このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol (SONAR-12)

2014年3月18日 更新者：UCB Pharma SA

An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol

The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).

調査の概要

状態

完了

条件

詳細な説明

An open-label, prospective, and post-authorization observational study. This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.

研究の種類

観察的

入学 (実際)

81

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

  • スペイン
      • A Coruña、スペイン
        • 11
      • Barcelona、スペイン
        • 7
      • Barcelona、スペイン
        • 15
      • Barcelona、スペイン
        • 20
      • Barcelona、スペイン
        • 4
      • Girona、スペイン
        • 21
      • Granada、スペイン
        • 9
      • Leon、スペイン
        • 12
      • Lerida、スペイン
        • 18
      • Lérida、スペイン
        • 17
      • Salamanca、スペイン
        • 6
      • Sevilla、スペイン
        • 10
      • Tarragona、スペイン
        • 14
      • Tarragona、スペイン
        • 16
      • Vigo、スペイン
        • 5

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

サンプリング方法

確率サンプル

調査対象母集団

Patients with RA who begin therapy with CZP will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the study protocol.

The study will include approximately 105 patients from 20 to 25 sites in Spain.

説明

Inclusion Criteria:

  • Patient is male or female, aged 18 years or older
  • Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
  • Patient has DAS28 (ESR) > 4.5 and CRP > 1.0 mg/dl at Baseline
  • Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
  • Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
  • Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
  • Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
  • Patient has signed and dated a written informed consent form
  • The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • Patient has a known hypersensitivity to the active substance or to any of the excipients
  • Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
  • Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
  • Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
  • Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy

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

コホートと介入

グループ/コホート
Certolizumab Pegol treatment
Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol.

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 Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
時間枠：From Baseline (Week 0) to Week 12
The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.
From Baseline (Week 0) to Week 12
Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
時間枠：From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
時間枠：From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
時間枠：From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
時間枠：From Baseline (Week 0) to Week 12
The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
From Baseline (Week 0) to Week 12
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
時間枠：From Baseline (Week 0) to Week 12
The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
From Baseline (Week 0) to Week 12
Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
時間枠：From Baseline (Week 0) to Week 12
VAS ranges from 0 (no pain) to 100 (worst pain).
From Baseline (Week 0) to Week 12
Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
時間枠：From Baseline (Week 0) to Week 12
The DAS28 is used for assessing disease activity in RA. The number of swollen and tender joints will be assessed using 28-joint counts (tender 28 and swollen 28). The ESR is measured in mm/h. In addition the Patient's General Health (GH) is obtained and recorded on a Visual Analog Scale (VAS) of 100 mm. Using this data, the DAS28 [ESR] can be calculated.
From Baseline (Week 0) to Week 12
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
時間枠：From Baseline (Week 0) to Week 12
ESR is an inflammatory parameter measured in mm/h.
From Baseline (Week 0) to Week 12
Change from Baseline in the Rheumatoid Factor (RF) at Week 12
時間枠：From Baseline (Week 0) to Week 12
RF is an inflammatory parameter measured in International Units (IU)/ml.
From Baseline (Week 0) to Week 12
Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
時間枠：From Baseline (Week 0) to Week 12
CRP is an inflammatory parameter measured in mg/l.
From Baseline (Week 0) to Week 12
Change from Baseline in the C3 level at Week 12
時間枠：From Baseline (Week 0) to Week 12
C3 is an inflammatory parameter. This measurement includes only subjects for which C3 data are available in the medical history of the subject.
From Baseline (Week 0) to Week 12
Change from Baseline in the C4 level at Week 12
時間枠：From Baseline (Week 0) to Week 12
C4 is an inflammatory parameter. This measurement includes only subjects for which C4 data are available in the medical history of the subject.
From Baseline (Week 0) to Week 12
Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
時間枠：From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
時間枠：From Week 6 to Week 12
From Week 6 to Week 12
Change from Baseline in global ultrasound index at Week 6
時間枠：From Baseline (Week 0) to Week 6
Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
From Baseline (Week 0) to Week 6
Change from Baseline in global ultrasound index at Week 12
時間枠：From Baseline (Week 0) to Week 12
Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
From Baseline (Week 0) to Week 12
Number of injection site reactions during the study (up to 16 weeks)
時間枠：From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

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

UCB Pharma SA

協力者

ReSearch Pharmaceutical Services, Inc.

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

2012年1月1日

一次修了 (実際)

2014年3月1日

研究の完了 (実際)

2014年3月1日

試験登録日

最初に提出

2012年2月1日

QC基準を満たした最初の提出物

2012年2月1日

最初の投稿 (見積もり)

2012年2月3日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年3月19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18日

最終確認日

2014年3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

  • RA0053
  • UCB-CER-2010-01

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。

購読する