A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study

Outcome Description:

The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.

Outcome Time Frame:

Baseline to Month 12

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmacuticals

Authority:

United States: Food and Drug Administration

Study ID:

CFTY720D2302

NCT ID:

NCT00340834

Start Date:

May 2006

Completion Date:

July 2011

Related Keywords:

• Multiple Sclerosis
• FTY720
• Interferon
• RRMS
• Multiple Sclerosis
• Efficacy
• Multiple Sclerosis
• Sclerosis
• Multiple Sclerosis, Relapsing-Remitting