Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Phase 4 Completed 764 enrolled EMD Serono Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Timeline

Start: 2004-02-16
Primary completion: 2006-11-28
Completion: 2006-11-28

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Rebif® vs Copaxone®; p = 0.643; Hazard Ratio (HR) 0.943 (95% CI 0.74 to 1.21); Cox proportional hazards model NCT00078338 ↗

paper There was no significant difference between interferon beta-1a and glatiramer acetate in the primary outcome. PMID 18789766 ↗

Publications

Results Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glatiramer Acetate	Small molecule	20 mg	Subcutaneous
Subject	Interferon beta-1a	Protein / enzyme biologic	44 ug	Subcutaneous