Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis Clinical Trial
— ACROSSOfficial title:
Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis
| Verified date | September 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
This study aims to collect follow-up data on approximately 90% of patients who were randomized and received one dose of study drug in FTY720D2201. No study drug is given or required. Patients will be required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home is provided. Information will also be gathered on deceased patients. Assessments will be performed only once within an 8 week period and include medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), Multiple Sclerosis Functional Composite (MSFC).
| Status | Completed |
| Enrollment | 177 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Randomized in study FTY720D2201 and received at least one dose of study drug. Exclusion Criteria: |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Ottawa | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Denmark | Novartis Investigative Site | Copenhagen | |
| Denmark | Novartis Investigative Site | Glostrup | |
| France | Novartis Investigative Site | Lille | |
| France | Novartis Investigative Site | Marseille | |
| Germany | Novartis Investigative Site | Würzburg | |
| Italy | Novartis Investigative Site | Gallarate | VA |
| Italy | Novartis Investigative Site | Genova | GE |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Roma | RM |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Warszawa | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | L'Hospitalet de Llobregat | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Switzerland | Novartis Investigative Site | Basel | |
| Switzerland | Novartis Investigative Site | Zuerich | |
| United Kingdom | Novartis Investigative Site | Newcastle Upon Tyne |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Canada, Denmark, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Expanded Disability Status Scale (EDSS) at 10 year | EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. | 10 years | No |
| Secondary | Proportion of patients with disability progression at 10 years | Disability progression is defined as: 1.5-point increase from baseline in subjects with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in subjects with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in subjects with baseline EDSS score >5.0. | 10 Years | No |
| Secondary | Magnetic Resonance Imaging (MRI) | To assess various MRI parameters compared to Phase II baseline scans or as novel endpoints. | 10 Years | No |
| Secondary | Correlational analyses 1 - Duration od treatment with clinical outcomes | Correlation analyses of fingolimod treatment duration and the disability progression outcomes, such as EDSS score at Year 10, First use of an ambulatory device and First documentation of Secondary Progressive Multiple Sclerosis (SPMS), will be performed for continous and non-continuous fingolimod use. | 10 Year | No |
| Secondary | Correlational analyses 2 - MRI measures with clinical outcomes | Correlation analyses of MRI measures and clinical outcomes with the disability progression outcomes, such as EDSS score at Year 10, First use of an ambulatory device and First documentation of SPMS, will be performed for continous and non-continuous fingolimod use. | 10 Year | No |
| Secondary | Correlational analyses 3 - Cognitive measures with MRI outcomes | Correlation analyses of change from Baseline at Year 10 Paced Auditory Serial Addition Test-3 (PASAT-3) score and the protocol specified MRI measures will be performed for continous and non-continuous fingolimod use. | 10 Year | No |
| Secondary | Correlational analyses 4 - Atrophy measures comparing results with old MRI scanner at 10 years | Correlation analyses of atrophy measures at Year 10 on the same MRI scanner used for the D2201/ 2201E1 study and the same measure using the new MRI scanner will be performed for continous and non-continuous fingolimod use. | 10 Year | No |