The primary objective of the study is to assess the clinical efficacy of Rebif® 44 mcg three times per week compared with Copaxone® 20 mg daily in patients with relapsing Multiple Sclerosis.

Condition	Treatment or Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Human interferon beta-1a and glatiramer acetate	Phase IV

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

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.
• 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 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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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 MS or primary progressive MS.
• Prior use of any interferon or glatiramer acetate.
• Have had treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 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 (AST, 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 DTPA.
• 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, HIV, HTLV-1).
• Have had plasma exchange in 3 months prior to Study Day 1.

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35249,  United States; Recruiting
Arizona
      Northwest NeuroSpecialists, Tucson,  Arizona,  85741,  United States; Recruiting
      Barrow Neurology Clinics, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      University of California, Davis, Sacramento,  California,  95817,  United States; Recruiting
      Kaiser Permanente Neurology, San Diego,  California,  92102,  United States; Recruiting
Colorado
      Advanced Neurology of Colorado, LLC, Fort Collins,  Colorado,  80528,  United States; Recruiting
Connecticut
      Associated Neurologists of Southern Connecticut, P.C., Fairfield,  Connecticut,  06824,  United States; Recruiting
      The MS Treatment Center at Griffin Hospital, Derby,  Connecticut,  06418,  United States; Recruiting
Florida
      Harbourside Medical Plaza, Tampa,  Florida,  33606,  United States; Recruiting
      Neurological Center of South Florida, Miami,  Florida,  33176,  United States; Recruiting
Georgia
      Shepherd Center, Atlanta,  Georgia,  30309,  United States; Recruiting
Illinois
      Consultants In Neurology, Ltd., Northbrook,  Illinois,  60062,  United States; Recruiting
      University Chicago Hospitals, Chicago,  Illinois,  60619,  United States; Recruiting
Indiana
      Fort Wayne Neurological Center, Fort Wayne,  Indiana,  46805,  United States; Recruiting
Maryland
      University of Maryland MD Center for MS, Baltimore,  Maryland,  21201,  United States; Recruiting
Michigan
      University Of Michigan, Ann Arbor,  Michigan,  48109,  United States; Recruiting
      Wayne State University, Detroit,  Michigan,  48201,  United States; Recruiting
      Henry Ford Hospital Dept of Neurology, Detroit,  Michigan,  48202,  United States; Recruiting
Minnesota
      The Minneapolis Clinic of Neurology, Golden Valley,  Minnesota,  55422,  United States; Recruiting
      University of Minnesota Medical School, Dept of Neurology, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Nevada
      Nevada Neurological Consultants, Henderson,  Nevada,  89052,  United States; Recruiting
New York
      Albany Medical College Dept of Neurology MC-70, Albany,  New York,  12208,  United States; Recruiting
      Neurology University of Rochester, Rochester,  New York,  14642,  United States; Recruiting
      SUNY Upstate Medical University Dept of Neurology, Syracuse,  New York,  13210,  United States; Recruiting
      SUNY At Stony Brook U Hospital - Department of Neurology, Stony Brook,  New York,  11794,  United States; Recruiting
North Carolina
      MS Center/CHS, Charlotte,  North Carolina,  28207,  United States; Recruiting
      Wake Forest Univ. Health Sciences, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
      Oak Clinic for Multiple Sclerosis, Uniontown,  Ohio,  44685,  United States; Recruiting
Oregon
      Medford Neurological and Spine Clinic, Medford,  Oregon,  97504,  United States; Recruiting
Pennsylvania
      Thomas Jefferson University Physicians Dept of Neurology, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      University Of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Tennessee
      Baptist West Hospital, Knoxville,  Tennessee,  37922,  United States; Recruiting
Texas
      Central Texas Neurology, Round Rock,  Texas,  78681,  United States; Recruiting
      University of Texas-Houston, Houston,  Texas,  77030,  United States; Recruiting
Vermont
      Neurology Health Care Service / Fletcher Allen Health Care, Burlington,  Vermont,  05401,  United States; Recruiting
Virginia
      Neurology Center of Fairfax, Fairfax,  Virginia,  22031,  United States; Recruiting
      Blue Ridge Research Center, Roanoke,  Virginia,  24014,  United States; Recruiting
Washington
      Minor & James Medical, PLLC, Seattle,  Washington,  98104,  United States; Recruiting
West Virginia
      CAMC Institute, Charleston,  West Virginia,  25304,  United States; Recruiting
Wisconsin
      Center for Neurological Disorders, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  24735
Record last reviewed:  October 2004
Record first received:  February 23, 2004
ClinicalTrials.gov Identifier:  NCT00078338
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10