Clinical trial NCT02346877: Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults With Rheumatoid Arthritis
Official title: A Multicenter, Historical Control Study to Evaluate the Effects of Personalized Patient Counselling on Persistence to Enbrel® Therapy in Subjects With Rheumatoid Arthritis (PerSuit)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Persistence to Enbrel
Keywords: Enbrel
Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Persistence of Study Drug Measured at 52 Weeks
timeFrame: 52 weeks
Secondary outcomes:
measure: Adherence to Study Drug up to 52 Weeks
timeFrame: 52 weeks
measure: Beliefs About Medicines Questionnaire (BMQ)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Fredericton
country: Canada
facility: Research Site
state: New Brunswick
city: Quispamsis
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Rimouski
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: