EUCTR2008-002623-85-IT进行中（未招募）不适用
A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 300 人开始时间: 2009年6月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Female or male 18 years of age or older.
- •Meets the 1987 American College of Rheumatology (ACR) Revised Criteria for Rheumatoid Arthritis.
- •Had symptom (swollen joints) onset 12 months or less from date of enrollment.
- •Is MTX- na?ve.
- •In paid employment, either full or part time OR in unpaid but measurable work, such as caring for a family and home. (NOTE: The study target is to enroll a majority of subjects who are in paid employment on entry into the study.)
- •Has a DAS28>3.2.
- •Responder status at the end of phase 1 participation: subject with DAS28≤3.2 at the week 39 visit and DAS28<2.6 at the week 52 visit.
- •Responder status at the end of phase 2 participation: subject in remission (DAS28<2.6) or with low disease activity (2.6≤ DAS28≤3.2) at the week 91 visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Received prior treatment with MTX.
- •Received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist (eg, a TNF monoclonal antibody or a soluble TNF receptor) or other biologic treatment for RA.
- •Is a pregnant or breast feeding woman
- •Has any contraindications listed in the European Summary of Product Characteristics (SmPC) for ETN.
- •Used investigational drug or device within 3 months prior to the first dose of test article administration.
- •Nonresponder status at the end of phase 1 participation.
- •Nonresponder status at the end of phase 2 participation.
研究者
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