NCT00428584

RNF and Betaseron® Tolerability Study

A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.

Conditions

• Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	New Formulation of rebif - human interferon beta-1a	New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
DRUG	Interferon beta -1b	Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-11-01
• Completion: 2009-09-01
• First posted: 2007-01-30
• Last updated: 2013-08-07
• Results posted: 2010-03-04

Locations

1 site across 1 country: United States