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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002660-17-IT

Enrollment

281

Registered

2014-02-17

Start date

2014-04-09

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis MedDRA version: 16.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D Pharmaceutical Form: Capsule, hard INN or Proposed INN: Fingolimod CAS Number: 162359-56-0 Current Sponsor code: FTY720D Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Patients not meeting the inclusion criteria are excluded.

Design outcomes

Primary

Measure	Time frame
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 2. Assessment of change in MRI measures 3. Assessment of novel MRI measures at 10 years 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 10 years (for sites with access to the D2201/2201E1 MRI scanner) ;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)	—

Measure

Time frame

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 2. Assessment of change in MRI measures 3. Assessment of novel MRI measures at 10 years 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 10 years (for sites with access to the D2201/2201E1 MRI scanner) ;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)

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients with disability progression at 10 years will be summarized -Change in MRI measures at 10 year follow up -New MRI measures (deep gey matter volume, corical thickness, T1 hypointense lesion “black hole” volume) will be measured at 10 year follow up -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 ;Timepoint(s) of evaluation of this end point: 10 year since starting study (FTY720D2201)	—

Measure

Time frame

Secondary end point(s): Proportion of patients with disability progression at 10 years will be summarized -Change in MRI measures at 10 year follow up -New MRI measures (deep gey matter volume, corical thickness, T1 hypointense lesion “black hole” volume) will be measured at 10 year follow up -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 ;Timepoint(s) of evaluation of this end point: 10 year since starting study (FTY720D2201)

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Countries

Canada, Denmark, Finland, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, United Kingdom

Contacts

Public ContactDrug Regulatory Affairs

Novartis Farma SpA

info.studiclinici@novartis.com+390296542287

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026