NCT00292253

Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,883 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram \[mcg\] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.

Conditions

• Multiple Sclerosis, Relapsing-remitting

Interventions

Type	Name	Description
DEVICE	Rebif® via Rebiject™Mini	Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
DEVICE	Rebif® via manual injections	Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.

Timeline

• Start date: 2001-01-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2006-02-15
• Last updated: 2013-08-06