Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial - STAtins to Prevent Rheumatoid Arthritis (STAPRA)

Reade0 个研究点目标入组 220 人开始时间: 2014年3月27日最近更新: 2020年6月29日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 220

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) Age >= 18 years
•2) Seropositive
•-IgM-RF and ACPA positive OR
•-High ACPA titer (>3x cut-off)
•3) With or without current joint pain, but without current clinical synovitis (ultrasound exam should not be performed in case of doubt, since US was shown to be often false-positive in this patient group)
•4) 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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

排除标准

•1) Patients with synovitis during clinical examination (any of 44 joints of DAS) at inclusion or synovitis in the past during clinical examination by a rheumatologist.
•2) Patients with typical RA erosions on X-rays of hand and feet.
•3) In case of inclusion depending on the presence of RF, the presence of situations with possible false-positive RF: known active infection with hepatitis C or Ebstein-Barr virus or recent radiotherapy.
•4) Use of statins or other lipid-lowering agents within the last three months.
•5) A history of previous use of statins discontinued due to side effects.
•6) Patients with an indication for statin therapy according to local guidelines. All patients will be screened pior to randomisation
•7) Previous use of DMARDs other than hydroxychloroquine, or use of hydroxychloroquine within the last three months.
•8) A history of oral or parenteral use of corticosteroids within the last 12 weeks used to treat the current episode of musculoskeletal symptoms.
•9) Subjects with current severe, progressive, or uncontrolled, hematologic disease, gastrointestinal disease, (diabetes with a serum glucose >7.0 mmol/L), pulmonary, cardiac, neurologic, or cerebral disease.
•10) Subjects who are pregnant or who are breastfeeding or wish to become pregnant.
•11) Subjects who currently abuse recreational drugs
•12) Subjects who have a limited life expectancy.
•13) Subjects who are unable to fill out the questionnaires.
•14) Subjects who are using ciclosporin (which interacts with statins).

研究者

发起方

Reade

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