临床试验/ISRCTN37438295

ISRCTN37438295已完成4 期

Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis

King's College London (UK)0 个研究点目标入组 190 人开始时间: 2007年6月12日最近更新: 2022年10月10日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 190

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25351370 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25769495 results 2016 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/27651924 secondary analysis 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/30629813/ cost-effectiveness results (added 13/07/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36148396/ Characterization of missing data patterns and mechanisms (added 29/09/2022)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Males and females aged over 18 years
•2. Established RA by the criteria of the American College of Rheumatology
•3. Disease duration of at least 12 months
•4. Meet NICE criteria for being prescribed TNF inhibitors:
•4.1. Disease Activity Score (DAS) over 5.1
•4.2. Failure to respond to two DMARDs including methotrexate
•4.3. No contra-indications to TNF inhibitors (including possibility of pregnancy)

排除标准

•1. Unable or unwilling to give informed consent
•2. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy)
•3. Serious inter-current illness
•4. Patients on high dose steroids (in excess of 10 mg prednisolone or equivalent per day at trial entry)

研究者

发起方

King's College London (UK)

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进行中（未招募）

Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACITMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid Arthritis

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