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Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT00078338•EMD Serono

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care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
+3 more criteria

Locations (80)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Key Dates

Start Date

February 16, 2004

Primary Completion Date

November 28, 2006

Completion Date

November 28, 2006

Last Updated

June 27, 2018

Enrollment

764

ACTUAL participants

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

Rebif®

DRUG

Copaxone®

DRUG

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831

Multiple SclerosisRelapsing-remitting Multiple Sclerosis

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RECRUITING

Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

NCT06586177

Relapsing-remitting Multiple Sclerosis

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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