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

NCT00078338 | Completed Phase 4 Results

• 1 other identifier: 24735
• Study Type: interventional
• Target: 764
• Locations: 12 countries
• Sites: 80

Brief 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.

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Time to First Relapse

  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

Study Arms (2)

Rebif®

EXPERIMENTAL

Drug: Rebif®

Copaxone®

ACTIVE COMPARATOR

Drug: Copaxone®

Interventions

Rebif® DRUG

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).

Also known as: Recombinant interferon beta-1a

Rebif®

Copaxone® DRUG

Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).

Also known as: Glatiramer acetate

Copaxone®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• EMD Serono: lead
• Pfizer: collaborator

Study Sites (80)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

Northwest NeuroSpecialists

Tucson, Arizona, 85741, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Kaiser Permanente Neurology

San Diego, California, 92102, United States

Location

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, 80528, United States

Location

The MS Treatment Center at Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Associated Neurologists of Southern Connecticut, P.C.

Fairfield, Connecticut, 06824, United States

Location

Neurological Center of South Florida

Miami, Florida, 33176, United States

Location

Harbourside Medical Plaza

Tampa, Florida, 33606, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

University Chicago Hospitals

Chicago, Illinois, 60619, United States

Location

Consultants In Neurology, Ltd.

Northbrook, Illinois, 60062, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46805, United States

Location

University of Maryland MD Center for MS

Baltimore, Maryland, 21201, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital Dept of Neurology

Detroit, Michigan, 48202, United States

Location

The Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

University of Minnesota Medical School, Dept of Neurology

Minneapolis, Minnesota, 55455, United States

Location

Nevada Neurological Consultants

Henderson, Nevada, 89052, United States

Location

Albany Medical College Dept of Neurology MC-70

Albany, New York, 12208, United States

Location

Neurology University of Rochester

Rochester, New York, 14642, United States

Location

SUNY At Stony Brook U Hospital - Department of Neurology

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University Dept of Neurology

Syracuse, New York, 13210, United States

Location

MS Center/CHS

Charlotte, North Carolina, 28207, United States

Location

Wake Forest Univ. Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oak Clinic for Multiple Sclerosis

Uniontown, Ohio, 44685, United States

Location

Medford Neurological and Spine Clinic

Medford, Oregon, 97504, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Physicians Dept of Neurology

Philadelphia, Pennsylvania, 19107, United States

Location

Baptist West Hospital

Knoxville, Tennessee, 37922, United States

Location

University of Texas-Houston

Houston, Texas, 77030, United States

Location

Central Texas Neurology

Round Rock, Texas, 78681, United States

Location

Neurology Health Care Service / Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Neurology Center of Fairfax

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Research Center

Roanoke, Virginia, 24014, United States

Location

Minor & James Medical, PLLC

Seattle, Washington, 98104, United States

Location

CAMC Institute

Charleston, West Virginia, 25304, United States

Location

Center for Neurological Disorders

Milwaukee, Wisconsin, 53215, United States

Location

Servicio de Neurologia

Buenos Aires, 1221, Argentina

Location

Departmento Enfermedades Desmielinizantes

Buenos Aires, 1428, Argentina

Location

Servicio de Neurologia Departmento Enfermedades Desmielinizantes

Buenos Aires, C118ACH, Argentina

Location

Seccion Neurolgia Instituto INEBA

Buenos Aires, C1192AAW, Argentina

Location

Fundacion Rosarina de Neurorehabilitacion

Rosario, CP 2000, Argentina

Location

Dept Neurologia Sanatorio Britanico de Rosario

Rosario, Argentina

Location

OO Landes-Nervenklinik

Linz, 4020, Austria

Location

Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo

Riberao Preto-SP, 14048-900, Brazil

Location

Dept of Neurology CHU Timone

Marseille, 13385, France

Location

Hopital Pontchaillou

Rennes, 35033, France

Location

Dept of Neurology Johannes Gutenberg University

Mainz, 55131, Germany

Location

Dept of Neurology Universitatsklinikum Munster

Münster, 48149, Germany

Location

Dept of Neurological and Psychiatric Sciences University of Bari

Bari, 70124, Italy

Location

Dept of Neurosciences Oftamology and Genetics Univ of Genoa

Genoa, 16132, Italy

Location

Dept Neurology Ospedale San Raffaele

Milan, Italy

Location

Dept of Neurological Sciences University La Sapienza Rome

Rome, 00185, Italy

Location

Academisch Ziekenhuis Vrije Universiteit

Amsterdam, 1081, Netherlands

Location

MS Center Nijmegen

Nijmegen, 6533 PA, Netherlands

Location

City Clinical Hospital No 83

Moscow, 115682, Russia

Location

Dept Of Neurology and Neurosurgery, Russian State Med Univ

Moscow, 117049, Russia

Location

State Instituion Central Clinical Milatary Hospital

Moscow, 123182, Russia

Location

Scientific Research Center of Neurology Russian MOH

Moscow, 125367, Russia

Location

Department of Neurology City Hospital #33

Nizhny Novgorod, 603076, Russia

Location

Institute of Clinical Immunology RAMS

Novosibirsk, 630099, Russia

Location

Military Medical Academy

Saint Petersburg, 194044, Russia

Location

Dept of Neurology St Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Dept of MS Institute for Human Brain of R.A.Sci

Saint Petersburg, 197376, Russia

Location

Dept of Neurology Medical Clinic of Russian MoH

Saint Petersburg, Russia

Location

Chair of Nuerological Diseases and Medical Genetics

Yaroslavl, 150030, Russia

Location

Neuroinmunologia Clinica Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Servicio de Neurologia Hospital Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Neurologia Hospital Carlos Haya

Málaga, 29010, Spain

Location

Unidad de EM Neurologia Hospital Virgen Macarena

Seville, 41009, Spain

Location

Dept Of Neurology

Zurich, 8091, Switzerland

Location

Department of Neurology

Whitechapel, London, E1 1BB, United Kingdom

Location

Department Of Neurology Royal London Hospital

London, E1 1BB, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Div of Clinical Neurology B Floor Medical School Univ Hospital

Nottingham, NG7 2UH, United Kingdom

Location

Division of Clinical Neurology Medical School Universtity Hopsital

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.

  PMID: 18789766 RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a; Glatiramer Acetate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2004
• First Posted: February 26, 2004
• Study Start: February 16, 2004
• Primary Completion: November 28, 2006
• Study Completion: November 28, 2006
• Last Updated: June 27, 2018
• Results First Posted: June 27, 2018

Record last verified: 2017-09

Locations

GB (5); IT (4); RU (11); BR (1); DE (2); US (41); AR (6); FR (2); NL (2); ES (4); CH (1); AU (1)