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

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ClinicalTrials.gov Identifier: NCT01498887
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Fingolimod (FTY720) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : December 24, 2011
Actual Primary Completion Date : December 26, 2015
Actual Study Completion Date : December 26, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naive or de novo participants
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Drug: Fingolimod (FTY720)
Hard gelatin capsules containing 0.5 mg of fingolimod.

Experimental: Previously treated with first-line DMTs participants
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Drug: Fingolimod (FTY720)
Hard gelatin capsules containing 0.5 mg of fingolimod.




Primary Outcome Measures :
  1. Annual Relapse Rate (ARR) [ Time Frame: 12 months ]
    ARR = 365 days * number of relapses / total days taking the study medication.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498887


  Show 47 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01498887     History of Changes
Other Study ID Numbers: CFTY720DES03
2011-003484-30 ( EudraCT Number )
First Posted: December 26, 2011    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Fingolimod
Early multiple sclerosis
Naive patients
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs