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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-remitting Multiple Sclerosis

Intervention: Human interferon beta-1a and glatiramer acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Bruno Musch, MD, Study Director, Affiliation: EMD Serono

Summary

The primary objective of the study is to assess the clinical efficacy of Rebif 44 mcg three times per week compared with Copaxone 20 mg daily in patients with relapsing Multiple Sclerosis.

Clinical Details

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 design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to first relapse.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

- 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

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 MS or primary progressive MS.

- Prior use of any interferon or glatiramer acetate.

- Have had treatment with oral or systemic corticosteroids or ACTH within 4 weeks of

Study Day 1 and within 7 days prior to the Day 1 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 (AST, 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 DTPA.

- 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, HIV, HTLV-1).

- Have had plasma exchange in 3 months prior to Study Day 1.

Locations and Contacts

Departmento Enfermedades Desmielinizantes, Buenos Aires 1428, Argentina

Seccion Neurolgia Instituto INEBA, Buenos Aires C1192AAW, Argentina

Servicio de Neurologia, Buenos Aires 1221, Argentina

Servicio de Neurologia Departmento Enfermedades Desmielinizantes, Buenos Aires C118ACH, Argentina

Dept Neurologia Sanatorio Britanico de Rosario, Rosario, Argentina

Fundacion Rosarina de Neurorehabilitacion, Rosario CP 2000, Argentina

OO Landes-Nervenklinik, Linz 4020, Austria

Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo, Riberao Preto-SP 14048-900, Brazil

Dept of Neurology CHU Timone, Marseille 13385, France

Hopital Pontchaillou, Rennes cedex 35033, France

Dept of Neurology Johannes Gutenberg University, Mainz 55131, Germany

Dept of Neurology Universitatsklinikum Munster, Munster 48149, Germany

Dept of Neurological and Psychiatric Sciences University of Bari, Bari 70124, Italy

Dept of Neurosciences Oftamology and Genetics Univ of Genoa, Genoa 16132, Italy

Dept Neurology Ospedale San Raffaele, Milan, Italy

Dept of Neurological Sciences University La Sapienza Rome, Rome 00185, Italy

Academisch Ziekenhuis Vrije Universiteit, Amsterdam 1081, Netherlands

MS Center Nijmegen, Nijmegen 6533 PA, Netherlands

City Clinical Hospital No 83, Moscow 115682, Russian Federation

Dept Of Neurology and Neurosurgery, Russian State Med Univ, Moscow 117049, Russian Federation

Scientific Research Center of Neurology Russian MOH, Moscow 125367, Russian Federation

State Instituion Central Clinical Milatary Hospital, Moscow 123182, Russian Federation

Department of Neurology City Hospital #33, Nizhniy Novgorod 603076, Russian Federation

Institute of Clinical Immunology RAMS, Novosibirsk 630099, Russian Federation

Military Medical Academy, Saint-Petersburg 194044, Russian Federation

Dept of MS Institute for Human Brain of R.A.Sci, St Petersburg 197376, Russian Federation

Dept of Neurology Medical Clinic of Russian MoH, St Petersburg, Russian Federation

Dept of Neurology St Petersburg State Medical University, St Petersburg 197022, Russian Federation

Chair of Nuerological Diseases and Medical Genetics, Yaroslavl 150030, Russian Federation

Neuroinmunologia Clinica Hospital Vall d'Hebron, Barcelona 08035, Spain

Servicio de Neurologia Hospital Bellvitge, Hospitalet de Llobregat 08907, Spain

Neurologia Hospital Carlos Haya, Malaga 29010, Spain

Unidad de EM Neurologia Hospital Virgen Macarena, Sevilla 41009, Spain

Dept Of Neurology, Zurich 8091, Switzerland

Department Of Neurology Royal London Hospital, London E1 1BB, United Kingdom

Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, United Kingdom

Div of Clinical Neurology B Floor Medical School Univ Hospital, Nottingham NG7 2UH, United Kingdom

Division of Clinical Neurology Medical School Universtity Hopsital, Nottingham NG7 2UH, United Kingdom

University of Alabama at Birmingham, Birmingham, Alabama 35249, United States

Barrow Neurology Clinics, Phoenix, Arizona 85013, United States

Northwest NeuroSpecialists, Tucson, Arizona 85741, United States

University of California, Davis, Sacramento, California 95817, United States

Kaiser Permanente Neurology, San Diego, California 92102, United States

Advanced Neurology of Colorado, LLC, Fort Collins, Colorado 80528, United States

The MS Treatment Center at Griffin Hospital, Derby, Connecticut 06418, United States

Associated Neurologists of Southern Connecticut, P.C., Fairfield, Connecticut 06824, United States

Neurological Center of South Florida, Miami, Florida 33176, United States

Harbourside Medical Plaza, Tampa, Florida 33606, United States

Shepherd Center, Atlanta, Georgia 30309, United States

University Chicago Hospitals, Chicago, Illinois 60619, United States

Consultants In Neurology, Ltd., Northbrook, Illinois 60062, United States

Fort Wayne Neurological Center, Fort Wayne, Indiana 46805, United States

Department of Neurology, Whitechapel, London E1 1BB, United Kingdom

University of Maryland MD Center for MS, Baltimore, Maryland 21201, United States

University Of Michigan, Ann Arbor, Michigan 48109, United States

Henry Ford Hospital Dept of Neurology, Detroit, Michigan 48202, United States

Wayne State University, Detroit, Michigan 48201, United States

The Minneapolis Clinic of Neurology, Golden Valley, Minnesota 55422, United States

University of Minnesota Medical School, Dept of Neurology, Minneapolis, Minnesota 55455, United States

Nevada Neurological Consultants, Henderson, Nevada 89052, United States

Albany Medical College Dept of Neurology MC-70, Albany, New York 12208, United States

Neurology University of Rochester, Rochester, New York 14642, United States

SUNY At Stony Brook U Hospital - Department of Neurology, Stony Brook, New York 11794, United States

SUNY Upstate Medical University Dept of Neurology, Syracuse, New York 13210, United States

MS Center/CHS, Charlotte, North Carolina 28207, United States

Wake Forest Univ. Health Sciences, Winston Salem, North Carolina 27157, United States

Ohio State University, Columbus, Ohio 43210, United States

Oak Clinic for Multiple Sclerosis, Uniontown, Ohio 44685, United States

Medford Neurological and Spine Clinic, Medford, Oregon 97504, United States

Thomas Jefferson University Physicians Dept of Neurology, Philadelphia, Pennsylvania 19107, United States

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Baptist West Hospital, Knoxville, Tennessee 37922, United States

University of Texas-Houston, Houston, Texas 77030, United States

Central Texas Neurology, Round Rock, Texas 78681, United States

Neurology Health Care Service / Fletcher Allen Health Care, Burlington, Vermont 05401, United States

Neurology Center of Fairfax, Fairfax, Virginia 22031, United States

Blue Ridge Research Center, Roanoke, Virginia 24014, United States

Minor & James Medical, PLLC, Seattle, Washington 98104, United States

CAMC Institute, Charleston, West Virginia 25304, United States

Center for Neurological Disorders, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: March 2004
Last updated: August 5, 2014

Page last updated: August 20, 2015

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