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

Novartis

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Fingolimod 0.5 mg; Drug: Fingolimod 1.25 mg; Drug: Interferon β-1a 30 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00340834

CFTY720D2302E1 (Other Identifier)

CFTY720D2302

Details and patient eligibility

About

This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Enrollment: 1,292 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
• Patients with a relapsing-remitting disease course
• Patients with Expanded Disability Status Scale (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

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,292 participants in 3 patient groups

Fingolimod 1.25 mg

Experimental group

Treatment:

Drug: Fingolimod 1.25 mg

Fingolimod 0.5 mg

Experimental group

Treatment:

Drug: Fingolimod 0.5 mg

Interferon β-1a 30 µg

Active Comparator group

Treatment:

Drug: Interferon β-1a 30 µg