RNF and Betaseron® Tolerability Study

Phase 3 Completed 129 enrolled EMD Serono Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2006-12
Primary completion: 2007-11
Completion: 2009-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); New Formulation of Rebif vs Betaseron; p = 0.524; ANOVA; note: P value refers to mean change to 30 minute post injection NCT00428584 ↗

paper Mean (standard deviation) change in VAS diary pain score was not significantly different between groups, although numerically lower with IFNβ-1a versus IFNβ-1b PMID 23216674 ↗

Publications

Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F; REFORMS Study Group. Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonbeta-1a versus subcutaneous interferonbeta-1b: results of the randomized, multicenter, Phase IIIb REFORMS study. BMC Neurol. 2012 Dec 6;12:154. doi: 10.1186/1471-2377-12-154.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Interferon beta-1b	Protein / enzyme biologic	250 ug	Subcutaneous
Subject	human interferon beta 1a	Unknown	44 ug	Subcutaneous