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A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
CompletedPhase 3Relapsing MSNCT00340834

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“The annualized relapse rate was significantly lower in both groups receiving fingolimod--0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group--than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P<0.001 for both comparisons).”
Read by software from the paper's abstract

annualized relapse rate · 12 months

p = <0.001 for both comparisons

Total participants: 1292

Read by software from the paper's abstract

What was tested

Treatment tested

Compared with

  • Interferon β-1a 30 µg

Results by group

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study

Baseline to Month 12

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg0.203 Estimate relapses per year0.157–0.264420
Fingolimod 0.5 mg0.161 Estimate relapses per year0.122–0.212429
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg0.331 Estimate relapses per year0.262–0.417431

Fingolimod 1.25 mg

0.203

Fingolimod 0.5 mg

0.161

Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg

0.331

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
COR FTY720 1.25 mg42045 (10.7%)
COR FTY720 0.5 mg42930 (7.0%)
COR Interferon Beta-1a43125 (5.8%)
EXT FTY720 1.25 mg50477 (15.3%)
EXT FTY720 0.5 mg52376 (14.5%)

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

  • Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study

    Baseline to Month 12

    Disability progressionRelapses

Other measures (5)

  • Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study

    Baseline to Month 12

    MRI lesions

  • 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

    Baseline to Month 12

    Disability progressionBladder, bowel and sexual function

  • Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study

    Month 0 to end of study (up to approximately 4.5 years)

    Disability progressionRelapses

  • Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study

    Month 12 to end of study (up to approximately 3.5 years)

    MRI lesions

  • 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

    Baseline to end of study (up to approximately 4.5 years)

    Disability progressionBladder, bowel and sexual function

Who could take part

Relapsing MS · 18 to 55

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.

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

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      May 2006

    2. Main results due

      Jul 2011

    3. Finished

      Jul 2011

    4. Results posted

      May 2011

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