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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01498887
First received: December 19, 2011
Last updated: June 4, 2014
Last verified: June 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Difference on Annual Relapse Rate for both groups [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Differences between Expanded Disability Status Scale score in naive patients versus and pre-treated ones compare to baseline


Estimated Enrollment: 434
Study Start Date: December 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498887

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 48 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01498887     History of Changes
Other Study ID Numbers: CFTY720DES03, 2011-003484-30
Study First Received: December 19, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ministry of Health

Keywords provided by Novartis:
Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Fingolimod
Early multiple sclerosis
Naive patients

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014