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Clinical Trial Summary

RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.


Clinical Trial Description

This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).

OBJECTIVES

Primary objective:

- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge

Secondary objectives:

- To assess effectiveness and convenience of treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01108887
Study type Observational
Source Merck KGaA
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date January 2013

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