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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Cohort | No Intervention | 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. | |
| Personalized Patient Counselling Cohort | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Patient Counselling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
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Inclusion Criteria:
Other Inclusion Criteria May apply.
Exclusion Criteria:
Other Exclusion Criteria May Apply.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Winnipeg | Manitoba | R3A 1M3 | Canada | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. | 52 weeks |
| Fredericton |
| New Brunswick |
| E3B 6H5 |
| Canada |
| Research Site | Quispamsis | New Brunswick | E2E 4J8 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Research Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Research Site | Kingston | Ontario | K7L 2W7 | Canada |
| Research Site | Mississauga | Ontario | L5M 2V8 | Canada |
| Research Site | Ottawa | Ontario | K1S 1C2 | Canada |
| Research Site | Peterborough | Ontario | K9J 2V4 | Canada |
| Research Site | Montreal | Quebec | H2L 1S6 | Canada |
| Research Site | Montreal | Quebec | H3T 1Y3 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Rimouski | Quebec | G5L 8W1 | Canada |
| Research Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Research Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study. | Posted | 52 weeks |
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| 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. | Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study. | Posted | 52 weeks |
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| 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. | Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study. | Posted | 52 weeks |
|
52 weeks
Only adverse drug reactions and serious adverse drug reactions were collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 19 | 1 | 19 | ||
| EG001 | 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 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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