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

Novartis Pharmaceuticals114 enrolled

Overview

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.

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

114

Conditions

Relapsing Remitting Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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. \-

Locations (14)

Novartis Investigative Site

Truro, Cornwall, United Kingdom

Novartis Investigative Site

Swansea, England, United Kingdom

Novartis Investigative Site

Romford, Essex, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them

Time frame: 12 months

Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment

Time frame: 12 months

Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya

Time frame: 12 months

Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29

Time frame: 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

Data from ClinicalTrials.gov

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