This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.
Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups: * 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod, * 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or * 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
Fingolimod 0.5 mg capsules for oral administration once daily
Matching placebo in capsules for oral administration once daily.
Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment
Active lesions were measured on brain MRI scans, performed at week 8, compared to the prior scan. The primary variable was analyzed by fitting a negative binomial regression model adjusted for washout group.
Time frame: Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment
Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment
Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated from baseline to beginning of treatment.
Time frame: 8, 12 and 16 weeks (number of active T2 lesions during the washout period only)
Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment
Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated for first 8 weeks of fingolimod treatment.
Time frame: Number of active T2 lesions during 8 wks of fingolimod treatment
Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)
Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.
Time frame: Baseline up to 24 weeks
Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group
Kurtzke's Expanded Disability Status Scale (EDSS) measures the changes in neurologic impairment, either chronic (progression over time), or acute (MS relapses). The EDSS steps range from 0 (normal) to 10 (death due to MS). Relapse severity is assessed based on severity of neurologic impairment as evaluated using the EDSS.
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Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Teplice, Czechia
Novartis Investigative Site
Helsinki, Finland
Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, Germany
Novartis Investigative Site
Celle, Germany, Germany
Novartis Investigative Site
Bad Mergentheim, Germany
...and 34 more locations
Time frame: Baseline to week 16 and week 32
Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion
Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans
Time frame: 8 weeks and 24 weeks
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period
Adverse events were summarized by the number of patients having any adverse event overall.
Time frame: Baseline to maximum of 16 weeks
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment
Adverse events were summarized by the number of patients having any adverse event overall.
Time frame: Baseline to maximum of 16 weeks