A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 0 人开始时间: 2005年7月14日最近更新: 2019年11月25日

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•Adult males or females (females of childbearing and non-childbearing potential) without clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, metabolic, genitourinary, neurological and psychiatric disease as determined by history, physical examination and screening investigations
•Aged = 18 years
•Body weight = 50 kg for males and = 45 kg for females, who are not morbidly obese
•The subject has a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR)
•The subject has active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness
•Stable doses of DMARDs (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrolment
•Subjects receiving methotrexate must be on stable folate supplements
•Subjects using NSAIDs or Cox-2 inhibitors must have been on stable doses for 2 weeks prior to screening
•LFT functions (ALT, AST, ALP) = 1.5 x ULN at screening and which have been stable on at least 2 occasions in the 7 months prior to screening
•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

•Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
•Clinically significant abnormalities in safety laboratory analysis at screening
•Pregnant or nursing women
•Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in Section 5.2.3
•The subject is using, or has used, oral glucocorticoids within 8 weeks of enrolment
•The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
•The subject received their final dose of infliximab or adalimumab within 3 months of enrolment
•The subject received their final dose of etanercept or anakinra within 1 month of enrolment
•The subject has a screening QTc value of >430msec (males) or >450msec (females), PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave)
•History of liver or renal disease in the 6 months prior to screening
•Current renal insufficiency (subject must have an estimated creatinine clearance =50mL/min

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