ong-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis

Conditions: multiple sclerosis
MedDRA version: 18.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-002660-17-PT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 281

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
2. Randomized in study FTY720D2201 and received at least one dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 266
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Patients not meeting the inclusion criteria are excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether continuous use of fingolimod over 10 years reduces the progression of disability, as measured by the mean Expanded Disability Status Scale (EDSS) score, compared to shorter treatment duration;Secondary Objective: 1. Additional assessments of the development of disability from disease onset and from start of treatment in D2201<br>2. Assessment of change in MRI measures<br>3. Assessment of novel MRI measures at 10 years<br>4. Correlational analyses – duration of treatment with clinical outcomes, MRI measures with clinical outcomes, cognitive measures with MRI outcomes. Atrophy measures comparing results with old MRI scanner and new MRI scanner at<br>10 years (for sites with access to the D2201/2201E1 MRI scanner)<br>;Primary end point(s): the change from baseline (D2201 baseline) in EDSS score at the 10-year follow-up visit;Timepoint(s) of evaluation of this end point: 10 year since starting study (FTY720D2201)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of patients with disability progression at 10 years will be summarized<br>-Change in MRI measures at 10 year follow up <br>-New MRI measures (deep gey matter volume, corical thickness, T1 hypointense lesion black hole” volume) will be<br>measured at 10 year follow up <br>-Correlative analysis (treatment duration and clinical outcomes; MRI measures and clinical outcomes; cognitive measures and MRI outcomes; atrophy measures between old and new MRI scans) will be done at 10 year follow up <br>;Timepoint(s) of evaluation of this end point: 10 year since starting study (FTY720D2201)