Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With RRMS

Study Overview
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Brief Summary
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A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in RRMS patients to assess the impact of an individualized patient support program (PSP) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.

Official Title
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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-treated Patients With Relapsing-remitting Multiple Sclerosis

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Other: individualized patient support program
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for inclusion in this trial have to fulfill all of the following criteria: Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed. Male or female subjects aged 18 - 65 years. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5. Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1). Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: Patients, who are registered in any patient support program (e.g. Extracare) Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum) Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details). Simultaneous participation in another clinical trial. Patients, who have already been randomized into this trial earlier must not be included a second time. Study personnel or first degree relatives of investigator(s) must not be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 standard care<br>standard care | Other: Standard care<br> <br> |
| Experimental: 2 individualized PSP<br>individualized patient support program | Other: individualized patient support program<br>* individualized patient support with compliance supporting tools<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in treatment satisfaction (TSQM-9) from baseline to month 6 | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Modified Morisky Scale score from baseline to month 6 | 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. | 6 months | 
| quantification of therapy adherence (pill-count) 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. | 6 months | 
| change in mFIS score from baseline to month 6 | 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. | 6 months | 
| change in BDI from baseline to month 6 | 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. | 6 months |