Status:
COMPLETED
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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), versu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2015
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01498887
Start Date
December 24 2011
End Date
December 26 2015
Last Update
January 25 2019
Active Locations (47)
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1
Novartis Investigative Site
East Gosford, New South Wales, Australia, 2250
2
Novartis Investigative Site
Kanwal, New South Wales, Australia, 2259
3
Novartis Investigative Site
Liverpool, New South Wales, Australia, 2170
4
Novartis Investigative Site
New Lambton Heights, New South Wales, Australia, 2305