A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device

Study Overview
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Brief Summary
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This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.

Official Title
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A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Rebif®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 or older A diagnosis of relapsing-remitting multiple sclerosis according to the revised McDonald Criteria (2010) Treatment with Rebif® 22 or 44 mcg subcutaneously three times a week in accordance to the Summary of product characteristics Rebif® administered by the RebiSmart™ device Provided a signed informed consent form Exclusion Criteria: Has received any components, except for technical support, of MinSupport Plus prior to study entry Has difficulty reading and/or understanding Swedish Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude No access to computer Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Technical support for the RebiSmart™ device<br>Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with technical support for RebiSmart. | Drug: Rebif®<br> <br> |
| Experimental: Subject support program (MinSupport Plus)<br>Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support. | Drug: Rebif®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12 | Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning. | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6 | Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning. | Baseline and Month 6 | 
| Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12 | Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The total score of the MSIS-29 was comprised of all the 29 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Score was calculated using following formula: sum of score for 29 questions - 29/1.45. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning. | Baseline, Month 6 and 12 | 
| Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12 | Quality of life was assessed using the EQ5D-5L score, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems) in which 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. A unique EQ5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from 5 to 25. An increase in the EQ5D-5L total score indicates worsening. | Baseline, Month 6 and 12 | 
| Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12 | EQ-5D-5L VAS was used to record a subject's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. | Baseline, Month 6 and 12 | 
| Percentage of Subjects With Treatment Adherence at Month 6 and 12 | According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with <10% missed injections (measured with the software RDS 2.0) during 6 and 12 months were reported. | Month 6 and 12 | 
| Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12 | Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. | Baseline, Month 6 and 12 | 
| Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12 | The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always). A total score ranged from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning. | Baseline, Month 6 and 12 | 
| Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12 | The Modified Fatigue Impact Index assesses fatigue- severity, distress, or degree of interference. Modified Fatigue Impact Scale Index was expressed in terms of percentage and ranged from 0% (no fatigue) to 100% (almost always impacted by fatigue). | Baseline, Month 6 and 12 | 
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12 | Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety in patients. The scale was limited to 14 questions, a practical tool for identifying and quantifying the two most common forms psychological disturbances in medical subjects. 7 of the items relate to anxiety and 7 relate to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression. | Baseline, Month 6 and 12 | 
| Number of Subjects With Working Ability at Month 12 | Working ability was assessed by measuring the number of subjects for the following categories: 1) Subjects with full sickness/disability pension, 2) Subjects who were employed or had their own business, 3) Subjects who were retired, 4) Subjects who were studying, 5) None of the above. | Month 12 | 
| Percentage of Subjects With Adverse Events (AE) up to Month 12 | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment Emergent Adverse Events (TEAEs) include both Serious TEAEs and non-serious TEAEs. | Baseline up to Month 12 | 
| Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12 | Lifestyle Questionnaire was used to assess the quality of life for subjects based on following parameters: Stress, Alcohol, Cost, Physical Aspect, Sleep, Activity and Smoking. Subjects provided their responses on the basis of three color codes: Green, Orange and Red, where Green refers to - no problem; Orange refers to - some problem and red refers to - definite/debilitating problem. | Month 6 and 12 | 
| Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12 | The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either Very discontented, discontented, contented or Very contented. | Month 12 | 
| Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12 | The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either Very unsatisfied, unsatisfied, satisfied or very satisfied. | Month 12 | 
| Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12 | Subjects defined up to 4 personal lifestyle goals during the first study week. Subjects completed the following questions related to lifestyle goals achieved during this study: 1. Was the goal achieved? (Yes/No) 2. If yes, better than expected or achieved as expected? 3. If better than expected, a lot or a little better than expected? 4. If no, a little or a lot less than expected? | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing-Remitting, Rebif, RebiSmart, Patient support program