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
Overview
- Phase
- Phase 4
- Intervention
- Rebif®
- Conditions
- Multiple Sclerosis
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 93
- Locations
- 3
- Primary Endpoint
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Technical support for the RebiSmart™ device
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.
Intervention: Rebif®
Subject support program (MinSupport Plus)
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.
Intervention: Rebif®
Outcomes
Primary Outcomes
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Time Frame: Baseline and 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.
Secondary Outcomes
- Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12(Baseline, Month 6 and 12)
- Number of Subjects With Working Ability at Month 12(Month 12)
- Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12(Month 6 and 12)
- Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12(Month 12)
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6(Baseline and Month 6)
- 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(Baseline, Month 6 and 12)
- Percentage of Subjects With Treatment Adherence at Month 6 and 12(Month 6 and 12)
- Percentage of Subjects With Adverse Events (AE) up to Month 12(Baseline up to Month 12)
- Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12(Month 12)
- Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12(Month 12)
- Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12(Baseline, Month 6 and 12)