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 Clinical Trial

— RebiQoL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791244
• Other study ID #: EMR 200136-560
• Secondary ID: 2012-004887-22
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2013
• Last updated: May 2, 2016
• Start date: February 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting
• Sclerosis

Intervention

Other:
• Technical support for the RebiSmart™ device
Rebif® will be administered by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) three times a week in accordance to the summary of product characteristics. Subjects will receive only technical support for the RebiSmart™ device.
• Patient support program (MinSupport Plus)
Rebif® will be administered by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) three times a week in accordance to the summary of product characteristics. Subjects will receive 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.

Locations

Country	Name	City	State
Germany	Please contact the Merck Communications Service for Recruiting locations	Darmstadt
Sweden	Research site	Ängelholm
Sweden	Research site	Angered
Sweden	Research Site	Danderyd
Sweden	Research Site	Eksjö
Sweden	Research Site	Gävle
Sweden	Research Site	Karlstad
Sweden	Research Site	KS Huddinge
Sweden	Research Site	Linköping
Sweden	Research Site	Malmö/Lund
Sweden	Research Site	Motala
Sweden	Research Site	Örnsköldsvik
Sweden	Research Site	Skövde
Sweden	Research Site	Trollhättan

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 12		Baseline and Month 12	No
Secondary	Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 6		Baseline and Month 6	No
Secondary	Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) total score at Month 6 and 12		Baseline, Month 6 and 12	No
Secondary	Change from Baseline in Euro Quality of Life Questionnaire with 5 questions alternatives (EQ5D-5L) score at Month 6 and 12		Baseline, Month 6 and 12	No
Secondary	Percentage of subjects with treatment adherence		Month 6 and 12	No
Secondary	Change from Baseline in Fatigue Severity Scale score and Modified Fatigue Impact Scale score at Month 6 and 12		Baseline, Month 6 and 12	No
Secondary	Change from Baseline in Hospital Anxiety and Depression Scale score at Month 6 and 12		Baseline, Month 6 and 12	No
Secondary	Change from Baseline in Working ability per subject at Month 12		Baseline and Month 12	No
Secondary	Percentage of subjects with Adverse events		Month 12	Yes
Secondary	Number of subjects with categorical score on subject satisfaction questionnaire		Month 12	No
Secondary	Number of health care personnel with categorical score on Health Care Personnel satisfaction questionnaire		Month 12	No
Secondary	Change from Baseline in Lifestyle questionnaire score in subjects receiving Min Support Plus at Month 6 and 12		Baseline, Month 6 and 12	No
Secondary	Number of subjects with Lifestyle goals score in subjects receiving Min Support Plus		Baseline and Month 12	No
Secondary	Health economy as assessed by Quality of life questionnaire		Month 12	No