| December 15, 2004 |
| December 18, 2008 |
| November 2003 |
| |
| Hazard ratio for relapses [ Time Frame: During the first and during the second 52 weeks ] |
| 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). |
| Complete list of historical versions of study NCT00099502 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| 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. |
| |
| BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients |
| 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. |
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
|
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Multiple Sclerosis, Relapsing-Remitting |
- Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
- Drug: Copaxone
|
| |
| 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. |
| |
| Completed |
| 2244 |
| August 2007 |
|
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
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
| |
| NCT00099502 |
| Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc. |
| 91162, EudraCT: 2005-002235-27, 306440, Beyond |
| Bayer |
|
| Study Director: |
Bayer Study Director |
Bayer |
|
|
| Bayer |
| December 2008 |