此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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).

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

81

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：From Week 6 to Week 12
From Week 6 to Week 12
Change from Baseline in global ultrasound index at Week 6
大体时间：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
大体时间：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)
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Pharma SA

合作者

ReSearch Pharmaceutical Services, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2012年2月1日

首先提交符合 QC 标准的

2012年2月1日

首次发布 (估计)

2012年2月3日

研究记录更新

最后更新发布 (估计)

2014年3月19日

上次提交的符合 QC 标准的更新

2014年3月18日

最后验证

2014年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RA0053
  • UCB-CER-2010-01

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅