NCT00958009

The Multicenter, Open-label, Single-use Autoinjector Convenience Study

A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of a Ready-to-use, Single-use Autoinjector (SA) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc), Three Times a Week (Tiw)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Rebidose®	The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2009-08-13
• Last updated: 2013-08-07
• Results posted: 2010-12-30

Locations

1 site across 1 country: United States