Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy (EARLiMS)

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Fingolimod (FTY720)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498887

CFTY720DES03

2011-003484-30 (EudraCT Number)

Details and patient eligibility

About

This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.

Enrollment: 347 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
• Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

• Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
• Previously treated with a first-line Disease Modifying Therapy

Exclusion criteria

• Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

• Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

Naive or de novo participants

Experimental group

Description:

Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Treatment:

Drug: Fingolimod (FTY720)

Previously treated with first-line DMTs participants

Experimental group

Description:

Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Treatment:

Drug: Fingolimod (FTY720)