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Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
CompletedPhase 3Relapsing MSNCT006626492007-004122-24

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“In the continuous-fingolimod groups, ARR was lower (p < 0.0001), BVL was reduced (p < 0.05), and proportionately more patients were free from 3-month CDP (p < 0.05) than in a group comprising all placebo-fingolimod patients.”
Read by software from the paper's abstract

p = < 0.0001

Total participants: 920

Read by software from the paper's abstract

What was tested

Treatment tested

Results by group

Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)

Months 0 to end of study (maximum up to 60 months)

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg0.164 Relapses per year0.138–0.195429
Fingolimod 0.5 mg0.185 Relapses per year0.158–0.217425
Placebo-fingolimod0.357 Relapses per year0.31–0.411418

Fingolimod 1.25 mg

0.164

Fingolimod 0.5 mg

0.185

Placebo-fingolimod

0.357

Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free

Core baseline to end of study (maximum up to 60 months)

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg59.85 Percentage of patients53.9–65.8429
Fingolimod 0.5 mg59.29 Percentage of patients54.17–64.41425
Placebo-fingolimod37.18 Percentage of patients32.15–42.22418

Fingolimod 1.25 mg

59.85

Fingolimod 0.5 mg

59.29

Placebo-fingolimod

37.18

Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)

Months 0-24 (core study) and Months 24-48 (extension study)

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg0.064 Relapses per year0.043–0.094287
Fingolimod 0.5 mg0.111 Relapses per year0.084–0.148330
Placebo-fingolimod 1.25 mg0.301 Relapses per year0.23–0.393145
Placebo-fingolimod 0.5 mg0.292 Relapses per year0.222–0.383154
Fingolimod 1.25 mg0.074 Relapses per year0.051–0.108287
Fingolimod 0.5 mg0.095 Relapses per year0.07–0.128330
Placebo-fingolimod 1.25 mg0.164 Relapses per year0.117–0.231145
Placebo-fingolimod 0.5 mg0.130 Relapses per year0.092–0.184154

Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)

Months 0-24 (core study) and Months 24-48 (extension study)

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg1.164 Ratio of relapses per year0.83–1.633287
Fingolimod 0.5 mg0.850 Ratio of relapses per year0.658–1.099330
Placebo-fingolimod 1.25 mg0.547 Ratio of relapses per year0.39–0.767145
Placebo-fingolimod 0.5 mg0.446 Ratio of relapses per year0.32–0.62154

Fingolimod 1.25 mg

1.164

Fingolimod 0.5 mg

0.85

Placebo-fingolimod 1.25 mg

0.547

Placebo-fingolimod 0.5 mg

0.446

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Fingolimod 1.25mg28931 (10.7%)
Fingolimod 0.5mg33131 (9.4%)
Placebo-Fingolimod 1.25mg14517 (11.7%)
Placebo-Fingolimod 0.5mg15511 (7.1%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)

    Months 0 to end of study (maximum up to 60 months)

    Relapses

  • Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free

    Core baseline to end of study (maximum up to 60 months)

    Disability progressionRelapsesBladder, bowel and sexual function

  • Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)

    Months 0-24 (core study) and Months 24-48 (extension study)

    Relapses

  • Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)

    Months 0-24 (core study) and Months 24-48 (extension study)

    Relapses

  • - Safety:

    Safety

Other measures (5)

  • 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)

    Months 0-24 (core study) and Months 24-48 (extension study)

    MRI lesions

  • 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)

    Months 0-24 (core study) and Months 24-48 (extension study)

    MRI lesions

  • Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)

    Months 0-24 (core study) and Months 24-48 (extension study)

    MRI lesionsBrain volume loss

  • Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)

    Months 0 to end of study (maximum up to 60 months)

    MRI lesionsBrain volume loss

  • 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

    Core baseline to end of study (maximum up to 60 months)

    Disability progressionBladder, bowel and sexual function

Who could take part

Relapsing MS · 20 to 58

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

Loading reviews and guidelines…

Linked trials

  • Extension of

    FREEDOMS

    Phase 3 · Completed

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Feb 2008

    2. Main results due

      Jun 2011

    3. Finished

      Jun 2011

    4. Results posted

      Jul 2012

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