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

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT02335892
• Lead Sponsor: Novartis Pharmaceuticals

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.

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 Timeline

• Study Start: 2014-11-11
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Nottingham, United Kingdom