Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 76
- 试验地点
- 9
- 主要终点
- Primary: Participants With EULAR (Good)
研究概览
简要总结
This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece
详细描述
All subjects enrolled should meet the usual prescribing criteria for Etanercept as per the local product information and should be entered into the study at the investigator's discretion
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
- •signed and dated informed consent document
- •18 years of age and older at the time of consent
- •Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
- •Patients who have been prescribed for first time to receive treatment with MTX + Etanercept prior to enrollment to this study, following routine clinical practice and according to the approved SmPC,
- •Patients with DAS28 ≥ 3.2
- •Duration of disease symptoms ≥ 6 weeks and ≤2 years
- •Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.
排除标准
- •Contraindications according to the SmPC
- •History of or present anti-TNFa or other biologic therapy for the treatment of RA
- •Known significant concurrent medical disease according to investigator's opinion and the current SmPC
研究组 & 干预措施
etanercept + methotrexate
干预措施: etanercept (Drug)
etanercept + methotrexate
干预措施: methotrexate (Drug)
结局指标
主要结局
Primary: Participants With EULAR (Good)
时间窗: Visit 4 (Month 6)
Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change \>1.2 with DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 \>5.1
次要结局
- Change From Baseline in Tender Joint Count at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Change From Baseline in HAQ-DI at Visit 4 (Month 6)(Baseline and Visit 4 (Month 6))
- Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)(Baseline and Visit 4 (Month 6))