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

Tracking Information

First Received Date ^ICMJE

December 15, 2004

Last Updated Date

December 18, 2008

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Prime objective: For IFNB-1b, comparison of a 500µg (16 MIU) dose to the currently approved dose (250 µg; 8 MIU), s.c. e.o.d., with regard to safety, tolerability and efficacy in patients with relapsing remitting MS (RRMS).

Change History

Complete list of historical versions of study NCT00099502 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Co-prime objective: Comparison of the safety, tolerability and efficacy of IFNB-1b e.o.d. and Copaxone 20 mg given s.c. o.d.; Time to confirmed EDSS progression; MRI: Change from screening in volume of black holes after 104 weeks.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Drug: Copaxone

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2244

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00099502

Responsible Party

Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.

Study ID Numbers ^ICMJE

91162, EudraCT: 2005-002235-27, 306440, Beyond

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP