A Multicenter, Historical Control Study to Evaluate the Effects of Personalized Patient Counselling on Persistence to Enbrel® Therapy in Subjects With Rheumatoid Arthritis (PerSuit)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Amgen
- Enrollment
- 19
- Locations
- 16
- Primary Endpoint
- Persistence of Study Drug Measured at 52 Weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Persistence of Study Drug Measured at 52 Weeks
Time Frame: 52 weeks
A participant is persistent if the date of the last prescription filled plus the number of weeks supply of the prescription is greater than or equal to 52 weeks from enrolment and the eDiary confirms Enbrel® from the prescription was injected. A participant is not persistent if the last prescription filled plus the number of weeks supply of the prescription is less than 52 weeks from enrolment and the eDiary confirms there was no injection of Enbrel®, or, a participant is not persistent if the participant has a gap in treatment of more than 4 consecutive weeks for no medical reason at any time in the 52 week study period.
Secondary Outcomes
- Adherence to Study Drug up to 52 Weeks(52 weeks)
- Beliefs About Medicines Questionnaire (BMQ)(52 weeks)