Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Completed · Phase 4

Conditions studied: Relapsing-remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT00078338
Run by: EMD Serono
People needed: 764
Starts: 2004-02-16
Expected to finish: 2006-11-28
Last updated by the study team: 2018-06-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care

You may not qualify if…

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.

Where it is running

Barrow Neurology Clinics — Phoenix, Arizona, United States
Northwest NeuroSpecialists — Tucson, Arizona, United States
University of California, Davis — Sacramento, California, United States
Kaiser Permanente Neurology — San Diego, California, United States
Advanced Neurology of Colorado, LLC — Fort Collins, Colorado, United States
The MS Treatment Center at Griffin Hospital — Derby, Connecticut, United States
Associated Neurologists of Southern Connecticut, P.C. — Fairfield, Connecticut, United States
Neurological Center of South Florida — Miami, Florida, United States
Harbourside Medical Plaza — Tampa, Florida, United States
Shepherd Center — Atlanta, Georgia, United States
University Chicago Hospitals — Chicago, Illinois, United States
Consultants In Neurology, Ltd. — Northbrook, Illinois, United States
Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
University of Maryland MD Center for MS — Baltimore, Maryland, United States
University Of Michigan — Ann Arbor, Michigan, United States
Wayne State University — Detroit, Michigan, United States
Henry Ford Hospital Dept of Neurology — Detroit, Michigan, United States
The Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
University of Minnesota Medical School, Dept of Neurology — Minneapolis, Minnesota, United States
Nevada Neurological Consultants — Henderson, Nevada, United States
Albany Medical College Dept of Neurology MC-70 — Albany, New York, United States
Neurology University of Rochester — Rochester, New York, United States
SUNY At Stony Brook U Hospital - Department of Neurology — Stony Brook, New York, United States
SUNY Upstate Medical University Dept of Neurology — Syracuse, New York, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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