NL-OMON44914已完成3 期
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 0 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
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
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