BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients - Full Text View

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 3

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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Glatiramer Interferon Beta-1b Glatiramer acetate

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 May 19, 2013