Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol (SONAR-12)
2014년 3월 18일 업데이트: 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).
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
관찰
등록 (실제)
81
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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A Coruña, 스페인
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Barcelona, 스페인
- 7
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Barcelona, 스페인
- 15
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Barcelona, 스페인
- 20
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Barcelona, 스페인
- 4
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Girona, 스페인
- 21
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Granada, 스페인
- 9
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Leon, 스페인
- 12
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Lerida, 스페인
- 18
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Lérida, 스페인
- 17
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Salamanca, 스페인
- 6
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Sevilla, 스페인
- 10
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Tarragona, 스페인
- 14
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Tarragona, 스페인
- 16
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Vigo, 스페인
- 5
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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
샘플링 방법
확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
기간: From Baseline (Week 0) to Week 12
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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.
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From Baseline (Week 0) to Week 12
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Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
기간: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
기간: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
기간: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
기간: From Baseline (Week 0) to Week 12
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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).
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From Baseline (Week 0) to Week 12
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Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
기간: From Baseline (Week 0) to Week 12
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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).
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From Baseline (Week 0) to Week 12
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Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
기간: From Baseline (Week 0) to Week 12
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VAS ranges from 0 (no pain) to 100 (worst pain).
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From Baseline (Week 0) to Week 12
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Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
기간: From Baseline (Week 0) to Week 12
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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.
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From Baseline (Week 0) to Week 12
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Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
기간: From Baseline (Week 0) to Week 12
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ESR is an inflammatory parameter measured in mm/h.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the Rheumatoid Factor (RF) at Week 12
기간: From Baseline (Week 0) to Week 12
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RF is an inflammatory parameter measured in International Units (IU)/ml.
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From Baseline (Week 0) to Week 12
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Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
기간: From Baseline (Week 0) to Week 12
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CRP is an inflammatory parameter measured in mg/l.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the C3 level at Week 12
기간: From Baseline (Week 0) to Week 12
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C3 is an inflammatory parameter.
This measurement includes only subjects for which C3 data are available in the medical history of the subject.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the C4 level at Week 12
기간: From Baseline (Week 0) to Week 12
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C4 is an inflammatory parameter.
This measurement includes only subjects for which C4 data are available in the medical history of the subject.
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From Baseline (Week 0) to Week 12
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Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
기간: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
기간: From Week 6 to Week 12
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From Week 6 to Week 12
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Change from Baseline in global ultrasound index at Week 6
기간: From Baseline (Week 0) to Week 6
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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.
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From Baseline (Week 0) to Week 6
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Change from Baseline in global ultrasound index at Week 12
기간: From Baseline (Week 0) to Week 12
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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.
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From Baseline (Week 0) to Week 12
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Number of injection site reactions during the study (up to 16 weeks)
기간: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2012년 1월 1일
기본 완료 (실제)
2014년 3월 1일
연구 완료 (실제)
2014년 3월 1일
연구 등록 날짜
최초 제출
2012년 2월 1일
QC 기준을 충족하는 최초 제출
2012년 2월 1일
처음 게시됨 (추정)
2012년 2월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 3월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 3월 18일
마지막으로 확인됨
2014년 3월 1일
추가 정보
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