Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT00078338
- Lead Sponsor
- EMD Serono
- Brief Summary
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 764
- Be between 18 and 60 years of age
- 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
- Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Copaxone® Copaxone® - Rebif® Rebif® -
- Primary Outcome Measures
Name Time Method Time to First Relapse Baseline up to 96 weeks Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (80)
Dept of Neurology St Petersburg State Medical University
🇷🇺St Petersburg, Russian Federation
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Minor & James Medical, PLLC
🇺🇸Seattle, Washington, United States
Neurological Center of South Florida
🇺🇸Miami, Florida, United States
Kaiser Permanente Neurology
🇺🇸San Diego, California, United States
University of Minnesota Medical School, Dept of Neurology
🇺🇸Minneapolis, Minnesota, United States
Albany Medical College Dept of Neurology MC-70
🇺🇸Albany, New York, United States
SUNY Upstate Medical University Dept of Neurology
🇺🇸Syracuse, New York, United States
Neurology University of Rochester
🇺🇸Rochester, New York, United States
University of Maryland MD Center for MS
🇺🇸Baltimore, Maryland, United States
Thomas Jefferson University Physicians Dept of Neurology
🇺🇸Philadelphia, Pennsylvania, United States
The MS Treatment Center at Griffin Hospital
🇺🇸Derby, Connecticut, United States
Central Texas Neurology
🇺🇸Round Rock, Texas, United States
Department of Neurology
🇬🇧Whitechapel, London, United Kingdom
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Nevada Neurological Consultants
🇺🇸Henderson, Nevada, United States
Division of Clinical Neurology Medical School Universtity Hopsital
🇬🇧Nottingham, United Kingdom
Servicio de Neurologia Hospital Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
OO Landes-Nervenklinik
🇦🇹Linz, Austria
State Instituion Central Clinical Milatary Hospital
🇷🇺Moscow, Russian Federation
Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
🇧🇷Riberao Preto-SP, Brazil
Institute of Clinical Immunology RAMS
🇷🇺Novosibirsk, Russian Federation
Departmento Enfermedades Desmielinizantes
🇦🇷Buenos Aires, Argentina
Dept of Neurology Universitatsklinikum Munster
🇩🇪Munster, Germany
Neurology Center of Fairfax
🇺🇸Fairfax, Virginia, United States
Dept of Neurological Sciences University La Sapienza Rome
🇮🇹Rome, Italy
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Department Of Neurology Royal London Hospital
🇬🇧London, United Kingdom
Academisch Ziekenhuis Vrije Universiteit
🇳🇱Amsterdam, Netherlands
Dept of Neurosciences Oftamology and Genetics Univ of Genoa
🇮🇹Genoa, Italy
City Clinical Hospital No 83
🇷🇺Moscow, Russian Federation
SUNY At Stony Brook U Hospital - Department of Neurology
🇺🇸Stony Brook, New York, United States
Dept Neurology Ospedale San Raffaele
🇮🇹Milan, Italy
Servicio de Neurologia
🇦🇷Buenos Aires, Argentina
Barrow Neurology Clinics
🇺🇸Phoenix, Arizona, United States
Harbourside Medical Plaza
🇺🇸Tampa, Florida, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital Dept of Neurology
🇺🇸Detroit, Michigan, United States
Center for Neurological Disorders
🇺🇸Milwaukee, Wisconsin, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwest NeuroSpecialists
🇺🇸Tucson, Arizona, United States
Advanced Neurology of Colorado, LLC
🇺🇸Fort Collins, Colorado, United States
University Chicago Hospitals
🇺🇸Chicago, Illinois, United States
The Minneapolis Clinic of Neurology
🇺🇸Golden Valley, Minnesota, United States
MS Center/CHS
🇺🇸Charlotte, North Carolina, United States
Oak Clinic for Multiple Sclerosis
🇺🇸Uniontown, Ohio, United States
Baptist West Hospital
🇺🇸Knoxville, Tennessee, United States
University of Texas-Houston
🇺🇸Houston, Texas, United States
Neurology Health Care Service / Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
CAMC Institute
🇺🇸Charleston, West Virginia, United States
Seccion Neurolgia Instituto INEBA
🇦🇷Buenos Aires, Argentina
Servicio de Neurologia Departmento Enfermedades Desmielinizantes
🇦🇷Buenos Aires, Argentina
Dept of Neurology CHU Timone
🇫🇷Marseille, France
Dept of Neurology Johannes Gutenberg University
🇩🇪Mainz, Germany
Dept of Neurological and Psychiatric Sciences University of Bari
🇮🇹Bari, Italy
Hopital Pontchaillou
🇫🇷Rennes cedex, France
MS Center Nijmegen
🇳🇱Nijmegen, Netherlands
Dept Of Neurology and Neurosurgery, Russian State Med Univ
🇷🇺Moscow, Russian Federation
Department of Neurology City Hospital #33
🇷🇺Nizhniy Novgorod, Russian Federation
Scientific Research Center of Neurology Russian MOH
🇷🇺Moscow, Russian Federation
Military Medical Academy
🇷🇺Saint-Petersburg, Russian Federation
Dept Of Neurology
🇨🇭Zurich, Switzerland
Dept of MS Institute for Human Brain of R.A.Sci
🇷🇺St Petersburg, Russian Federation
Chair of Nuerological Diseases and Medical Genetics
🇷🇺Yaroslavl, Russian Federation
Neuroinmunologia Clinica Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Dept of Neurology Medical Clinic of Russian MoH
🇷🇺St Petersburg, Russian Federation
Neurologia Hospital Carlos Haya
🇪🇸Malaga, Spain
Unidad de EM Neurologia Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Div of Clinical Neurology B Floor Medical School Univ Hospital
🇬🇧Nottingham, United Kingdom
Dept Neurologia Sanatorio Britanico de Rosario
🇦🇷Rosario, Argentina
Consultants In Neurology, Ltd.
🇺🇸Northbrook, Illinois, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸Fairfield, Connecticut, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Blue Ridge Research Center
🇺🇸Roanoke, Virginia, United States
Fundacion Rosarina de Neurorehabilitacion
🇦🇷Rosario, Argentina
Medford Neurological and Spine Clinic
🇺🇸Medford, Oregon, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Univ. Health Sciences
🇺🇸Winston-Salem, North Carolina, United States