Psoriatic ArthritisPhase 4NCT00127842
REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
A Phase 4 study testing Etanercept in people with Psoriatic Arthritis, run by Amgen.
Trial summary
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- 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
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Sep 2009
- 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
- Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
- At least one of the following forms of psoriatic arthritis (PsA):
- Distal interphalangeal (DIP) involvement (inflammatory)
- Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
- Arthritis mutilans
- Asymmetric peripheral arthritis or
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- Spinal involvement
- Active psoriatic arthritis at the time of the study enrollment
- Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
- Greater than 18 years of age at the time of consent
- Able to start etanercept therapy per the approved product monograph
- Informed consent must be provided before any study specific procedures are performed
Who cannot join
- Active infections at time of initiating Enbrel® therapy
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
- A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
- Known hypersensitivity to etanercept or any of its components
- Patients receiving, or who have received:
- Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or
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- Kineret® (anakinra) in the previous 15 days
- Patients receiving or who have received etanercept
- Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
- Active guttate, erythrodermic or pustular psoriasis at the time of screening
- Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
- Sepsis or at risk of septic syndrome
- Patients not available for follow-up assessment
- Concerns for subject's compliance with the protocol procedures
About this study
Official title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
- Conditions
- Psoriatic Arthritis
- Being tested
- Etanercept
- Keywords
- Psoriatic Arthritis, PsA, Commercial product, American College of Rheumatology, ACR/PASI
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel®
Administered according to the product monograph by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Other | Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
Measured: Baseline and 24 months
Secondary outcomes (10)
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Measured: Baseline and 24 months
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks.
Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Measured: Baseline and Month 24
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Measured: Baseline and month 24
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
Measured: Baseline and month 24
Change From Baseline to Month 24 in the Physician Global Assessment
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
Measured: Baseline and month 24
Percent Change From Baseline to Month 24 in Physician Global Assessment
The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).
Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.
Measured: Baseline and Month 24
Change From Baseline to Month 24 in Patient Global Assessment
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
Measured: Baseline and Month 24
Percent Change From Baseline to Month 24 in Patient Global Assessment
The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.
Measured: Baseline and month 24
Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)
The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.
Measured: Baseline and Month 24
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).
Measured: Baseline and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2005
- Study completionSep 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127842
- Sponsor's protocol ID
- 20040131
- Status last verified
- Mar 2014
- First submitted
- 5 Aug 2005
- Last updated
- 24 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15.
PubMed 21572156
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
- ClinicalTrials.gov ID
- NCT00127842
- Acronym / sponsor ID
- 20040131
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, PsA, Commercial product, American College of Rheumatology, ACR/PASI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Aug 2005 (estimated)
- Results
- Posted 24 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Other | Drug: EtanerceptOpen-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
- At least one of the following forms of psoriatic arthritis (PsA):
- Active psoriatic arthritis at the time of the study enrollment
- Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
- Greater than 18 years of age at the time of consent
Key exclusion criteria (14 listed)
- Active infections at time of initiating Enbrel® therapy
- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
- A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
- Known hypersensitivity to etanercept or any of its components
- Patients receiving, or who have received:
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: Enbrel®Administered according to the product monograph by subcutaneous (SC) injection | Drug | Etanercept |
Primary outcome
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
Time frame: Baseline and 24 months
The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
10 secondary outcomes
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
Time frame: Baseline and 24 months
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
Time frame: Baseline and Month 24
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
Time frame: Baseline and month 24
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
Time frame: Baseline and month 24
Change From Baseline to Month 24 in the Physician Global Assessment
Time frame: Baseline and month 24
Percent Change From Baseline to Month 24 in Physician Global Assessment
Time frame: Baseline and Month 24
Change From Baseline to Month 24 in Patient Global Assessment
Time frame: Baseline and Month 24
Percent Change From Baseline to Month 24 in Patient Global Assessment
Time frame: Baseline and month 24
Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)
Time frame: Baseline and Month 24
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
Time frame: Baseline and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21572156Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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 Psoriatic Arthritis, 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 12 inclusion and 14 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 24 Apr 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 24 Apr 2014). 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?
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI (time frame: Baseline and 24 months). 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 NCT00127842, which also lists 1 linked publication.
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 24 Apr 2014.