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BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
This study has been completed.
First Received: December 15, 2004   Last Updated: December 18, 2008   History of Changes
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00099502
  Purpose

The purpose of this study is to determine

  • whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
  • whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Drug: Copaxone
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta Interferon-beta Interferon beta-1b Copolymer 1 Interferons
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Hazard ratio for relapses [ Time Frame: During the first and during the second 52 weeks ]

Secondary Outcome Measures:
  • Time to confirmed Expanded Disability Status Score (EDSS) progression [ Time Frame: After 52 and after 104 weeks ]
  • Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images [ Time Frame: After 104 weeks ]

Enrollment: 2244
Study Start Date: November 2003
Study Completion Date: August 2007
Arms Assigned Interventions
Arm 1: Experimental Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Arm 2: Experimental Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Arm 3: Active Comparator Drug: Copaxone
20 mg administered s.c. once daily.

Detailed Description:

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients
  • Aged 18-55 years
  • Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
  • Treatment-naive to IFNB or Copaxone

Exclusion Criteria:

  • Neurological progression at disease onset or between relapses
  • Serious or acute heart diseases
  • History of severe depression or suicide attempt
  • Serious or acute liver, renal or bone marrow dysfunction
  • Monoclonal gammopathy
  • Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099502

  Show 199 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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No publications provided

Responsible Party: Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers: 91162, EudraCT: 2005-002235-27, 306440, Beyond
Study First Received: December 15, 2004
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00099502     History of Changes
Health Authority: United States: Food and Drug Administration;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Brazil: Ministry of Health;   Canada: Health Canada;   Sweden: Medical Products Agency;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Brazil: Ministry of Health;   Canada: Health Canada;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Greece: Ministry of Health and Welfare;   Ireland: Irish Medicines Board;   Italy: Ministry of Health;   Latvia: State Agency of Medicines;   Netherlands: Dutch Health Care Inspectorate;   Norway: Norwegian Medicines Agency;   Poland: Ministry of Health;   Russia: Pharmacological Committee, Ministry of Health;   Slovenia: Ministry of Health;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Switzerland: Swissmedic;   Ukraine: Ministry of Health;   United States: Food and Drug Administration

Keywords provided by Bayer:
Relapsing multiple sclerosis
interferon beta 1b
Betaferon
Betaseron

Study placed in the following topic categories:
Interferon Type I, Recombinant
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic
Interferon-beta
Sclerosis
Immunosuppressive Agents
 Angiogenesis Inhibitors
Multiple Sclerosis, Relapsing-Remitting
Antiviral Agents
Copolymer 1
Multiple Sclerosis
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
 Demyelinating Diseases
Growth Substances
Interferons
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta
Sclerosis
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Copolymer 1
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS

ClinicalTrials.gov processed this record on July 02, 2009



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