Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT

King's College London0 个研究点目标入组 190 人开始时间: 2007年4月17日最近更新: 2018年12月4日

适应症

试验速览

暂无简介。

•a. Males and Females aged over 18 years
•b. Established RA by the criteria of the American College of Rheumatology
•c. Meet NICE criteria for being prescribed TNF inhibitors
•Disease Activity Score (DAS) over 5.1 confirmed on at least two occasions 1 month apart
•Failed trials of two disease modifying anti-rheumatic drugs (DMARDs), including Methotrexate (unless contra-indicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at a standard dose, unless significant toxicity has limited the dose or duration of treatment
•No contra-indications to TNF inhibitors (including possibility of pregnancy).
•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

•a. Unable or unwilling to give informed consent
•b. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy)
•c. Serious inter-current illness
•d. Patients on high dose steroids (in excess of 10mg prednisolone or equivalent per day at trial entry)
•e. Current steroid therapy or previous therapy within the last month (oral therapy at a dose in excess of 10mg prednisolone or equivalent per day and/or intra-muscular steroid injections)

发起方