Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Rebif®; Copaxone®
Intervention description: 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).; Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Glatiramer Acetate; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 764.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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.
    

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.