Relapsing Remitting Multiple Sclerosis
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline after 12 months treatment with Gilenya as measured by the MSIS-29 (physical and psychological domains) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| MSIS-29 and utility scores measured by EQ-5D-5L and any correlation between them | 12 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM) and changes at 3 , 6 and 12mths after Gilenya treatment | 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 |
| Changes from Baseline after 3, 6 and 12 months of treatment with Gilenya as measured by EQ-5D-5L | 12 months |
Countries
United Kingdom
Outcome results
None listed