ISRCTN95861172已完成不适用
Randomised Efficacy and Discontinuation Study of Etanercept and Adalimumab (RED SEA): A pragmatic open label study in rheumatoid arthritis
niversity Hospital Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 124 人开始时间: 2007年9月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The participants will be patients with rheumatoid arthritis who attend the Rheumatology Outpatients Department at Selly Oak, City or Solihull Hospitals in Birmingham and St Mary's Hospital, Newport, Isle of Wight. They will be identified as likely to fulfill NICE criteria for receiving a TNF-inhibitor and will be provided with written information about this study and these drugs. Patients will then attend a hospital clinic where their Disease Activity Score (DAS) will be measured, to ensure they meet National criteria. Their medical history will be reviewed at that clinic visit to ensure that there are no contra-indications to them receiving a TNF
- •inhibitor. In addition any screening procedures for tuberculosis or any other areas of clinical concern will be
- •completed. At this time, in cases where patients or clinicians have a strong preference for a particular TNF
- •inhibitor (any one of adalimumab, etanercept or infliximab), a plan of treatment will be agreed with patients.
- •Other patients - we believe a majority of those eligible for a TNF inhibitor - will be asked whether they are willing to be involved in this study. It will be explained to them that, in the study, they will be randomly allocated to adalimumab or etanercept. The study and drug information leaflets will be discussed in detail and any questions answered. All patients will have had the opportunity to think about their treatment options for at least 24 hours by this time. A consent form will be completed for patients willing to be involved.
- •1. Men and women over the age of 18 years with rheumatoid arthritis meeting international disease
- •classification criteria.
- •2. NICE Criteria for treatment with TNF inhibitors in regard to lack of response to at least two DMARDs (one of which must be methotrexate at adequate doses and for a defined period of time - according to NICE criteria).
- •3. Willing to enter study and able to understand the procedures and comply with the study protocol
排除标准
- •1. Any condition(s) which, in the opinion of the physician caring for the patient, makes that patient unsuitable for a TNF inhibitor for their arthritis
- •2. Any individual unable to understand study procedures or unwilling to comply
- •3. Previous treatment with any licensed or experimental biological TNF inhibitor
研究者
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