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

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078338
• Other study ID #: 24735
• Status: Completed
• Phase: Phase 4
• Start date: February 16, 2004
• Est. completion date: November 28, 2006

Study information

• Verified date: September 2017
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: November 28, 2006
• Est. primary completion date: November 28, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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-ß, 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  France,  Germany,  Italy,  Netherlands,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

References & 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 Aceta — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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