PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod
PROFILE
Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)
1 other identifier
observational
114
1 country
14
Brief Summary
Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
Typical duration for all trials
14 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
Study Start
First participant enrolled
November 11, 2014
CompletedFirst Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 1, 2019
March 1, 2019
2.2 years
December 2, 2014
March 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)
12 months
Secondary Outcomes (5)
MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them
12 months
Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment
12 months
Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya
12 months
Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29
12 months
Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L
12 months
Eligibility Criteria
Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod
You may qualify if:
- Patients prescribed Gilenya within the EU licence No previous exposure to Gilenya Patient's HCP considers patient able to complete study questionnaires Patient is between 18-55 years of age -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Novartis Investigative Site
Swansea, England, SA6 6NL, United Kingdom
Novartis Investigative Site
Romford, Essex, RM7 0AG, United Kingdom
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA, United Kingdom
Novartis Investigative Site
Edinburgh, EH16 4SA, United Kingdom
Novartis Investigative Site
Glasgow, G51 4TF, United Kingdom
Novartis Investigative Site
Leicester, LE5 4PW, United Kingdom
Novartis Investigative Site
Liverpool, L9 7LT, United Kingdom
Novartis Investigative Site
London, E1 1BB, United Kingdom
Novartis Investigative Site
London, SW17 0QT, United Kingdom
Novartis Investigative Site
London, W6 8RF, United Kingdom
Novartis Investigative Site
London, WC1N 3BG, United Kingdom
Novartis Investigative Site
Norwich, NR4 7UY, United Kingdom
Novartis Investigative Site
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2014
First Posted
January 12, 2015
Study Start
November 11, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 1, 2019
Record last verified: 2019-03