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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498887
First Posted: December 26, 2011
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who have not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who have previously received first-line Disease Modifying Therapies.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: Fingolimod (FTY720) Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Difference on Annual Relapse Rate for both groups [ Time Frame: 12 month ]
    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


Secondary Outcome Measures:
  • 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


Enrollment: 349
Actual Study Start Date: December 21, 2011
Study Completion Date: December 23, 2015
Primary Completion Date: December 23, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod
Both groups of patients in the study will be treated in parallel with Fingolimod.
Drug: Fingolimod (FTY720)
Fingolimod will be used in two group of patients with treatment different characteristics at baseline

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01498887     History of Changes
Other Study ID Numbers: CFTY720DES03
2011-003484-30 ( EudraCT Number )
First Submitted: December 19, 2011
First Posted: December 26, 2011
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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