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

Phase 3

Terminated

Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions: Drug: glatiramer acetate
Drug: fingolimod

Registration Number: NCT01633112

Lead Sponsor: Novartis Pharmaceuticals

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1064

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glatiramer acetate 20 mg	glatiramer acetate	subcutaneous once daily
fingolimod 0.5 mg	fingolimod	orally once daily
fingolimod 0.25mg	fingolimod	orally once daily

Primary Outcome Measures

Name	Time	Method
Confirmed Annualized Relapse Rate	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 Outcome Measures

Name	Time	Method
Change From Baseline in T2 Lesion Volume	Baseline, 12 months/end of study	Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume
Percentage of Patients Free of New T1 Hypointense Lesions	12 months	Based on MRI measures of new T1 hypointense lesions
New or Newly Enlarging T2 Lesions	At 12 months/end of study	Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Gd Enhancing T1 Lesion Volume	Baseline, 12 months/end of study	Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Gd Enhancing T1 Lesion Count	At 12 months/end of study	Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Number of Participants Free of New/Newly Enlarged T2 Lesions	At 12 months/end of study	Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Change From Baseline in TSQM Scales	6 months, 12 months/end of study	Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.
Percent Brain Volume Change From Baseline	Baseline, 12 months, end of study	Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.