NCT00317941

Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif

The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Betaferon/Betaseron	250ug administrated with Betaject
DRUG	Rebif	44ug administered with Rebiject II
DRUG	Betaferon/Betaseron	250ug administrated with Betaject light

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-04-25
• Last updated: 2013-10-21
• Results posted: 2013-10-21

Locations

59 sites across 1 country: France