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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Other Names Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Other Names Drug: Copaxone Other Names	Phase 3

Tracking Information

First Submitted Date	December 15, 2004
Last Update Posted Date	December 18, 2008
Start Date	November 01, 2003
Actual Completion Date	August 01, 2007
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Current 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]

Original Secondary Outcome Measures

Study Design

Brief Title	BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
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.
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 Type	Interventional
Study Phase	Phase 3
Estimated Enrollment	2244
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Triple
Primary Purpose	Treatment
Conditions	Multiple Sclerosis, Relapsing-Remitting
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 250mcg administered s.c. every other day Other Names Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 500mcg administered s.c. every other day Other Names Drug: Copaxone 20 mg administered s.c. once daily. Other Names
Study Groups/Cohorts	Arm 1 Arm 2 Arm 3
Study Arms	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.

Arm	Intervention/Treatment
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.

Recruitment Information

Recruitment Status:	Completed
Enrollment	2244
Completion Date	August 01, 2007
Eligibility 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
Gender	All
Age	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	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 United States

Administrative Information

NCT Number:	NCT00099502
Other Study ID Numbers	91162 EudraCT: 2005-002235-27 306440 Beyond NCT00185432
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	Therapeutic Area Head,
Study Sponsor	Bayer
Collaborators	Not Available
Investigators	Study Director Bayer Study Director Bayer