REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
2014年3月24日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
110
段階
- フェーズ 4
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
|
Administered according to the product monograph by subcutaneous (SC) injection
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年8月1日
一次修了 (実際)
2005年8月1日
研究の完了 (実際)
2009年9月1日
試験登録日
最初に提出
2005年8月5日
QC基準を満たした最初の提出物
2005年8月5日
最初の投稿 (見積もり)
2005年8月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年4月24日
QC基準を満たした最後の更新が送信されました
2014年3月24日
最終確認日
2014年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Etanerceptの臨床試験
-
All India Institute of Medical Sciences, New Delhi完了