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
NCT ID: NCT01791244
Last Updated: 2017-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2013-02-28
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Technical support for the RebiSmart™ device
Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with technical support for RebiSmart.
Rebif®
Subject support program (MinSupport Plus)
Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject 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.
Rebif®
Interventions
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Rebif®
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Locations
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Please contact the Merck Communications Service for Recruiting locations
Darmstadt, , Germany
Research site
Angered, , Sweden
Research site
Ängelholm, , 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, , Sweden
Countries
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References
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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.
Other Identifiers
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2012-004887-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 200136-560
Identifier Type: -
Identifier Source: org_study_id
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