Long-term Follow-up of Fingolimod Phase II Study Patients
ACROSS
Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)
1 other identifier
interventional
177
10 countries
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2014
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
March 23, 2017
CompletedMarch 23, 2017
February 1, 2017
1.5 years
May 14, 2014
November 28, 2016
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
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 (score) 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. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Secondary Outcomes (16)
Number of Participants With Disability Progression
10 Years
Number of Participants With EDSS <4 or <6
10 years
Number of Participants Not Using a Wheelchair or Being Bedridden
10 years
Number of Participants Classified as Secondary Progressive MS (SPMS)
10 years
Percentage of Participants With First Use of an Ambulatory Device
10 years
- +11 more secondary outcomes
Study Arms (1)
Phase 2 CFTY720D2201 (NCT02307838) participants
OTHERCFTY720D2201E2 participants did not receive any protocol specified treatment. The original D2201 study sites, who agreed to participate in this study, were required to locate their participants who were randomized in D2201 and asked them to return for a 10 year assessment, regardless of current treatment status.
Interventions
Protocol required assessments not provided in standard of care
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment is performed.
- Randomized in study FTY720D2201 and received at least one dose of study drug.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
Toronto, Ontario, M5B 1N9, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Novartis Investigative Site
Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site
Copenhagen, DK-2100, Denmark
Novartis Investigative Site
Glostrup Municipality, DK-2600, Denmark
Novartis Investigative Site
Marseille, France, 13385, France
Novartis Investigative Site
Lille, 59037, France
Novartis Investigative Site
Würzburg, 97080, Germany
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Milan, MI, 20132, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
Gallarate, VA, 21013, Italy
Novartis Investigative Site
Warsaw, 02-097, Poland
Novartis Investigative Site
Warsaw, 02-957, Poland
Novartis Investigative Site
Coimbra, Portugal, 3000-075, Portugal
Novartis Investigative Site
Lisbon, Portugal, 1150-314, Portugal
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Novartis Investigative Site
Madrid, Madrid, 28040, Spain
Novartis Investigative Site
Valencia, Valencia, 46026, Spain
Novartis Investigative Site
Basel, 4031, Switzerland
Novartis Investigative Site
Zurich, 8091, Switzerland
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
December 4, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 23, 2017
Results First Posted
March 23, 2017
Record last verified: 2017-02