Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults With Rheumatoid Arthritis
NCT ID: NCT02346877
Last Updated: 2017-03-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2015-04-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard of Care Cohort
The first 100 participants will be enrolled in the standard of care (control) cohort. These participants will receive treatment with Enbrel® (etanercept) in routine clinical practice and will complete a 52 week study period as per the investigator's standard of care.
No interventions assigned to this group
Personalized Patient Counselling Cohort
Initiation of the personalized patient counselling cohort will begin after 75% of participants in the control cohort have been analyzed and shown not to have high persistence. Participants will receive Enbrel® (etanercept) therapy in routine clinical practice and personalized patient counselling based on the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) baseline results through a patient assistance program for patients on Enbrel (etanercept) therapy.
Personalized Patient Counselling
In the interventional cohort participants enrolled on the study will receive personalized patient counselling using the IMS-model based on the baseline BMQ results through a patient assistance program for patients on Enbrel (Etanercept) therapy.
Interventions
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Personalized Patient Counselling
In the interventional cohort participants enrolled on the study will receive personalized patient counselling using the IMS-model based on the baseline BMQ results through a patient assistance program for patients on Enbrel (Etanercept) therapy.
Eligibility Criteria
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Inclusion Criteria
* diagnosed with rheumatoid arthritis and eligible for treatment with Enbrel® (etanercept)
* Subject has been prescribed and has access to commercial Enbrel® (etanercept) (50mg once weekly) according to the subject's health insurance
* Completion of all required safety assessments before starting treatment with Enbrel® (etanercept)
Exclusion Criteria
* Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
* refusal to consent to enroll in the Enliven program
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Winnipeg, Manitoba, Canada
Research Site
Fredericton, New Brunswick, Canada
Research Site
Quispamsis, New Brunswick, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Peterborough, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Rimouski, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20130340
Identifier Type: -
Identifier Source: org_study_id
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