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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 )

Tracking Information
First Submitted Date  ICMJE December 19, 2011
First Posted Date  ICMJE December 26, 2011
Results First Submitted Date  ICMJE October 25, 2017
Results First Posted Date  ICMJE January 25, 2019
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE December 24, 2011
Actual Primary Completion Date December 26, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Annual Relapse Rate (ARR) [ Time Frame: 12 months ]
ARR = 365 days * number of relapses / total days taking the study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
Difference on Annual Relapse Rate for both groups [ Time Frame: 12 months ]
The annual relapse rate will be calculate for both groups based on the number of patients examined, total number of relapses for all patients and the total of days that the subject take the medication
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Mean Number of T2 Active Lesions [ Time Frame: 12 months ]
    The mean number of new or enlarged T2 active lesions was assessed by MRI.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
  • Time to first relapse [ Time Frame: 12 month ]
    A Kaplan-Meier method will be used to calculate time to first relapse in both groups, indicating the percentage of release-free patients at month 12 for naive and pre-treated patients
  • Disability progression [ Time Frame: 12 month ]
    Differences between Expanded Disability Status Scale score in naive patients versus and pre-treated ones compare to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE Drug: Fingolimod (FTY720)
Hard gelatin capsules containing 0.5 mg of fingolimod.
Study Arms  ICMJE
  • Experimental: Naive or de novo participants
    Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
    Intervention: Drug: Fingolimod (FTY720)
  • Experimental: Previously treated with first-line DMTs participants
    Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
    Intervention: Drug: Fingolimod (FTY720)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
347
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)
432
Actual Study Completion Date  ICMJE December 26, 2015
Actual Primary Completion Date December 26, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498887
Other Study ID Numbers  ICMJE CFTY720DES03
2011-003484-30 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP