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

Phase 4

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: Fingolimod (FTY720)

Registration Number: NCT01498887

Lead Sponsor: Novartis Pharmaceuticals

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), versus patients with the same disease duration who had previously received first-line DMTs.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 347

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previously treated with first-line DMTs participants	Fingolimod (FTY720)	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Naive or de novo participants	Fingolimod (FTY720)	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Primary Outcome Measures

Name	Time	Method
Annual Relapse Rate (ARR)	12 months	ARR = 365 days \* number of relapses / total days taking the study medication.

Secondary Outcome Measures

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