Clinical trial NCT02307838: Long-term Follow-up of Fingolimod Phase II Study Patients
Official title: Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Keywords: Multiple Sclerosis, MS, RRMS, relapsing forms of multiple sclerosis, fingolimod, FTY720, Gilenya
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 177
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were 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 was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

Detailed description: This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.

Eligibility criteria: 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:

* None

Primary outcomes:
measure: Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Secondary outcomes:
measure: Number of Participants With Disability Progression
timeFrame: 10 Years
measure: Number of Participants With EDSS <4 or <6
timeFrame: 10 years
measure: Number of Participants Not Using a Wheelchair or Being Bedridden
timeFrame: 10 years
measure: Number of Participants Classified as Secondary Progressive MS (SPMS)
timeFrame: 10 years
measure: Percentage of Participants With First Use of an Ambulatory Device
timeFrame: 10 years
measure: Percentage of Participants With First Use of a Wheelchair
timeFrame: 10 years
measure: Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
timeFrame: baseline from core study, CFTY720D2201 (NCT00333138), 10 years
measure: Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Total Volume in T2 Lesion
timeFrame: 10 years
measure: Change From Baseline in Total Volume of T2 Lesion
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Third Ventricle Diameter
timeFrame: 10 years
measure: Change From Baseline in Third Ventricle Diameter
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Percentage Brain Volume Change (PBVC)
timeFrame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
measure: Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters
timeFrame: 10 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Glostrup
country: Denmark
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Gallarate
country: Italy
facility: Novartis Investigative Site
state: VA
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: L'Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: