Clinical trial NCT01791244: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Relapsing-Remitting
Keywords: Multiple Sclerosis
Relapsing-Remitting
Rebif
RebiSmart
Patient support program
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: 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
timeFrame: Baseline, Month 6 and 12
measure: Percentage of Subjects With Treatment Adherence at Month 6 and 12
timeFrame: Month 6 and 12
measure: Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
timeFrame: Baseline, Month 6 and 12
measure: Number of Subjects With Working Ability at Month 12
timeFrame: Month 12
measure: Percentage of Subjects With Adverse Events (AE) up to Month 12
timeFrame: Baseline up to Month 12
measure: Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
timeFrame: Month 6 and 12
measure: Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
timeFrame: Month 12
measure: Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
timeFrame: Month 12
measure: Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck Communications Service for Recruiting locations
city: Angered
country: Sweden
facility: Research site
city: Danderyd
country: Sweden
facility: Research Site
city: Eksjö
country: Sweden
facility: Research Site
city: Gävle
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: KS Huddinge
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Malmö/Lund
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Ängelholm
country: Sweden
facility: Research site
city: Örnsköldsvik
country: Sweden
facility: Research Site
Study officials:
References:
citation: Landtblom AM, Guala D, Martin C, Olsson-Hau S, Haghighi S, Jansson L, Fredrikson S. RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif. PLoS One. 2019 Jul 5;14(7):e0218453. doi: 10.1371/journal.pone.0218453. eCollection 2019.