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Efficacy of Fingolimod in de ...

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

Last Updated: 2019-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-24

Study Completion Date

2015-12-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naive or de novo participants

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

Group Type EXPERIMENTAL

Fingolimod (FTY720)

Intervention Type DRUG

Hard gelatin capsules containing 0.5 mg of fingolimod.

Previously treated with first-line DMTs participants

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

Group Type EXPERIMENTAL

Fingolimod (FTY720)

Intervention Type DRUG

Hard gelatin capsules containing 0.5 mg of fingolimod.

Interventions

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Fingolimod (FTY720)

Hard gelatin capsules containing 0.5 mg of fingolimod.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers