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TOFIINGO

A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)
Stopped earlyPhase 3Relapsing MSNCT014996672011-001442-15

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Based on recent publications, determination of natalizumub washout period was no longer relevant.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment

Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment

GroupValueIntervalNumber analysed
8-week Washout + Fingolimod (FTY720)2.1 Count of Active T2 Lesions7.24 (Standard Deviation)41
12-week Washout + Fingolimod (FTY720)1.7 Count of Active T2 Lesions3.78 (Standard Deviation)29
16-week Washout + Fingolimod (FTY720)8.2 Count of Active T2 Lesions16.81 (Standard Deviation)39

8-week Washout + Fingolimod (FTY720)

2.1

12-week Washout + Fingolimod (FTY720)

1.7

16-week Washout + Fingolimod (FTY720)

8.2

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
8-week Washout + Fingolimod (FTY720)502 (4.0%)
12-week Washout + Fingolimod (FTY720)425 (11.9%)
16-week Washout + Fingolimod (FTY720)504 (8.0%)

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

  • Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment

    Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment

    MRI lesions

  • To evaluate disease control through MRI

    MRI lesions

Other measures (8)

  • Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment

    8, 12 and 16 weeks (number of active T2 lesions during the washout period only)

    MRI lesions

  • Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment

    Number of active T2 lesions during 8 wks of fingolimod treatment

    MRI lesions

  • Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)

    Baseline up to 24 weeks

    MRI lesions

  • Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group

    Baseline to week 16 and week 32

    Disability progressionRelapses

  • Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion

    8 weeks and 24 weeks

    MRI lesions

  • Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period

    Baseline to maximum of 16 weeks

    Safety

  • Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment

    Baseline to maximum of 16 weeks

    Safety

  • To evaluate disease control through MRI

    MRI lesions

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: Patients must: * Have relapsing remitting multiple sclerosis * Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option. Exclusion Criteria: Patients with: * History of chronic immune disease * Crohn's disease * Certain cancers * Uncontrolled diabetes * Certain eye disorders * Negative for varicella-zoster virus IgG antibodies * Certain hepatic conditions * Low white blood cell count * On certain immunosuppressive medications or heart medications * Resting heart rate less than 45 bpm. * Certain heart conditions or certain lung conditions * Inability to undergo MRI scans 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 evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Sept 2011

    2. Main results due

      Nov 2012

    3. Finished

      Nov 2012

    4. Results posted

      Apr 2014

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