Clinical trial NCT00078338: Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2004-02-26
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care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

Primary outcomes:
measure: Time to First Relapse
timeFrame: Baseline up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurology Clinics
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists
state: Arizona
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Neurology
state: California
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado, LLC
state: Colorado
city: Derby
country: United States
facility: The MS Treatment Center at Griffin Hospital
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, P.C.
state: Connecticut
city: Miami
country: United States
facility: Neurological Center of South Florida
state: Florida
city: Tampa
country: United States
facility: Harbourside Medical Plaza
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: University Chicago Hospitals
state: Illinois
city: Northbrook
country: United States
facility: Consultants In Neurology, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland MD Center for MS
state: Maryland
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Dept of Neurology
state: Michigan
city: Golden Valley
country: United States
facility: The Minneapolis Clinic of Neurology
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical School, Dept of Neurology
state: Minnesota
city: Henderson
country: United States
facility: Nevada Neurological Consultants
state: Nevada
city: Albany
country: United States
facility: Albany Medical College Dept of Neurology MC-70
state: New York
city: Rochester
country: United States
facility: Neurology University of Rochester
state: New York
city: Stony Brook
country: United States
facility: SUNY At Stony Brook U Hospital - Department of Neurology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Dept of Neurology
state: New York
city: Charlotte
country: United States
facility: MS Center/CHS
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ. Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic for Multiple Sclerosis
state: Ohio
city: Medford
country: United States
facility: Medford Neurological and Spine Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Physicians Dept of Neurology
state: Pennsylvania
city: Knoxville
country: United States
facility: Baptist West Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: Burlington
country: United States
facility: Neurology Health Care Service / Fletcher Allen Health Care
state: Vermont
city: Fairfax
country: United States
facility: Neurology Center of Fairfax
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Research Center
state: Virginia
city: Seattle
country: United States
facility: Minor & James Medical, PLLC
state: Washington
city: Charleston
country: United States
facility: CAMC Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Center for Neurological Disorders
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Servicio de Neurologia
city: Buenos Aires
country: Argentina
facility: Departmento Enfermedades Desmielinizantes
city: Buenos Aires
country: Argentina
facility: Servicio de Neurologia Departmento Enfermedades Desmielinizantes
city: Buenos Aires
country: Argentina
facility: Seccion Neurolgia Instituto INEBA
city: Rosario
country: Argentina
facility: Fundacion Rosarina de Neurorehabilitacion
city: Rosario
country: Argentina
facility: Dept Neurologia Sanatorio Britanico de Rosario
city: Linz
country: Austria
facility: OO Landes-Nervenklinik
city: Riberao Preto-SP
country: Brazil
facility: Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo
city: Marseille
country: France
facility: Dept of Neurology CHU Timone
city: Rennes cedex
country: France
facility: Hopital Pontchaillou
city: Mainz
country: Germany
facility: Dept of Neurology Johannes Gutenberg University
city: Munster
country: Germany
facility: Dept of Neurology Universitatsklinikum Munster
city: Bari
country: Italy
facility: Dept of Neurological and Psychiatric Sciences University of Bari
city: Genoa
country: Italy
facility: Dept of Neurosciences Oftamology and Genetics Univ of Genoa
city: Milan
country: Italy
facility: Dept Neurology Ospedale San Raffaele
city: Rome
country: Italy
facility: Dept of Neurological Sciences University La Sapienza Rome
city: Amsterdam
country: Netherlands
facility: Academisch Ziekenhuis Vrije Universiteit
city: Nijmegen
country: Netherlands
facility: MS Center Nijmegen
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No 83
city: Moscow
country: Russian Federation
facility: Dept Of Neurology and Neurosurgery, Russian State Med Univ
city: Moscow
country: Russian Federation
facility: State Instituion Central Clinical Milatary Hospital
city: Moscow
country: Russian Federation
facility: Scientific Research Center of Neurology Russian MOH
city: Nizhniy Novgorod
country: Russian Federation
facility: Department of Neurology City Hospital #33
city: Novosibirsk
country: Russian Federation
facility: Institute of Clinical Immunology RAMS
city: Saint-Petersburg
country: Russian Federation
facility: Military Medical Academy
city: St Petersburg
country: Russian Federation
facility: Dept of Neurology St Petersburg State Medical University
city: St Petersburg
country: Russian Federation
facility: Dept of MS Institute for Human Brain of R.A.Sci
city: St Petersburg
country: Russian Federation
facility: Dept of Neurology Medical Clinic of Russian MoH
city: Yaroslavl
country: Russian Federation
facility: Chair of Nuerological Diseases and Medical Genetics
city: Barcelona
country: Spain
facility: Neuroinmunologia Clinica Hospital Vall d'Hebron
city: Hospitalet de Llobregat
country: Spain
facility: Servicio de Neurologia Hospital Bellvitge
city: Malaga
country: Spain
facility: Neurologia Hospital Carlos Haya
city: Sevilla
country: Spain
facility: Unidad de EM Neurologia Hospital Virgen Macarena
city: Zurich
country: Switzerland
facility: Dept Of Neurology
city: Whitechapel
country: United Kingdom
facility: Department of Neurology
state: London
city: London
country: United Kingdom
facility: Department Of Neurology Royal London Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Div of Clinical Neurology B Floor Medical School Univ Hospital
city: Nottingham
country: United Kingdom
facility: Division of Clinical Neurology Medical School Universtity Hopsital
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.