PsoriasisPhase 4NCT00332332

Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis

A Phase 4 study testing etanercept in people with Psoriasis, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: etanercept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: No sites listed yet
Study dates: Mar 2006to Feb 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older at baseline
Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
Able to start Enbrel (Etanercept) therapy per the approved product monograph

Who cannot join

Active infections at the initiation of Enbrel therapy.
Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.
Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.

About this study

Official title: Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis

The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.

Conditions: Psoriasis
Being tested: etanercept
Keywords: Phase IV, Psoriasis, Inflammation
Medical subject headings: Psoriasis, Inflammation

What participants receive

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

etanerceptBiological
Also called ENBREL
etanercept subcutaneous injection

Study groups in NCT00332332
Study group	Role	What they receive
etanercept	Experimental	Open label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months. Receives: Biological: etanercept

What is being measured

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

Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.
Measured: Month 12

Secondary outcomes (3)

Percent Change From Baseline to Month 12 in Patient Global Assessment
Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline and Month 12
Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis
Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.
Measured: Baseline and Month 12
Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score
Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.
Measured: Baseline and Month 12

Timeline

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

Mar 2006Feb 2010

First posted1 Jun 2006 (estimated)
Study startMar 2006
Primary completionJul 2009
Study completionFeb 2010

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00332332
Sponsor's protocol ID: 20050180
Status last verified: Jul 2014
First submitted: 30 May 2006
Last updated: 25 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population. J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38. doi: 10.2310/7750.2012.12036.
PubMed 23582167
Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. Etanercept improves quality of life outcomes and treatment satisfaction in patients with moderate to severe plaque psoriasis in clinical practice. J Cutan Med Surg. 2012 Nov-Dec;16(6):407-16. doi: 10.1177/120347541201600609.
PubMed 23149196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis
ClinicalTrials.gov ID: NCT00332332
Acronym / sponsor ID: 20050180
Conditions: Psoriasis
Keywords: Phase IV, Psoriasis, Inflammation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer
Study start: Mar 2006
Primary completion: Jul 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 1 Jun 2006 (estimated)
Results: Posted 14 Jun 2011

Clinical summary

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

The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
etanercept	Experimental	Biological: etanerceptOpen label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months.

Who may qualify

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

Key inclusion criteria (3 listed)

18 years of age or older at baseline
Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
Able to start Enbrel (Etanercept) therapy per the approved product monograph

Key exclusion criteria (6 listed)

Active infections at the initiation of Enbrel therapy.
Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.

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
etanerceptAlso: ENBRELetanercept subcutaneous injection	Biological	etanercept

Primary outcome

Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
Time frame: Month 12
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.

3 secondary outcomes

Percent Change From Baseline to Month 12 in Patient Global Assessment
Time frame: Baseline and Month 12
Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis
Time frame: Baseline and Month 12
Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score
Time frame: Baseline and Month 12

Results and safety

Results posted to the registry on 14 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etanercept	246	178

Primary outcome: Participants With a Status of Mild or Better on Physician Global Assessment at Month 12

Time frame: Month 12. Number. Unit: Participants

Measure	Etanercept n = 226
Value	166

Etanercept: Percentage of participants: 73.5 (95% CI 67.2 to 79.1)

Population analysed: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 13 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	12 of 230 (5.2%)	59 of 230 (25.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23582167Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population. J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38. doi: 10.2310/7750.2012.12036.
Background: PubMed 23149196Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. Etanercept improves quality of life outcomes and treatment satisfaction in patients with moderate to severe plaque psoriasis in clinical practice. J Cutan Med Surg. 2012 Nov-Dec;16(6):407-16. doi: 10.1177/120347541201600609.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing etanercept in people with Psoriasis, run by Amgen.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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 14 Jun 2011). 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?

Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 (time frame: Month 12). 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 NCT00332332, which also lists 2 linked publications.

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 25 Jul 2014.