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

March 23, 2017 updated by: Amgen

A Multicenter, Historical Control Study to Evaluate the Effects of Personalized Patient Counselling on Persistence to Enbrel® Therapy in Subjects With Rheumatoid Arthritis (PerSuit)

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 Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 3M7
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 6H5
        • Research Site
      • Quispamsis, New Brunswick, Canada, E2E 4J8
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Research Site
      • Kingston, Ontario, Canada, K7L 2W7
        • Research Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • Research Site
      • Ottawa, Ontario, Canada, K1S 1C2
        • Research Site
      • Peterborough, Ontario, Canada, K9J 2V4
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
        • Research Site
      • Montreal, Quebec, Canada, H3T 1Y3
        • Research Site
      • Rimouski, Quebec, Canada, G5L 8W1
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Study Drug up to 52 Weeks
Time Frame: 52 weeks
A participant's adherence is determined as a medication possession ratio (MPR) of at least 80%. The MPR is the ratio of the total number of weeks' supply, based on pharmacy data, of Enbrel® divided by either 52 weeks or duration on study if a physician stops prescribing Enbrel® due to an adverse drug reaction or lack of efficacy.
52 weeks
Beliefs About Medicines Questionnaire (BMQ)
Time Frame: 52 weeks
BMQ consists of two five-item scales assessing patients' beliefs about the necessity of Enbrel® for controlling their rheumatoid arthritis and their concerns about potential adverse consequences of taking Enbrel®. Using a five-point Likert scale, on each of necessity and concerns, the individual items within both scales are summed. The total scores for the Necessity and Concerns Scales range from 5 to 25. Higher scores indicate stronger beliefs.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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