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FREEDOMS II

24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
CompletedPhase 3Relapsing MSNCT00355134

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“Mean annualised relapse rate was 0·40 (95% CI 0·34-0·48) in patients given placebo and 0·21 (0·17-0·25) in patients given fingolimod 0·5 mg: rate ratio 0·52 (95% CI 0·40-0·66; p<0·0001), corresponding to a reduction of 48% with fingolimod 0·5 mg versus placebo.”
Read by software from the paper's abstract

Annualised relapse rate at month 24 · 24 months

GroupnValue
Placebo3550.40 (95% CI 0.34-0.48)
Fingolimod 0·5 mg3580.21 (0.17-0.25)

rate ratio 0.52

p = <0.0001

Total participants: 1083

Read by software from the paper's abstract

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24

24 months

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg0.203 relapses per year0.165–0.249370
Fingolimod 0.5 mg0.208 relapses per year0.17–0.254358
Placebo0.403 relapses per year0.342–0.475355

Fingolimod 1.25 mg

0.203

Fingolimod 0.5 mg

0.208

Placebo

0.403

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Core: Fingolimod 1.25 mg37053 (14.3%)
Core: Fingolimod 0.5 mg35853 (14.8%)
Core: Placebo35545 (12.7%)
Extension: Fingolimod 1.25 mg30827 (8.8%)
Extension: Fingolimod 0.5 mg32421 (6.5%)

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

  • Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24

    24 months

    Disability progressionRelapses

Other measures (10)

  • Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study

    From Baseline until end of study (up to approximately 54 months).

    Disability progressionRelapses

  • Percent Change From Baseline in Brain Volume

    Baseline, Month 24 and end of study (up to approximately 54 months)

    MRI lesionsBrain volume loss

  • Number of New or Newly Enlarged T2 Lesions

    From Baseline until Month 48

    MRI lesions

  • Number of Gadolinium-enhanced T1 Lesions

    Month 24 and end of study (up to approximately 54 months)

    MRI lesions

  • Change From Baseline in Lesion Volume at Month 24 (Core Phase)

    Baseline and Month 24

    MRI lesions

  • Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study

    24 months and end of study (up to approximately 54 months)

    Disability progression

  • Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study

    24 months and end of study (up to approximately 54 months)

    Disability progression

  • Percentage of Participants Relapse-free up to Month 24

    24 months

    Relapses

  • Percentage of Participants Relapse-free up to End of Study

    From Baseline until the end of study (up to approximately 54 months)

    Relapses

  • Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score

    Baseline, Month 24 and end of study (up to approximately 54 months)

    Disability progressionThinking and memoryWalking and mobilityArm and hand 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 * 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.

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 two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

Papers

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Related trials

History

    1. Started

      Jun 2006

    2. Main results due

      Jun 2011

    3. Finished

      Aug 2011

    4. Results posted

      Jun 2012

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