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

2014년 3월 24일 업데이트: Amgen

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

110

단계

  • 4단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
의약품: Etanercept
Administered according to the product monograph by subcutaneous (SC) injection
다른 이름들:
  • 엔브렐®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
기간: 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.
Baseline and 24 months

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
기간: Baseline and 24 months
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
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
기간: Baseline and Month 24

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
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
기간: Baseline and month 24
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
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
기간: Baseline and month 24
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
Change From Baseline to Month 24 in the Physician Global Assessment
기간: Baseline and month 24
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
Percent Change From Baseline to Month 24 in Physician Global Assessment
기간: Baseline and Month 24

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
Change From Baseline to Month 24 in Patient Global Assessment
기간: Baseline and Month 24
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
Percent Change From Baseline to Month 24 in Patient Global Assessment
기간: Baseline and month 24
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
Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)
기간: Baseline and Month 24
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
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
기간: Baseline and 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Amgen

협력자

Wyeth is now a wholly owned subsidiary of Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 8월 1일

기본 완료 (실제)

2005년 8월 1일

연구 완료 (실제)

2009년 9월 1일

연구 등록 날짜

최초 제출

2005년 8월 5일

QC 기준을 충족하는 최초 제출

2005년 8월 5일

처음 게시됨 (추정)

2005년 8월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 4월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 3월 24일

마지막으로 확인됨

2014년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20040131

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Etanercept에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다