Persistence to Enbrel
Conditions
Keywords
Enbrel, Rheumatoid Arthritis
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.
Interventions
BEHAVIORALPersonalized Patient Counselling
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.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of Study Drug Measured at 52 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Study Drug up to 52 Weeks | 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) | 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. |
Countries
Canada
Participant flow
Recruitment details
This study was initiated at 15 centers in Canada, of which 8 centers enrolled participants. The first participant was enrolled on 14 April 2015 and the last participant enrolled on 13 October 2015.
Pre-assignment details
Eligible participants were to be enrolled in the standard of care (control) cohort and complete the 52-week study period. Data from 75% of the group were to be analyzed before enrolling participants in the interventional cohort. As the study was prematurely closed due to slow enrollment, the interventional cohort was not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (Control) Cohort The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care. | 19 |
| Personalized Patient Counselling (Interventional) Cohort Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy. | 0 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Decision | 1 | 0 |
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Missing | 5 | 0 |
| Overall Study | Sponsor Decision | 12 | 0 |
Baseline characteristics
| Characteristic | Standard of Care (Control) Cohort | Total |
|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 10.1 | 57.1 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 0 / 0 |
| serious Total, serious adverse events | 0 / 19 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 52 weeks
Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.
Secondary
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.
Time frame: 52 weeks
Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.
Secondary
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.
Time frame: 52 weeks
Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.