Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial

INTERVENTION: Trade Name: Atorvastatin Product Name: Atorvastatin Product Code: C10AA05 Pharmaceutical Form: Tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523‐00‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Rheumatoid arthritis ; MedDRA version: 19.0 Level: PT Classification code 10039080 Term: Rheumatoid factor positive System Organ Class: 10022891 ‐ Investigations Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To investigate whether statin treatment can prevent or delay the development of RA in persons at increased risk of RA. Primary end point(s): The development of arthritis (=1 swollen joint) is the primary outcome measure. Secondary Objective: Changes in serum lipids, calculated 10‐year risk of cardiovascular events (in participants aged 40 years and over), changes in cIMT and arterial stiffness are secondary outcome measures. Timepoint(s) of evaluation of this end point: 3 years SECONDARY OUTCOME: Secondary end point(s): Serum lipids, calculated 10‐year risk of cardiovascular events (in participants aged 40 years and over), changes in cIMT and arterial stiffness are secondary outcome measures. Timepoint(s) of evaluation of this end point: Each year INCLUSION CRITERIA: 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