Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis With Optional Extension Phase (TRANSFORMS)

This study will assess safety, tolerability and efficacy of two doses of oral fingolimod versus interferon Beta-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Official Title

A 12-Month Study Comparing the Efficacy and Safety of Two Doses of Fingolimod Versus Interferon Beta-1a in Patients With Relapsing-Remitting Multiple Sclerosis With Optional Extension Phase

Conditions

Multiple Sclerosis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Annualized relapse rate in patients with RRMS treated for up to 12 months

Secondary Outcome Measures:

• Proportion of relapse-free patients treated for up to 12 months
• Safety and tolerability of fingolimod in patients treated for up to 12 months
• Burden of disease and inflammatory activist as measured by MRI lesion parameters in patients treated for up to 12 months

Study Start

May 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 55 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Male and female patients between ages 18-55 with a diagnosis of MS
• Patients with a relapsing-remitting disease course
• Patients with EDSS score of 0-5.5

Exclusion Criteria:

• Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
• Pregnant or nursing women
• Patients who cannot tolerate treatment with an interferon

Total Enrolment

1275

Contact Details

• Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Cnr Goulburn and Campbell Street, Liverpool, New South Wales, 2170, Australia
• Royal Prince Alfred Hospital, Department of Medicine, Level, Missenden R, Camperdown, New South Wales, 2050, Australia
• St George Private Hospital, Suite 7E, Level 5, South Street, Kogarah, New South Wales, 2217, Australia
• Royal Melbourne Hospital, Suite 30, Grattan St., Parkbville, Victoria, 3050, Australia
• Box Hill Hopsital, Level 3, 16 Arnold Street, Box Hill, Victoria, 3128, Australia