Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis RRMS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

Detailed description:
Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms:
arm 1: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject arm 2: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light arm 3: Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II

Interventions: intervention 1: Betaferon/Betaseron intervention 2: Rebif intervention 3: Betaferon/Betaseron
Intervention descriptions: intervention 1: 250ug administrated with Betaject intervention 2: 44ug administered with Rebiject II intervention 3: 250ug administrated with Betaject light

Protocol document: