EUCTR2012-005214-19-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis - An RCT of golimumab+MTX vs MTX alone in MTX-naive PsA
Academic Medical Center, Department of Rheumatology0 个研究点目标入组 60 人开始时间: 2013年6月20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
- 60
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
入选标准
- •- Psoriatic arthritis according to the CASPAR classification
- •- Active disease, minimally 3 swollen and tender joints
- •- 18-70 years
- •- a stable dose of concomitant NSAIDs and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent = 10 mg/day and must be stable for at least 4 weeks prior to baseline.
- •- Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG).
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Methotrexate naive
- •TNF blocker naive
- •Concurrent DMARD use
- •Malignancy <5 years ago
- •no active children wish, pregnancy or breast feeding
研究者
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