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

Primary Purpose

Persistence to Enbrel

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Personalized Patient Counselling
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistence to Enbrel focused on measuring Enbrel, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard of Care Cohort

Personalized Patient Counselling Cohort

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Persistence of Study Drug Measured at 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 Outcome Measures

Adherence to Study Drug up to 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.
Beliefs About Medicines Questionnaire (BMQ)
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.

Full Information

First Posted
January 7, 2015
Last Updated
March 23, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02346877
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistence to Enbrel
Keywords
Enbrel, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Cohort
Arm Type
No Intervention
Arm Description
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.
Arm Title
Personalized Patient Counselling Cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Patient Counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Persistence of Study Drug Measured at 52 Weeks
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Adherence to Study Drug up to 52 Weeks
Description
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.
Time Frame
52 weeks
Title
Beliefs About Medicines Questionnaire (BMQ)
Description
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.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Research Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 6H5
Country
Canada
Facility Name
Research Site
City
Quispamsis
State/Province
New Brunswick
ZIP/Postal Code
E2E 4J8
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2W7
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 1C2
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 2V4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1Y3
Country
Canada
Facility Name
Research Site
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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