Phase 4
Completed N=93
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
Multiple Sclerosis · Relapsing-Remitting
Source: ClinicalTrials.gov NCT01791244 ↗
Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Jul 2017
Primary outcomePrimary: Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12 — 35.19; 30.48; -2.44; -3.04 units on a scale — p=0.9148
◆ Published Evidence
Emerging
12citations · ~2 / year
RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif.
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.
Linked Publications
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RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12 |
35.19; 30.48; -2.44; -3.04 | 0.9148 |
| SECONDARY Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6 |
35.19; 30.48; -1.36; -1.59 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12 |
21.81; 18.01; 0.56; 0.14; 1.00; 0.00 | — |
| SECONDARY Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12 |
8.84; 8.03; 0.18; 0.10; 0.05; -0.08 | — |
| SECONDARY 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 |
71.18; 71.49; -0.71; -3.38; -0.84; -2.31 | — |
| SECONDARY Percentage of Subjects With Treatment Adherence at Month 6 and 12 |
71.05; 64.10; 65.79; 53.85 | — |
| SECONDARY Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12 |
3.93; 3.98; 0.15; 0.05; 0.13; 0.08 | — |
| SECONDARY Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12 |
29.74; 31.08; 3.89; 2.27; 3.75; 1.78 | — |
| SECONDARY Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12 |
35.40; 37.00; 4.63; 2.71; 4.47; 2.12 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12 |
6.13; 5.62; -0.21; -0.56; -0.42; -0.18 | — |
| SECONDARY Number of Subjects With Working Ability at Month 12 |
4; 5; 22; 25; 2; 2 | — |
| SECONDARY Percentage of Subjects With Adverse Events (AE) up to Month 12 |
45.7; 61.7 | — |
| SECONDARY Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12 |
2; 3; 3; 3; 2; 2 | — |
| SECONDARY Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12 |
1; 2; 6; 5; 13; 11 | — |
| SECONDARY Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12 |
0; 1; 2; 0; 10; 9 | — |
| SECONDARY Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12 |
18; 4; 16; 5; 10; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01791244) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.