Persistence to EnbrelPhase 4NCT02346877

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

A Phase 4 study testing Personalized Patient Counselling in people with Persistence to Enbrel, run by Amgen at 15 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Persistence to Enbrel
What is being tested?: Personalized Patient Counselling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 15 sitesCanada
Study dates: Apr 2015to Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Canada15 sites

Research Site
Fredericton, New Brunswick, E3B 6H5
Research Site
Hamilton, Ontario, L8N 1Y2
Research Site
Kingston, Ontario, K7L 2W7
Research Site
Mississauga, Ontario, L5M 2V8
Research Site
Montreal, Quebec, H2L 1S6
Research Site
Montreal, Quebec, H3T 1Y3
Research Site
Ottawa, Ontario, K1S 1C2
Research Site
Peterborough, Ontario, K9J 2V4
Research Site
Québec, Quebec, G1V 3M7
Research Site
Quispamsis, New Brunswick, E2E 4J8
Research Site
Rimouski, Quebec, G5L 8W1
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8
Research Site
Trois-Rivières, Quebec, G8Z 1Y2
Research Site
Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

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)

Conditions: Persistence to Enbrel
Being tested: Personalized Patient Counselling
Keywords: Enbrel, Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personalized Patient CounsellingBehavioural
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.

Study groups in NCT02346877
Study group	Role	What they receive
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. Receives: Behavioral: Personalized Patient Counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 52 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Oct 2015

First posted27 Jan 2015 (estimated)
Study startApr 2015
Primary completionOct 2015
Study completionOct 2015

Why it stopped: Business Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Persistence to EnbrelStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02346877
Sponsor's protocol ID: 20130340
Status last verified: Mar 2017
First submitted: 7 Jan 2015
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02346877
Acronym / sponsor ID: 20130340
Conditions: Persistence to Enbrel
Keywords: Enbrel, Rheumatoid Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Decision
Enrolment: 19 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Behavioral: Personalized Patient CounsellingInitiation 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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Personalized Patient CounsellingIn 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.	Behavioural	Personalized Patient Counselling Cohort

Primary outcome

Persistence of Study Drug Measured at 52 Weeks
Time frame: 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.

2 secondary outcomes

Adherence to Study Drug up to 52 Weeks
Time frame: 52 weeks
Beliefs About Medicines Questionnaire (BMQ)
Time frame: 52 weeks

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care (Control) Cohort	19	0
Personalized Patient Counselling (Interventional) Cohort	0	0

Primary outcome: Persistence of Study Drug Measured at 52 Weeks

Time frame: 52 weeks

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care (Control) Cohort	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Personalized Patient Counselling (Interventional) Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Personalized Patient Counselling in people with Persistence to Enbrel, run by Amgen at 15 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistence of Study Drug Measured at 52 Weeks (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02346877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.