Status:
COMPLETED
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
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Relapsing-Remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01791244
Start Date
February 28 2013
End Date
February 29 2016
Last Update
August 24 2017
Active Locations (14)
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1
Please contact the Merck Communications Service for Recruiting locations
Darmstadt, Germany
2
Research site
Angered, Sweden
3
Research site
Ängelholm, Sweden
4
Research Site
Danderyd, Sweden