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NCT Number: NCT01498887

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

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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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, East Gosford, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fingolimod (FTY720)

Drug

Hard gelatin capsules containing 0.5 mg of fingolimod.

Primary outcomes

  1. Annual Relapse Rate (ARR)

    Time frame: 12 months

    ARR = 365 days * number of relapses / total days taking the study medication.

Secondary outcomes

  1. Time to First Relapse

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

    Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.

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

    Time frame: baseline, 12 months

    The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.

  3. Change From Baseline in Cerebral Volume

    Time frame: baseline, 12 months

    Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.

  4. Percentage of Participants With Mild, Moderate or Severe Relapse

    Time frame: 12 months

    The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.

  5. Percentage of Relapse-free Participants

    Time frame: 12 months

    Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.

  6. Mean Number of T2 Active Lesions

    Time frame: 12 months

    The mean number of new or enlarged T2 active lesions was assessed by MRI.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Acronym: EARLiMS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 26, 2011
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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