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临床试验/NCT01543594
NCT01543594招募中不适用

Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis

Gruppo Italiano Studio Early Arthritis1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1

研究概览

简要总结

The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.

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
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
  • Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
  • Patients eligible to begin conventional biologic therapy

排除标准

  • Any criteria excluding treatment with biologic drugs according to international guidelines

研究者

发起方
Gruppo Italiano Studio Early Arthritis
申办方类型
Network
责任方
Principal Investigator
主要研究者

Prof. Florenzo Iannone

Associate Professor of Rheumatology, University of Bari

Gruppo Italiano Studio Early Arthritis

研究点 (1)

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