A Phase 4 interventional study of Personalized Patient Counselling in Persistence to Enbrel, sponsored by Amgen. Terminated at 15 sites in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Amgen · Phase 4, Interventional, and Diagnostic
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 19 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
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Other Inclusion Criteria May apply.
Exclusion Criteria:
Other Exclusion Criteria May Apply.
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.
Behavioral: Personalized 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.
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
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
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
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.
| Milestone | Standard of Care (Control) Cohort | Personalized Patient Counselling (Interventional) Cohort |
|---|---|---|
| Started | 19 | 0 |
| Completed | 0 | 0 |
| Not completed | 19 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Administrative decision | 1 | 0 |
| Withdrew: Sponsor decision | 12 | 0 |
| Withdrew: Missing | 5 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care (Control) Cohort | — | 0/19 (0%) | 1/19 (5.3%) |
| Personalized Patient Counselling (Interventional) Cohort | — | — | — |
| Event | Standard of Care (Control) Cohort | Personalized Patient Counselling (Interventional) Cohort |
|---|---|---|
| Injection site reactionInjury, poisoning and procedural complications | 1/19 | — |
| Age, Continuous(years) | Standard of Care (Control) Cohort | Personalized Patient Counselling (Interventional) Cohort | Total |
|---|---|---|---|
| Mean | 57.1 ± 10.1 | — | 57.1 ± 10.1 |
| Sex: Female, Male(Participants) | Standard of Care (Control) Cohort | Personalized Patient Counselling (Interventional) Cohort | Total |
|---|---|---|---|
| Female | 14 | — | 14 |
| Male | 5 | — | 5 |
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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