Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Arms:
arm 1: Extension Treatment 250 mcg continued arm 2: Extension Treatment 500 mcg reduced to 250 mcg arm 3: Extension Treatment 500 mcg continued arm 4: Extension Treatment 250 mcg increased to 500 mcg

Interventions: intervention 1: Interferon beta 1b (Betaseron, BAY86-5046) intervention 2: Interferon beta 1b (Betaseron, BAY86-5046) intervention 3: Interferon beta 1b (Betaseron, BAY86-5046) intervention 4: Interferon beta 1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: 250 mcg administered s.c.(subcutaneous) every other day intervention 2: 250 mcg administered s.c. every other day (for patients having received 500 mcg before) intervention 3: 500 mcg administered s.c. every other day intervention 4: 500 mcg administered s.c. every other day (for patients having received 250 mcg before)

Protocol document: