Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Novartis281 enrolled

Overview

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

281

Conditions

Multiple Sclerosis

Interventions

FTY720DRUG

FTY720 capsule was taken orally once a day

PlaceboDRUG

Placebo 1.25 mg capsule was given once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Core Study Inclusion Criteria: * Diagnosis of relapsing multiple Sclerosis (MS) * Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year * Patients with an Expanded Disability Status Scale (EDSS) score of 0-6 Extension Study * A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later) * Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods. * Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period. Exclusion Criteria: Core Study * Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc * Pregnant or nursing women Extension Study * Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study * Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study) Other protocol-defined inclusion/exclusion criteria may apply

Locations (26)

Novartis Investigational site

Montreal, Canada

Outcomes

Primary Outcomes

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

Time frame: Month 6 (Core)

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

Time frame: Month 12 (extension)

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

Time frame: Month 60 (extension)

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: Last observation (Up to 80 months in average)

Secondary Outcomes

Percentage of Participants Free of T1-weighted Lesions

A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novartis Investigational site

Ottawa, Canada

Novartis Investigational site

Toronto, Canada

Novartis Investigational site

Vancouver, Canada

Novartis Investigational site

Copenhagen, Denmark

Novartis Investigational site

Helsinki, Finland

Novartis Investigational site

Turku, Finland

Novartis Investigational site

Lille, France

Novartis Investigational site

Marseille, France

Novartis Investigational site

Schwendi, Germany

...and 16 more locations

Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit

A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: Month 6 and 12, 60, last observation (up to 80 months in average)

Mean Number of New T2-weighted Lesions

New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

Volume of T2-weighted Lesions

Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

Change From Baseline in Volume of Total T2-weighted Lesions

Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.

Time frame: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)

Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients

The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Time frame: Month 6,12,60 and Last observation (up to 80 months in average)

Mean Trough Blood Concentrations of FTY720

For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient's steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.

Time frame: Month 3 and 6