
Northwest NeuroSpecialists
Tucson, Arizona, United States
University of California, Davis
Sacramento, California, United States
Kaiser Permanente Neurology
San Diego, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
The MS Treatment Center at Griffin Hospital
Derby, Connecticut, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
Neurological Center of South Florida
Miami, Florida, United States
Harbourside Medical Plaza
Tampa, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
University Chicago Hospitals
Chicago, Illinois, United States
Consultants In Neurology, Ltd.
Northbrook, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
University of Maryland MD Center for MS
Baltimore, Maryland, United States
University Of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Hospital Dept of Neurology
Detroit, Michigan, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
University of Minnesota Medical School, Dept of Neurology
Minneapolis, Minnesota, United States
Nevada Neurological Consultants
Henderson, Nevada, United States
Albany Medical College Dept of Neurology MC-70
Albany, New York, United States
Neurology University of Rochester
Rochester, New York, United States
SUNY At Stony Brook U Hospital - Department of Neurology
Stony Brook, New York, United States
SUNY Upstate Medical University Dept of Neurology
Syracuse, New York, United States
MS Center/CHS
Charlotte, North Carolina, United States
Wake Forest Univ. Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
Medford Neurological and Spine Clinic
Medford, Oregon, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Physicians Dept of Neurology
Philadelphia, Pennsylvania, United States
Baptist West Hospital
Knoxville, Tennessee, United States
University of Texas-Houston
Houston, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
Neurology Health Care Service / Fletcher Allen Health Care
Burlington, Vermont, United States
Neurology Center of Fairfax
Fairfax, Virginia, United States
Blue Ridge Research Center
Roanoke, Virginia, United States
Minor & James Medical, PLLC
Seattle, Washington, United States
CAMC Institute
Charleston, West Virginia, United States
Center for Neurological Disorders
Milwaukee, Wisconsin, United States
Servicio de Neurologia
Buenos Aires, , Argentina
Departmento Enfermedades Desmielinizantes
Buenos Aires, , Argentina
Servicio de Neurologia Departmento Enfermedades Desmielinizantes
Buenos Aires, , Argentina
Seccion Neurolgia Instituto INEBA
Buenos Aires, , Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario, , Argentina
Dept Neurologia Sanatorio Britanico de Rosario
Rosario, , Argentina
OO Landes-Nervenklinik
Linz, , Austria
Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
Riberao Preto-SP, , Brazil
Dept of Neurology CHU Timone
Marseille, , France
Hopital Pontchaillou
Rennes, , France
Dept of Neurology Johannes Gutenberg University
Mainz, , Germany
Dept of Neurology Universitatsklinikum Munster
Münster, , Germany
Dept of Neurological and Psychiatric Sciences University of Bari
Bari, , Italy
Dept of Neurosciences Oftamology and Genetics Univ of Genoa
Genoa, , Italy
Dept Neurology Ospedale San Raffaele
Milan, , Italy
Dept of Neurological Sciences University La Sapienza Rome
Rome, , Italy
Academisch Ziekenhuis Vrije Universiteit
Amsterdam, , Netherlands
MS Center Nijmegen
Nijmegen, , Netherlands
City Clinical Hospital No 83
Moscow, , Russia
Dept Of Neurology and Neurosurgery, Russian State Med Univ
Moscow, , Russia
State Instituion Central Clinical Milatary Hospital
Moscow, , Russia
Scientific Research Center of Neurology Russian MOH
Moscow, , Russia
Department of Neurology City Hospital #33
Nizhny Novgorod, , Russia
Institute of Clinical Immunology RAMS
Novosibirsk, , Russia
Military Medical Academy
Saint Petersburg, , Russia
Dept of Neurology St Petersburg State Medical University
Saint Petersburg, , Russia
Dept of MS Institute for Human Brain of R.A.Sci
Saint Petersburg, , Russia
Dept of Neurology Medical Clinic of Russian MoH
Saint Petersburg, , Russia
Chair of Nuerological Diseases and Medical Genetics
Yaroslavl, , Russia
Neuroinmunologia Clinica Hospital Vall d'Hebron
Barcelona, , Spain
Servicio de Neurologia Hospital Bellvitge
L'Hospitalet de Llobregat, , Spain
Neurologia Hospital Carlos Haya
Málaga, , Spain
Unidad de EM Neurologia Hospital Virgen Macarena
Seville, , Spain
Dept Of Neurology
Zurich, , Switzerland
Department of Neurology
Whitechapel, London, United Kingdom
Department Of Neurology Royal London Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Div of Clinical Neurology B Floor Medical School Univ Hospital
Nottingham, , United Kingdom
Division of Clinical Neurology Medical School Universtity Hopsital
Nottingham, , United Kingdom
Countries
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References
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Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.
Other Identifiers
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24735
Identifier Type: -
Identifier Source: org_study_id
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