A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA

MC0 个研究点目标入组 12 人开始时间: 2010年12月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1) Diagnosis of RA, classified by ARA (American Rheumatism Association) 1987 revised criteria.
•2) Active disease at screening and baseline: 6/68 tender and 6/66 swollen joints and either an erythrocyte sedimentation rate (ESR) of >=28 mm/hr or C-reactive protein (CRP)> 10 mg/l
•3) Written informed consent
•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

•1) Current or previous treatment with biological agent
•2) Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to rheumatoid arthritis (as judged by the investigator)
•3) Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception
•4) Participation in an investigational drug trial, current or in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
•5) Use of erythropoietin
•6) Inability to follow the protocol and to comply with the follow up requirements
•7) Clinically relevant abnormal history of physical and mental health other than conditions related to rheumatoid arthritis, as determined by medical history taking (as judged by the investigator) or any other condition that in the opinion of the investigator would complicate or compromise the well being of the subject.

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