Phase 3
Completed N=1,272
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00662649 ↗Enrolled (actual)
1,272
Serious AEs
9.8%
Results posted
Jul 2012
Primary outcomePrimary: Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study) — 0.164; 0.185; 0.357 Relapses per year
Summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study) |
0.164; 0.185; 0.357 | — |
| PRIMARY Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free |
59.85; 59.29; 37.18 | — |
| PRIMARY Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study) |
0.064; 0.111; 0.301; 0.292; 0.074; 0.095 | — |
| PRIMARY Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study) |
1.164; 0.850; 0.547; 0.446 | — |
| SECONDARY Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study) |
2.14; 2.66; 12.83; 8.12; 1.71; 2.58 | — |
| SECONDARY Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study) |
53.2; 50.3; 18.5; 23.2; 57.1; 69.3 | — |
| SECONDARY Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study) |
-1.011; -0.983; -1.511; -1.419; -0.871; -0.780 | — |
| SECONDARY Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study) |
-1.639; -1.674; -2.241 | — |
| SECONDARY Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression |
74.15; 73.90; 66.28 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should complete the 24 month core study
Exclusion Criteria
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00662649). 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.