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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099502
• Other study ID #: 91162
• Secondary ID: EudraCT: 2005-00
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2004
• Last updated: December 18, 2008
• Start date: November 2003
• Est. completion date: August 2007

Study information

• Verified date: December 2008
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of HealthCanada: Health CanadaSweden: Medical Products AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareIreland: Irish Medicines BoardItaly: Ministry of HealthLatvia: State Agency of MedicinesNetherlands: Dutch Health Care InspectorateNorway: Norwegian Medicines AgencyPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSlovenia: Ministry of HealthSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00185432

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2244
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
• Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
• Copaxone
20 mg administered s.c. once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard ratio for relapses		During the first and during the second 52 weeks
Secondary	Time to confirmed Expanded Disability Status Score (EDSS) progression		After 52 and after 104 weeks
Secondary	Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images		After 104 weeks

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