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

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2013-002660-17-DK
• Date of registration: 16/04/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis
• Scientific title: Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS
• Date of first enrolment: 02/06/2015
• Target sample size: 281
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002660-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

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

Contacts

• Name: Klinisk forskningsafdeling
• Affiliation: Novartis Healthcare A/S

• Name: Klinisk forskningsafdeling
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion 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:
Patients not meeting the inclusion criteria are excluded.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

multiple sclerosis
MedDRA version: 18.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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 descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)

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)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 10 year since starting study (FTY720D2201)

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

Secondary ID(s)

CFTY720D2201E2

2013-002660-17-IT

Source(s) of Monetary Support

Novartis Pharma Services AG