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2014年3月27日

概览

暂无简介。

注册库

who.int

开始日期

2014年3月27日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Reade

•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

•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.