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.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01498887
First received: December 19, 2011
Last updated: May 8, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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: | January 2015 |
| Estimated Primary Completion Date: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498887
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Locations
| Australia, New South Wales | |
| Novartis Investigative Site | Not yet recruiting |
| Kanwal, New South Wales, Australia, 2259 | |
| Novartis Investigative Site | Not yet recruiting |
| Sydney, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| Novartis Investigative Site | Not yet recruiting |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, Victoria | |
| Novartis Investigative Site | Not yet recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Australia | |
| Novartis Investigative Site | Not yet recruiting |
| Brisbane Queensland, Australia, 4029 | |
| Spain | |
| Novartis Investigative Site | Not yet recruiting |
| Sevilla, Andalucia, Spain, 41009 | |
| Novartis Investigative Site | Not yet recruiting |
| Cordoba, Andalucía, Spain, 14004 | |
| Novartis Investigative Site | Not yet recruiting |
| Granada, Andalucía, Spain, 18012 | |
| Novartis Investigative Site | Not yet recruiting |
| Málaga, Andalucía, Spain, 29010 | |
| Novartis Investigative Site | Not yet recruiting |
| Sevilla, Andalucía, Spain, 41014 | |
| Novartis Investigative Site | Not yet recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Novartis Investigative Site | Not yet recruiting |
| Leon, Castilla y León, Spain, 24071 | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluna, Spain, 08035 | |
| Novartis Investigative Site | Not yet recruiting |
| Barcelona, Cataluna, Spain, 08025 | |
| Novartis Investigative Site | Not yet recruiting |
| Badalona, Catalunya, Spain, 08916 | |
| Novartis Investigative Site | Not yet recruiting |
| Barcelona, Catalunya, Spain, 08036 | |
| Novartis Investigative Site | Not yet recruiting |
| Tarragona, Cataluña, Spain, 43007 | |
| Novartis Investigative Site | Not yet recruiting |
| Valencia, Comunidad Valenciana, Spain, 46010 | |
| Novartis Investigative Site | Not yet recruiting |
| Ferrol, Galicia, Spain, 15405 | |
| Novartis Investigative Site | Not yet recruiting |
| La Coruna, Galicia, Spain, 15006 | |
| Novartis Investigative Site | Not yet recruiting |
| Vigo, Galicia, Spain, 36204 | |
| Novartis Investigative Site | Not yet recruiting |
| Palma De Mallorca, Islas Baleares, Spain | |
| Novartis Investigative Site | Not yet recruiting |
| Las Palmas de Gran Canarias, Las Palmas de G.C, Spain, 35012 | |
| Novartis Investigative Site | Not yet recruiting |
| Las Palmas de Gran Canarias, Las Palmas de G.C, Spain, 35016 | |
| Novartis Investigative Site | Not yet recruiting |
| Pamplona, Navarra, Spain, 31002 | |
| Novartis Investigative Site | Not yet recruiting |
| Barakaldo, País Vasco, Spain, 48903 | |
| Novartis Investigative Site | Not yet recruiting |
| Bilbao, País Vasco, Spain, 48013 | |
| Novartis Investigative Site | Not yet recruiting |
| Albacete, Spain, 02006 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28034 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28041 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28006 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28040 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28007 | |
| Novartis Investigative Site | Not yet recruiting |
| Santa Cruz de Tenerife, Spain, 38009 | |
| Novartis Investigative Site | Not yet recruiting |
| Santander, Spain, 39008 | |
| Novartis Investigative Site | Not yet recruiting |
| Valencia, Spain, 46017 | |
| Novartis Investigative Site | Not yet recruiting |
| Valencia, Spain, 46026 | |
| Novartis Investigative Site | Not yet recruiting |
| Valladolid, Spain, 47011 | |
| Novartis Investigative Site | Not yet recruiting |
| Zaragoza, Spain, 50009 | |
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: | May 8, 2013 |
| 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 Sclerosis Multiple Sclerosis, Relapsing-Remitting 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 June 17, 2013