Clinical trial NCT02335892: PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod
Official title: Patient Reported Outcomes With Fingolimod in Local Experience (PROFILE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-01-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod

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.

Eligibility criteria: 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.

-

Primary outcomes:
measure: Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains)
timeFrame: 12 months
Secondary outcomes:
measure: MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them
timeFrame: 12 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment
timeFrame: 12 months
measure: Morisky questionnaire and changes at 3 , 6 and 12 mths after treament with Gilenya
timeFrame: 12 months
measure: Changes from baseline after 3 and 6 months treatment with Gilenya as measured by MSIS-29
timeFrame: 12 months
measure: Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L
timeFrame: 12 months
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Swansea
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Romford
country: United Kingdom
facility: Novartis Investigative Site
state: Essex
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Norwich
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: