NCT00078338

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

Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 764 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Rebif®	Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).
DRUG	Copaxone®	Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).

Timeline

• Start date: 2004-02-16
• Primary completion: 2006-11-28
• Completion: 2006-11-28
• First posted: 2004-02-26
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

80 sites across 12 countries: United States, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russia, Spain, Switzerland, United Kingdom