REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

Psoriatic Arthritis Clinical Trial

Official title:

Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127842
• Other study ID #: 20040131
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2005
• Last updated: March 24, 2014
• Start date: August 2005
• Est. completion date: September 2009

Study information

• Verified date: March 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2009
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Etanercept
Administered according to the product monograph by subcutaneous (SC) injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Wyeth is now a wholly owned subsidiary of Pfizer

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 24 months	No
Secondary	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.	Baseline and 24 months	No
Secondary	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.	Baseline and Month 24	No
Secondary	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.	Baseline and month 24	No
Secondary	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.	Baseline and month 24	No
Secondary	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.	Baseline and month 24	No
Secondary	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.	Baseline and Month 24	No
Secondary	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.	Baseline and Month 24	No
Secondary	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.	Baseline and month 24	No
Secondary	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.	Baseline and Month 24	No
Secondary	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).	Baseline and Month 24	No

External Links

•   AmgenTrials clinical trials website