Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care Exclusion Criteria: Have secondary progressive multiple sclerosis (SPMS) or primary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.
Sites / Locations
- University of Alabama at Birmingham
- Barrow Neurology Clinics
- Northwest NeuroSpecialists
- University of California, Davis
- Kaiser Permanente Neurology
- Advanced Neurology of Colorado, LLC
- The MS Treatment Center at Griffin Hospital
- Associated Neurologists of Southern Connecticut, P.C.
- Neurological Center of South Florida
- Harbourside Medical Plaza
- Shepherd Center
- University Chicago Hospitals
- Consultants In Neurology, Ltd.
- Fort Wayne Neurological Center
- University of Maryland MD Center for MS
- University Of Michigan
- Wayne State University
- Henry Ford Hospital Dept of Neurology
- The Minneapolis Clinic of Neurology
- University of Minnesota Medical School, Dept of Neurology
- Nevada Neurological Consultants
- Albany Medical College Dept of Neurology MC-70
- Neurology University of Rochester
- SUNY At Stony Brook U Hospital - Department of Neurology
- SUNY Upstate Medical University Dept of Neurology
- MS Center/CHS
- Wake Forest Univ. Health Sciences
- Ohio State University
- Oak Clinic for Multiple Sclerosis
- Medford Neurological and Spine Clinic
- University Of Pennsylvania
- Thomas Jefferson University Physicians Dept of Neurology
- Baptist West Hospital
- University of Texas-Houston
- Central Texas Neurology
- Neurology Health Care Service / Fletcher Allen Health Care
- Neurology Center of Fairfax
- Blue Ridge Research Center
- Minor & James Medical, PLLC
- CAMC Institute
- Center for Neurological Disorders
- Servicio de Neurologia
- Departmento Enfermedades Desmielinizantes
- Servicio de Neurologia Departmento Enfermedades Desmielinizantes
- Seccion Neurolgia Instituto INEBA
- Fundacion Rosarina de Neurorehabilitacion
- Dept Neurologia Sanatorio Britanico de Rosario
- OO Landes-Nervenklinik
- Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
- Dept of Neurology CHU Timone
- Hopital Pontchaillou
- Dept of Neurology Johannes Gutenberg University
- Dept of Neurology Universitatsklinikum Munster
- Dept of Neurological and Psychiatric Sciences University of Bari
- Dept of Neurosciences Oftamology and Genetics Univ of Genoa
- Dept Neurology Ospedale San Raffaele
- Dept of Neurological Sciences University La Sapienza Rome
- Academisch Ziekenhuis Vrije Universiteit
- MS Center Nijmegen
- City Clinical Hospital No 83
- Dept Of Neurology and Neurosurgery, Russian State Med Univ
- State Instituion Central Clinical Milatary Hospital
- Scientific Research Center of Neurology Russian MOH
- Department of Neurology City Hospital #33
- Institute of Clinical Immunology RAMS
- Military Medical Academy
- Dept of Neurology St Petersburg State Medical University
- Dept of MS Institute for Human Brain of R.A.Sci
- Dept of Neurology Medical Clinic of Russian MoH
- Chair of Nuerological Diseases and Medical Genetics
- Neuroinmunologia Clinica Hospital Vall d'Hebron
- Servicio de Neurologia Hospital Bellvitge
- Neurologia Hospital Carlos Haya
- Unidad de EM Neurologia Hospital Virgen Macarena
- Dept Of Neurology
- Department of Neurology
- Department Of Neurology Royal London Hospital
- Royal Victoria Infirmary
- Div of Clinical Neurology B Floor Medical School Univ Hospital
- Division of Clinical Neurology Medical School Universtity Hopsital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rebif®
Copaxone®