Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 6/29/2018 |
Start Date: | February 16, 2004 |
End Date: | November 28, 2006 |
Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
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.
(mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with
relapsing Multiple Sclerosis.
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understanding that consent may be withdrawn by the subject at any time without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.
We found this trial at
42
sites
100 Nicolls Road
Stony Brook, New York 11794
Stony Brook, New York 11794
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1 South Prospect Street
Burlington, Vermont 05401
Burlington, Vermont 05401
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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516 Delaware Street Southeast
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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130 South 9th Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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Minor and James Medical, PLLC In 1959 a group of the most respected physicians in...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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