Rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039080 Term: Rheumatoid factor positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
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)
Conc
Sponsors
Reade
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether statin treatment can prevent or delay the development of RA in persons at increased risk of RA.;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.;Primary end point(s): The development of arthritis (=1 swollen joint) is the primary outcome measure. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactReade
Reade
Outcome results
None listed