A Phase 4 Study to Assess the Impact of Patient Support Program on Hea
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
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12 | Adjusted Mean Difference 0.48 | -8.30–9.25 | 0.9148 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Baseline and Month 12
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subject Support Program (MinSupport Plus) | 35.19 units on a scale | 24.38 (Standard Deviation) | 38 |
| Technical Support for the RebiSmart™ Device | 30.48 units on a scale | 20.94 (Standard Deviation) | 39 |
| Subject Support Program (MinSupport Plus) | -2.44 units on a scale | 19.38 (Standard Deviation) | 38 |
| Technical Support for the RebiSmart™ Device | -3.04 units on a scale | 19.76 (Standard Deviation) | 39 |
Subject Support Program (MinSupport Plus)
Technical Support for the RebiSmart™ Device
Subject Support Program (MinSupport Plus)
Technical Support for the RebiSmart™ Device
p = 0.9148; Adjusted Mean Difference 0.48 (95% CI -8.30–9.25)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Patient Support Program (MinSupport Plus) | 46 | 2 (4.3%) | |
| Technical Support for the RebiSmart™ Device | 47 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Baseline and Month 12
Quality of life (reported by participants)
Other measures (15)
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6
Baseline and Month 6
Quality of life (reported by participants)Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
Baseline, Month 6 and 12
Quality of life (reported by participants)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
Walking and mobilityPainMood and sleepQuality of life (reported by participants)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
Quality of life (reported by participants)Percentage of Subjects With Treatment Adherence at Month 6 and 12
Month 6 and 12
Quality of life (reported by participants)Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
Baseline, Month 6 and 12
FatigueMood and sleepChange From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
Baseline, Month 6 and 12
FatigueChange From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
Baseline, Month 6 and 12
FatigueChange From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Baseline, Month 6 and 12
Mood and sleepNumber of Subjects With Working Ability at Month 12
Month 12
Who could take part
Relapsing MS · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Feb 2013
Main results due
Feb 2016
Finished
Feb 2016
Results posted
Jul 2017