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
Overview
- Phase
- Phase 3
- Intervention
- fingolimod
- Conditions
- Relapsing-remitting Multiple Sclerosis (RRMS)
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1064
- Locations
- 1
- Primary Endpoint
- Confirmed Annualized Relapse Rate
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
fingolimod 0.5 mg
orally once daily
Intervention: fingolimod
fingolimod 0.25mg
orally once daily
Intervention: fingolimod
glatiramer acetate 20 mg
subcutaneous once daily
Intervention: glatiramer acetate
Outcomes
Primary Outcomes
Confirmed Annualized Relapse Rate
Time Frame: up to 12 months
Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.
Secondary Outcomes
- Change From Baseline in T2 Lesion Volume(Baseline, 12 months/end of study)
- Percentage of Patients Free of New T1 Hypointense Lesions(12 months)
- New or Newly Enlarging T2 Lesions(At 12 months/end of study)
- Gd Enhancing T1 Lesion Volume(Baseline, 12 months/end of study)
- Gd Enhancing T1 Lesion Count(At 12 months/end of study)
- Number of Participants Free of New/Newly Enlarged T2 Lesions(At 12 months/end of study)
- Change From Baseline in TSQM Scales(6 months, 12 months/end of study)
- Percent Brain Volume Change From Baseline(Baseline, 12 months, end of study)