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Terminated/Withdrawn
Sponsor ID
20130340

Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults with Rheumatoid Arthritis

Sponsor ID
20130340
Clinicaltrials.gov ID
NCT02346877
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This study will evaluate whether the effect of personalized patient counselling tool, Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in subjects with rheumatoid arthritis over the historical control as estimated by the standard of care.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
19
Additional Study Details

Protocol Summary

Primary Outcome Measures

Persistence of study drug measured at 52 weeks

Timeframe: 52 weeks

Secondary Outcome Measures

Adherence to study drug up to 52 weeks

Timeframe: 52 weeks

Beliefs about Medicines Questionnaire (BMQ)

Timeframe: 52 weeks

Locations

Location
Status
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Location
Research Site
Hamilton, ON, Canada, L8N 1Y2
Status
Recruiting
Location
Research Site
Fredericton, NB, Canada, E3B 6H5
Status
Recruiting
Location
Research Site
Montreal, QC, Canada, H3T 1Y3
Status
Recruiting
Location
Research Site
Peterborough, ON, Canada, K9J 2V4
Status
Completed
Location
Research Site
Quebec, QC, Canada, G1V 3M7
Status
Recruiting
Location
Research Site
Quispamsis, NB, Canada, E2E 4J8
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • General - Other
    • Sex
    All
    Trial Dates
    Apr 2015 - Oct 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Subject has provided informed consent prior to any study specific procedures • 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) Other Inclusion Criteria May apply.
    Exclusion Criteria:
    • previously received treatment with a biologic disease modifying antirheumatic drug (DMARD) and/or Tofacitinib. • 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) Other Exclusion Criteria May Apply.