NCT02019550

Rebif® Rebidose® Versus Rebiject II® Ease-of-Use

A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DEVICE	Rebif Rebidose	Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.
DEVICE	Rebiject II	Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-12-24
• Last updated: 2017-03-07
• Results posted: 2017-03-07

Locations

21 sites across 1 country: United States