Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAI

Merck Serono International S.A.0 个研究点目标入组 92 人开始时间: 2008年8月25日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 92

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Subject participating to Study 25878 currently treated or having been treated with
•efalizumab, with the last dose received within 6 weeks before inclusion in this trial.
•2) Subject developing during the study 25878 either
•- A newly diagnosed autoimmune disease (suspected or confirmed) such as
•systemic lupus erythematosus, Wegener’s granulomatosis, antiphospholipid
•syndrome, Sjögren syndrome, rheumatoid arthritis, multiple sclerosis, diabetes
•type I, autoimmune uveoretinitis, autoimmune gut disorders such as Crohn
•disease or ulcerative colitis, autoimmune vasculitis, autoimmune hepatitis,
•autoimmune thyroiditis and other endocrine disorders, autoimmune haemolytic
•anaemia, pernicious anaemia, myasthenia gravis, Goodpasture’s syndrome,
•and Guillain-Barré syndrome, or
•- A severe thrombocytopenia defined as grade III or IV according to NCICTCAE
•criteria – i.e. platelet count < 50,000 mm3 - during routine monitoring
•or for -cause laboratory evaluation
•3) Subject is willing and able to participate in the trial and has provided signed, informed consent.
•In addition, for sites participating to the control group, control subjects will be included and must fulfil all the following criteria:
•1) Subject participating to Study 25878
•2) Absence of clinical signs of severe thrombocytopenia
•3) Either currently treated with efalizumab or not (i.e. last dose of efalizumab received more than 6 weeks before study entry)
•4) Subject is willing and able to participate in the trial and has provided signed, 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

排除标准

•1) Participation to any interventional clinical study (inclusion in other registry/ observational study is possible)
•2) Administration of specific treatment for the current thrombocytopenia before inclusion in the study (e.g. glucocorticosteroids, plasmapheresis, platelet transfusion)

研究者

发起方

Merck Serono International S.A.

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