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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod (FTY720)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naive or de novo participants<br>Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. | Drug: Fingolimod (FTY720)<br>* Hard gelatin capsules containing 0.5 mg of fingolimod.<br>|
| Experimental: Previously treated with first-line DMTs participants<br>Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. | Drug: Fingolimod (FTY720)<br>* Hard gelatin capsules containing 0.5 mg of fingolimod.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Relapse Rate (ARR) | ARR = 365 days * number of relapses / total days taking the study medication. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Relapse | 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. | first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months | 
| Change From Baseline in Expanded Disability Status Scale (EDSS) Score | 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. | baseline, 12 months | 
| Change From Baseline in Cerebral Volume | Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement. | baseline, 12 months | 
| Percentage of Participants With Mild, Moderate or Severe Relapse | 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. | 12 months | 
| Percentage of Relapse-free Participants | 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. | 12 months | 
| Mean Number of T2 Active Lesions | The mean number of new or enlarged T2 active lesions was assessed by MRI. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fingolimod, Early multiple sclerosis, Naive patients