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EARLiMS

A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.
CompletedPhase 4Relapsing MSNCT014988872011-003484-30

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Annual Relapse Rate (ARR) 0.3118

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Annual Relapse Rate (ARR)

12 months

GroupValueIntervalNumber analysed
Naive or de Novo Participants0.290 Relapses per year0.7399 (Standard Deviation)185
Previously Treated With First-line DMTs Participants0.354 Relapses per year0.8547 (Standard Deviation)135

Naive or de Novo Participants

0.29

Previously Treated With First-line DMTs Participants

0.354

p = 0.3118

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Naive or de Novo Participants20011 (5.5%)
Previously Treated With First-line DMTs Participants1474 (2.7%)
All Participants34715 (4.3%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annual Relapse Rate (ARR)

    12 months

    Relapses

  • To assess whether naïve4 treatment with 0.5 mg fingolimod in patients with short duration relapsing-remitting multiple sclerosis (less than five years) is superior in reducing the annual relapse rate, compared with treatment with 0.5 mg fingolimod in patients with the same disease and duration who have previously received first-line treatments

    Relapses

Other measures (7)

  • Time to First Relapse

    first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months

    Relapses

  • Change From Baseline in Expanded Disability Status Scale (EDSS) Score

    baseline, 12 months

    Disability progression

  • Change From Baseline in Cerebral Volume

    baseline, 12 months

    MRI lesions

  • Percentage of Participants With Mild, Moderate or Severe Relapse

    12 months

    Relapses

  • Percentage of Relapse-free Participants

    12 months

    Relapses

  • Mean Number of T2 Active Lesions

    12 months

    MRI lesions

  • ? To describe the effect of fingolimod on cerebral atrophy through changes in cerebral volume in both groups (naïve patients and patients previously treated with first-line DMTs). Since not all participating centres have the SIENAX software, the analysis of all MRIs will be applicable only for a subpopulation of subjects.

    Brain volume loss

Who could take part

Relapsing MS · 18 to 50

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Dec 2011

      2. Main results due

        Dec 2015

      3. Finished

        Dec 2015

      4. Results posted

        Jan 2019

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