A Prospective, Multicentre, Non-interventional, Observational, Cohort Study to Evaluate the Long Term Clinical, Patient Reported and Health Care Resource Utilization Effects of an Early Response to Certolizumab Pegol (Cimzia®) in Rheumatoid Arthritis Patients in Daily Clinical Practice in the United Kingdom and Eire.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 149
- 试验地点
- 22
- 主要终点
- Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points
研究概览
简要总结
To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.
详细描述
Clinical response will be assessed by the percentage of patients achieving a reduction from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points, which is considered the minimum clinically important difference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent is signed and dated
- •The patient is considered capable of and prepared to adhere to the study protocol procedures
- •The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
- •The patient is screen-negative for tuberculosis
- •The patient is 18 years of age or above
排除标准
- •The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
- •Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
- •Patient has participated in another study within the last 30 days
- •Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
- •Patient has inadequate literacy to understand and complete the questionnaires.
- •Contraindications stated in the SmPC
- •Patient is pregnant or breast feeding
结局指标
主要结局
Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points
时间窗: Baseline (Week 0), 78 weeks
DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 \* √(TJC) + 0.28\* √(SJC) + 0.70\* ln(ESR) + 0.014\* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.
次要结局
- Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks(Baseline (Week 0), 78 weeks)
- Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline(Baseline (Week 0), 78 weeks)
- Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks(Baseline (Week 0), 78 weeks)
- Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks(Baseline (Week 0), 78 weeks)