MSFrontier

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.
CompletedPhase 3Relapsing MSNCT00099502

What it found

Missed its main goal

The main measure did not show a significant benefit.

“We found no differences in relapse risk, EDSS progression, T1-hypointense lesion volume, or normalised brain volume among treatment groups.”
Read by software from the paper's abstract

relapse risk · 2.0-3.5 years

Total participants: 2244

Read by software from the paper's abstract

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Hazard ratio for relapses

    During the first and during the second 52 weeks

    Relapses

Other measures (2)

  • Time to confirmed Expanded Disability Status Score (EDSS) progression

    After 52 and after 104 weeks

    Disability progression

  • Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images

    After 104 weeks

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Related trials

History

    1. Started

      Nov 2003

    2. Finished

      Aug 2007

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