NCT01633112

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,064 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Detailed description

This was a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS. This study consisted of 3 periods: * Screening Period: up to 45 days for all patients * Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg * Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015). Treatment groups: * fingolimod 0.5 mg/day orally for up to 12 months * fingolimod 0.25 mg/day orally for up to 12 months * glatiramer acetate 20 mg/day subcutaneously for up to 12 months

Conditions

• Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	fingolimod	capsule
DRUG	glatiramer acetate	subcutaneous injection

Timeline

• Start date: 2012-08-09
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2012-07-04
• Last updated: 2019-05-28
• Results posted: 2019-05-28

Locations

130 sites across 7 countries: United States, Argentina, Brazil, Canada, Chile, Mexico, Puerto Rico