NCT01128075

Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS). Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks. The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.

Conditions

• Multiple Sclerosis
• MS

Interventions

Type	Name	Description
DEVICE	RebiSmart™	Electronic self-injection device (RebiSmart™) to inject Rebif®
DEVICE	RebiSmart™	Electronic self-injection device (RebiSmart™) to inject Rebif®

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-05-21
• Last updated: 2014-07-09

Locations

1 site across 1 country: Canada