跳至主要内容
临床试验/EUCTR2007-004757-28-GB
EUCTR2007-004757-28-GB进行中(未招募)1 期

A randomised controlled single-blind trial to compare intensive management vs standard care in early psoriatic arthritis - TICOPA

niversity of Leeds0 个研究点目标入组 206 人开始时间: 2008年3月14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
206

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

  • Patients with the following characteristics are eligible for the study:
  • 1.Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.
  • 2.Active disease defined by at least one tender or swollen joint or active enthesitis.
  • 3.Age =18 years at the time of signing the informed consent form and either male or female patients.
  • 4.Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.
  • 5.Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
  • 6.Adequate full blood count within 28 days before randomisation:
  • a.Haemoglobin count > 8.5 g/dL
  • b.White blood count (WBC) > 3.5 x 109/L
  • c.Absolute neutrophil count (ANC) > 1.5 x 109/L
  • d.Platelet count > 100 x 109/L
  • 7.Adequate hepatobiliary function within 28 days before randomisation:
  • a. ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test.
  • 8.The patient must be able to adhere to the study visit schedule and other protocol requirements.
  • 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

  • Patients will be excluded from this study for any of the following reasons:
  • 1.Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazone, leflunomide,
  • 2.Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
  • 3.Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.

研究者

发起方
niversity of Leeds

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