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CAMEO: Canadian Methotrexate and Etanercept Outcome Study

2014年7月14日 更新者：Amgen

Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)

The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This noninferiority study was a multicenter, open-label, randomized trial of patients with rheumatoid arthritis (RA). Patients who did not have an adequate response to methotrexate (MTX) had etanercept (50 mg/week subcutaneously [SC]) added to existing MTX therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses of MTX) at baseline and were followed for 6 months. After 6 months of therapy, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: either discontinue MTX (tapered over 6 weeks) and continue etanercept alone or continue both etanercept plus MTX for an additional 18 months.

研究の種類

介入

入学 (実際)

258

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • カナダ
      • Quebec、カナダ、G1V 3M7
        • Research Site
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 3Y1
        • Research Site
      • Victoria、British Columbia、カナダ、V8V 3P9
        • Research Site
      • Victoria、British Columbia、カナダ、V8P 5P6
        • Research Site
    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3A 1M3
        • Research Site
    • New Brunswick
      • Quispamsis、New Brunswick、カナダ、E2E 4J8
        • Research Site
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、カナダ、A1C 5B8
        • Research Site
      • St. John's、Newfoundland and Labrador、カナダ、A1A 5E8
        • Research Site
    • Nova Scotia
      • Sydney、Nova Scotia、カナダ、B1S 3N1
        • Research Site
    • Ontario
      • Bowmanville、Ontario、カナダ、L1C 1P6
        • Research Site
      • Brampton、Ontario、カナダ、L6T 3J1
        • Research Site
      • Burlington、Ontario、カナダ、L7R 4B7
        • Research Site
      • Hamilton、Ontario、カナダ、L8N 1Y2
        • Research Site
      • London、Ontario、カナダ、N6A 4V2
        • Research Site
      • Mississauga、Ontario、カナダ、L5M 2V8
        • Research Site
      • Newmarket、Ontario、カナダ、L3Y 3R7
        • Research Site
      • Ottawa、Ontario、カナダ、K1S 1C2
        • Research Site
      • St Catharines、Ontario、カナダ、L2N 7E4
        • Research Site
      • Toronto、Ontario、カナダ、M5G 1X5
        • Research Site
      • Toronto、Ontario、カナダ、M9B 6H8
        • Research Site
    • Quebec
      • Laval、Quebec、カナダ、H7T 2P5
        • Research Site
      • Montreal、Quebec、カナダ、H3T 1E2
        • Research Site
      • Montreal、Quebec、カナダ、H2L 1S6
        • Research Site
      • Montreal、Quebec、カナダ、H3Z 2Z3
        • Research Site
      • Rimouski、Quebec、カナダ、G5L 8W1
        • Research Site
      • Saint Leonard、Quebec、カナダ、H1R 1X8
        • Research Site
      • Saint-Eustache、Quebec、カナダ、J7P 4J2
        • Research Site
    • Saskatchewan
      • Saskatoon、Saskatchewan、カナダ、S7K 0H6
        • Research Site

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:

  • 18 years of age or older at the baseline visit
  • An American College of Rheumatology(ACR) diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months
  • Active disease of at least 3 swollen joints from the Disease Activity Severity 28 at the baseline visit
  • A Disease Activity Severity 28 score of ≥ 3.2 at the baseline visit
  • Have not previously received etanercept therapy
  • Able to start etanercept therapy per the approved product monograph
  • Able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 weeks and this dose has been stable at least 4 weeks before the baseline visit
  • The patient or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedures are performed

Exclusion Criteria:

  • Patients who have a positive purified protein derivative (PPD) skin test and who do not have a documented course of anti-tuberculosis therapy. Patients with a positive PPD skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. The full course of anti-tuberculosis therapy must be completed
  • Patients who have previously received infliximab or adalimumab
  • Active infections within 2 weeks of the baseline visit or during the study period
  • Any history of human immunodeficiency (HIV) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis B, hepatitis C, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years
  • Women who are pregnant or lactating or of childbearing potential who are not using adequate contraception
  • Receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period
  • 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
  • Participants not available for follow-up assessment or unable to comply with study 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：ランダム化
  • 介入モデル：並列代入
  • 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
アクティブコンパレータ：Etanercept + Methotrexate
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
生物学的：Etanercept
Commercially available etanercept administered subcutaneously at 50 mg/week.
他の名前：
  • エンブレル®
薬：Methotrexate
Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
実験的：Etanercept Only
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
生物学的：Etanercept
Commercially available etanercept administered subcutaneously at 50 mg/week.
他の名前：
  • エンブレル®
薬：Methotrexate
Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)

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
Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
時間枠：Month 6 (randomization) and Month 12
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.
Month 6 (randomization) and Month 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Disease Activity Score (DAS) 28 Response
時間枠：Month 6, 12, 18 and 24
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.
Month 6, 12, 18 and 24
Change From Baseline in Disease Activity Score 28 (DAS28)
時間枠：Baseline and Month 6, 12, 18 and 24
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.
Baseline and Month 6, 12, 18 and 24
Drug Persistence
時間枠：Month 6, 12, 18 and 24
Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.
Month 6, 12, 18 and 24
Change From Baseline in Modified Total Sharp Score (mTSS)
時間枠：Baseline, Month 12 and Month 24
The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.
Baseline, Month 12 and Month 24
Change From Baseline in Joint Erosion Score
時間枠：Baseline, Month 12 and Month 24
X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.
Baseline, Month 12 and Month 24
Change From Baseline in Joint Space Narrowing
時間枠：Baseline, Month 12 and Month 24

X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows:

0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.

End of study is Month 24 or early termination.
Baseline, Month 12 and Month 24
Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)
時間枠：Month 6, 12, 18 and 24
The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.
Month 6, 12, 18 and 24
Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)
時間枠：Month 6, 12, 18 and 24
The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.
Month 6, 12, 18 and 24
Change From Month 6 in Short Form 36 Health Survey (SF-36)
時間枠：Month 6, 12, 18 and 24

The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant.

The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.

End of study is month 24 or early termination.
Month 6, 12, 18 and 24
Change From Month 6 in Work Productivity and Activity Impairment (WPAI)
時間枠：Month 6, 12, 18 and 24
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.
Month 6, 12, 18 and 24
Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)
時間枠：Month 6, 12, 18 and 24
The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 - 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.
Month 6, 12, 18 and 24
Number of Participants With Adverse Events (AEs)
時間枠：25 months
A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
25 months

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。

スポンサー

Amgen

協力者

Wyeth is now a wholly owned subsidiary of Pfizer

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。

一般刊行物

便利なリンク

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

2008年6月1日

一次修了 (実際)

2012年12月1日

研究の完了 (実際)

2013年2月1日

試験登録日

最初に提出

2008年4月3日

QC基準を満たした最初の提出物

2008年4月7日

最初の投稿 (見積もり)

2008年4月8日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年7月23日

QC基準を満たした最後の更新が送信されました

2014年7月14日

最終確認日

2014年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 20070301

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。

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