Phase 3
Completed N=1,292
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Source: ClinicalTrials.gov NCT00340834 ↗Enrolled (actual)
1,292
Serious AEs
11.0%
Results posted
May 2011
Primary outcomePrimary: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study — 0.203; 0.161; 0.331 Estimate relapses per year
Summary
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study |
0.203; 0.161; 0.331 | — |
| SECONDARY Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study |
1.6; 1.6; 2.6 | — |
| SECONDARY Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study |
93.3; 94.1; 92.1 | — |
| SECONDARY Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study |
0.156; 0.182; 0.266; 0.116; 0.110; 0.121 | — |
| SECONDARY Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study |
1.08; 0.87; 0.97; 1.40; 1.04; 0.72 | — |
| SECONDARY Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study |
67.01; 71.28; 73.40; 79.54; 79.76; 81.61 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
- Patients with a relapsing-remitting disease course
- Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5
Exclusion Criteria
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
- Pregnant or nursing women
- Patients who cannot tolerate treatment with an interferon
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00340834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.