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NCT02335892 Clinical Trial

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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— PROFILE  

Official title:
Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02335892
Other study ID # CFTY720DGB04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2014
Est. completion date February 1, 2017

Study information
Verified date March 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date February 1, 2017
Est. primary completion date February 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing Remitting Multiple Sclerosis

Locations
Country Name City State
United Kingdom Novartis Investigative Site Basingstoke Hampshire
United Kingdom Novartis Investigative Site Edinburgh
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site Leicester
United Kingdom Novartis Investigative Site Liverpool
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Norwich
United Kingdom Novartis Investigative Site Nottingham
United Kingdom Novartis Investigative Site Romford Essex
United Kingdom Novartis Investigative Site Swansea England
United Kingdom Novartis Investigative Site Truro Cornwall

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains) 12 months
Secondary MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them 12 months
Secondary Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment 12 months
Secondary Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya 12 months
Secondary Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29 12 months
Secondary Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L 12 months
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