EUCTR2008-002623-85-FR进行中（未招募）1 期
A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE
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4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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.
- •MTX-naïve
- •In paid employment (either full-time or part-time), or in unpaid but measurable work such as caring for a family and home. (NOTE: enrolment is expected for a majority of subjects who are in paid employment on entry into the study).
- •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 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
- •Prior treatment with MTX
- •Received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist (e.g., a TNF monoclonal antibody or a soluble TNF receptor) or other biologic treatment for RA.
- •Pregnant or breast feeding women
- •Has any contra-indications listed in the European SmPC for ETN.
- •Use of investigational drug or device within 3 months prior to the first dose of test article administration.
- •Non-Responder status at the end of phase 1 participation
- •Non-Responder status at the end of phase 2 participation
研究者
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