STAtins to Prevent Rheumatoid Arthritis (STAPRA)

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 19.0Level: PTClassification code 10039080Term: Rheumatoid factor positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-005524-42-NL
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-27
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified