A Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's disease (AOSD) including an open-label long term extension. - CONSIDER

Charité - Universitätsmedizin Berlin0 个研究点目标入组 36 人开始时间: 2011年12月5日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•written informed consent
•men and women = 18 years and = 75 years
•diagnosis of adult onset Still's disease according Yamaguchi et al. criteria (J Rheumatology 1992)
•disease activity (DAS28 >3,2) at Screening
•joint involvement defined as minimum 4 painfull and 4 swollen joints at Screening and Baseline (28 joint count)
•if treated with NSAID's: stable treatment for a minimum of 2 weeks prior to randomisation
•if treated with corticosteroids: stable treatment for a minimum of 1 week prior to randomisation (= 10 mg/ day)
•if on conventional DMARD therapy: stable treatment for a minimum of 6 weeks prior to randomisation
•washout of biologic DMARD's
•effective method for contraception
•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•prior treatment with two or more doses of IMP
•intraarticular or intravenous injection with corticosteroids 4 weeks before randomisation
•treatment with narcotic analgetics (excluding permitted concomitant medications such as Tramadol and Codein)
•diagnosis of other, severe, chronic-inflammatory diseases
•positive hepatitis B Antigen (HBsAg), hepatitis C antibody and/ or HIV-antibody
•relevant active infection
•positive screening for latent tuberculosis (if patient is taking adequate/isoniazid prophylaxis for 4 weeks before first IP administration, this patient may be randomized.)
•elevated lab results: AST, ALT Bilirubin, Creatinine
•non adequate hematologic lab result
•history of neoplasm (with exception of curative treated non-melanoma neoplasm of the skin and carcinoma in situ of cervix)
•relevant cardial or pulmonary diseases
•macrophage activating syndrome (MAS)
•vaccination with life vaccine
•a history of alcohol or drug abuse within last 12 months
•blood donation or blood loss = 400 ml within last 8 weeks
•pregnancy or breastfeeding

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