PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod (PROFILE)

March 28, 2019 updated by: Novartis Pharmaceuticals

Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting multiple sclerosis patients assessing the change in QoL and PRO outcome measures from baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals via post.

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Novartis Investigative Site
      • Glasgow, United Kingdom, G51 4TF
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE5 4PW
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L9 7LT
        • Novartis Investigative Site
      • London, United Kingdom, SW17 0QT
        • Novartis Investigative Site
      • London, United Kingdom, W6 8RF
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
      • London, United Kingdom, WC1N 3BG
        • Novartis Investigative Site
      • Norwich, United Kingdom, NR4 7UY
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG5 1PB
        • Novartis Investigative Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Novartis Investigative Site
    • England
      • Swansea, England, United Kingdom, SA6 6NL
        • Novartis Investigative Site
    • Essex
      • Romford, Essex, United Kingdom, RM7 0AG
        • Novartis Investigative Site
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod

Description

Inclusion Criteria:

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 -

Exclusion Criteria:

There are no exclusion criteria for this study.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them
Time Frame: 12 months
12 months
Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment
Time Frame: 12 months
12 months
Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya
Time Frame: 12 months
12 months
Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29
Time Frame: 12 months
12 months
Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720DGB04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Remitting Multiple Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe