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

Bayer

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Relapsing-Remitting

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099502

EudraCT: 2005-002235-27

306440

91162

Beyond

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,244 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2,244 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

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

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

Arm 2

Experimental group

Treatment:

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

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

Arm 3

Active Comparator group

Treatment:

Drug: Copaxone