Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA

King's College London0 个研究点目标入组 97 人开始时间: 2010年8月17日最近更新: 2019年12月10日

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•a.RA by the criteria of the American College of Rheumatology
•b.Etanercept or adalimumab treatment for at least 6 months (a break of up to 4 consecutive weeks is permitted).
•c.Taking at least one DMARD from the list in the study protocol
•d.Stable clinical response for at least 3 months (one DAS28 score of at least 3.2; no changes in DAS28 >0.6 in the last 3 months)
•e.Patient considers he or she has achieved a suitable response to TNF inhibitors
•f.Supervising rheumatologist considers further improvements are unlikely on the patient’s current treatment regimen.
•g.At least 18 years of age
•h.Willing and able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 99
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 99

•a.Serious concurrent illness (e.g. terminal cancer)
•b.Prednisolone at more than 10mg daily (for doses > 10mg daily, a 4 week washout period is required)
•c.Recently received IM/IA steroids (4 weeks washout required)
•d.Participation in another clinical trial (other than observational or lifestyle studies and registries) concurrently or within 12 weeks of screening
•e.Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception

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