Phase 3
N=1,083
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00355134 ↗Enrolled (actual)
1,083
Serious AEs
11.6%
Results posted
Jun 2012
Primary outcome: Primary: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 — 0.203; 0.208; 0.403 relapses per year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fingolimod (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 |
0.203; 0.208; 0.403 | — |
| SECONDARY Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study |
0.180; 0.192; 0.363 | — |
| SECONDARY Percent Change From Baseline in Brain Volume |
-0.595; -0.858; -1.279; -1.130; -1.266; -1.694 | — |
| SECONDARY Number of New or Newly Enlarged T2 Lesions |
1.6; 2.3; 8.9; 0.63; 0.45; 0.63 | — |
| SECONDARY Number of Gadolinium-enhanced T1 Lesions |
0.24; 0.37; 1.22; 0.46; 0.09; 0.45 | — |
| SECONDARY Change From Baseline in Lesion Volume at Month 24 (Core Phase) |
-436.92; -223.27; 541.83; -99.13; -111.28; -37.68 | — |
| SECONDARY Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study |
78.3; 74.7; 71.0; 66.64; 58.89; 63.51 | — |
| SECONDARY Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study |
86.9; 86.2; 82.2; 79.92; 74.89; 75.03 | — |
| SECONDARY Percentage of Participants Relapse-free up to Month 24 |
73.2; 71.5; 52.7 | — |
| SECONDARY Percentage of Participants Relapse-free up to End of Study |
63.88; 66.57; 49.12 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score |
-0.08; 0.00; -0.07; 0.011; -0.091; 0.019 | — |
Summary
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
Eligibility Criteria
Inclusion Criteria
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- 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
For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00355134). 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.