跳至主要内容
临床试验/EUCTR2009-012424-87-GB
EUCTR2009-012424-87-GB进行中(未招募)1 期

T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF

Imperial College London South Kensington London0 个研究点目标入组 55 人开始时间: 2009年10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
55

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

  • - Anti-TNF naive patients
  • - Patients due to start treatment with anti-TNF blocking drugs - etanercept or adalimumab
  • - Patients with rheumatoid arthritis should meet the 1987 American College of Rheumatology (ACR) revised classification criteria, should have active rheumatoid arthritis as defined by a DAS28 score >5.1 and should be on a stable dose of disease-modifying drugs for the previous 1 month and a stable dose of glucocorticoids for at least 4 weeks prior to study entry.
  • -Patients with psoriatic arthritis should have a secure diagnosis confirmed by a rheumatologist and concurrent psoriatic skin lesions. If on disease-modifying therapy, patients should be on a stable dose for the the previous 1 month prior to study entry.
  • -Patients with ankylosing spondylitis should fulfill the Modified New York Criteria for diagnosis of ankylosing spondylitis and if taking disease-modifying therapy, they should be on a stable dose for the previous 1 month prior to study entry.
  • 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 who have been previously treated with anti-TNF therapy for whatever reason
  • - Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who do not fulfill the diagnostic criteria for these conditions as above.
  • - Patients who have received an intra-articular injection of steroids or have received an intramuscular injection of depot steroid to treat disease flare in the preceding 4 weeks prior to commencing anti-TNF therapy.
  • - Patients with intercurrent, active infection of any type, excluding the common cold.

研究者

发起方
Imperial College London South Kensington London

相似试验