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
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