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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 on December 15, 2004.   Last Updated on December 18, 2008   History of Changes
Sponsor: 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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Experimental: Arm 1 Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Experimental: Arm 2 Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Active Comparator: Arm 3 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:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group; O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Harung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. Epub 2009 Sep 2.

Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00099502     History of Changes
Obsolete Identifiers: NCT00185432
Other Study ID Numbers: 91162, EudraCT: 2005-002235-27, 306440, Beyond
Study First Received: December 15, 2004
Last Updated: December 18, 2008
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: Finnish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Denmark: Danish Medicines 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;   Switzerland: Swissmedic;   Ukraine: Ministry of Health

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

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

ClinicalTrials.gov processed this record on February 09, 2012



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