Trial Outcomes & Findings for Evaluate Effects of Personalized Patient Counselling for Enbrel® Therapy in Adults With Rheumatoid Arthritis (NCT NCT02346877)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

52 weeks

Results posted on

2017-03-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	19	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	0
Overall Study Administrative Decision	1	0
Overall Study Sponsor Decision	12	0
Overall Study Missing	5	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (Control) Cohort n=19 Participants 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.	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.	Total n=19 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 10.1 • n=5 Participants	—	57.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	—	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	—	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Population: Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.

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.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care (Control) Cohort

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Personalized Patient Counselling (Interventional) Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care (Control) Cohort n=19 participants at risk 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.	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.
Injury, poisoning and procedural complications Injection site reaction	5.3% 1/19 • 52 weeks Only adverse drug reactions and serious adverse drug reactions were collected in this study.	— 0/0 • 52 weeks Only adverse drug reactions and serious adverse drug reactions were collected in this study.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER