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

September 15, 2017 updated by: EMD Serono

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

764

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1221
        • Servicio de Neurologia
      • Buenos Aires, Argentina, 1428
        • Departmento Enfermedades Desmielinizantes
      • Buenos Aires, Argentina, C118ACH
        • Servicio de Neurologia Departmento Enfermedades Desmielinizantes
      • Buenos Aires, Argentina, C1192AAW
        • Seccion Neurolgia Instituto INEBA
      • Rosario, Argentina, CP 2000
        • Fundacion Rosarina de Neurorehabilitacion
      • Rosario, Argentina
        • Dept Neurologia Sanatorio Britanico de Rosario
  • Austria
      • Linz, Austria, 4020
        • OO Landes-Nervenklinik
  • Brazil
      • Riberao Preto-SP, Brazil, 14048-900
        • Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
  • France
      • Marseille, France, 13385
        • Dept of Neurology CHU Timone
      • Rennes cedex, France, 35033
        • Hôpital Pontchaillou
  • Germany
      • Mainz, Germany, 55131
        • Dept of Neurology Johannes Gutenberg University
      • Munster, Germany, 48149
        • Dept of Neurology Universitatsklinikum Munster
  • Italy
      • Bari, Italy, 70124
        • Dept of Neurological and Psychiatric Sciences University of Bari
      • Genoa, Italy, 16132
        • Dept of Neurosciences Oftamology and Genetics Univ of Genoa
      • Milan, Italy
        • Dept Neurology Ospedale San Raffaele
      • Rome, Italy, 00185
        • Dept of Neurological Sciences University La Sapienza Rome
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Academisch Ziekenhuis Vrije Universiteit
      • Nijmegen, Netherlands, 6533 PA
        • MS Center Nijmegen
  • Russian Federation
      • Moscow, Russian Federation, 115682
        • City Clinical Hospital No 83
      • Moscow, Russian Federation, 117049
        • Dept Of Neurology and Neurosurgery, Russian State Med Univ
      • Moscow, Russian Federation, 123182
        • State Instituion Central Clinical Milatary Hospital
      • Moscow, Russian Federation, 125367
        • Scientific Research Center of Neurology Russian MOH
      • Nizhniy Novgorod, Russian Federation, 603076
        • Department of Neurology City Hospital #33
      • Novosibirsk, Russian Federation, 630099
        • Institute of Clinical Immunology RAMS
      • Saint-Petersburg, Russian Federation, 194044
        • Military Medical Academy
      • St Petersburg, Russian Federation, 197022
        • Dept of Neurology St Petersburg State Medical University
      • St Petersburg, Russian Federation, 197376
        • Dept of MS Institute for Human Brain of R.A.Sci
      • St Petersburg, Russian Federation
        • Dept of Neurology Medical Clinic of Russian MoH
      • Yaroslavl, Russian Federation, 150030
        • Chair of Nuerological Diseases and Medical Genetics
  • Spain
      • Barcelona, Spain, 08035
        • Neuroinmunologia Clinica Hospital Vall d'Hebron
      • Hospitalet de Llobregat, Spain, 08907
        • Servicio de Neurologia Hospital Bellvitge
      • Malaga, Spain, 29010
        • Neurologia Hospital Carlos Haya
      • Sevilla, Spain, 41009
        • Unidad de EM Neurologia Hospital Virgen Macarena
  • Switzerland
      • Zurich, Switzerland, 8091
        • Dept Of Neurology
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Department Of Neurology Royal London Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Div of Clinical Neurology B Floor Medical School Univ Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Division of Clinical Neurology Medical School Universtity Hopsital
    • London
      • Whitechapel, London, United Kingdom, E1 1BB
        • Department of Neurology
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinics
      • Tucson, Arizona, United States, 85741
        • Northwest NeuroSpecialists
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Diego, California, United States, 92102
        • Kaiser Permanente Neurology
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurology of Colorado, LLC
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • The MS Treatment Center at Griffin Hospital
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern Connecticut, P.C.
    • Florida
      • Miami, Florida, United States, 33176
        • Neurological Center of South Florida
      • Tampa, Florida, United States, 33606
        • Harbourside Medical Plaza
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • Illinois
      • Chicago, Illinois, United States, 60619
        • University Chicago Hospitals
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology, Ltd.
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Neurological Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland MD Center for MS
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Dept of Neurology
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • The Minneapolis Clinic of Neurology
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical School, Dept of Neurology
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Nevada Neurological Consultants
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College Dept of Neurology MC-70
      • Rochester, New York, United States, 14642
        • Neurology University of Rochester
      • Stony Brook, New York, United States, 11794
        • SUNY At Stony Brook U Hospital - Department of Neurology
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Dept of Neurology
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • MS Center/CHS
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ. Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Uniontown, Ohio, United States, 44685
        • Oak Clinic for Multiple Sclerosis
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Neurological and Spine Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Physicians Dept of Neurology
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Baptist West Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas-Houston
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Neurology Health Care Service / Fletcher Allen Health Care
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Neurology Center of Fairfax
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Research Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Minor & James Medical, PLLC
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Center for Neurological Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rebif®
Drug: Rebif®
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).
Other Names:
  • Recombinant interferon beta-1a
ACTIVE_COMPARATOR: Copaxone®
Drug: Copaxone®
Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Other Names:
  • Glatiramer acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Relapse
Time Frame: Baseline up to 96 weeks
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.
Baseline up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 16, 2004

Primary Completion (ACTUAL)

November 28, 2006

Study Completion (ACTUAL)

November 28, 2006

Study Registration Dates

First Submitted

February 23, 2004

First Submitted That Met QC Criteria

February 25, 2004

First Posted (ESTIMATE)

February 26, 2004

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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