A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis

INTERVENTION: Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Pharmaceutical Form: Capsule, hard CAS Number: 162359‐56‐0 Current Sponsor code: FTY720 Other descriptive name: Fingolimod Hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ CONDITION: Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] Treatment statisfaction in patients with relapsing remitting Multiple Sclerosis ; MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders PRIMARY OUTCOME: Main Objective: To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM‐9) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. Primary end point(s): To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM‐9) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. Secondary Objective: To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months.; To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill‐count in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months.; To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months.; To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months.; Timepoint(s) of evaluation of this end point: after 6 month SECONDARY OUTCOME: Secondary end point(s): To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. ; To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill‐count in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. ; To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. ; To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod‐treated patients with relapsing‐remitting multiple sclerosis over 6 months. ; Timepoint(s) of evaluation of this end point: after 6 month INCLUSION CRITERIA: 1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. 2. Male or female subjects aged 18 – 65 years. 3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria. 4. Patients with Expanded Disability Status Scale (EDSS) score of 0‐6.5. 5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range