NL-OMON44914
Completed
Phase 3
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- arthritis
- Sponsor
- Reade
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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