Anakinra versus treatment as usual in the treatment of acute gout // Anakinra versus standaardbehandeling bij acute jicht
Recruiting
- Conditions
- acute gout, anakinra, interleukin-1, pain, acute jicht, pijn, urate-lowering therapy
- Registration Number
- NL-OMON28223
- Lead Sponsor
- prof. dr. M.A.F.J. van de Laar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
• At least 18 years of age
• Signed written informed consent.
Exclusion Criteria
• Absolute contra-indication for all available types of ULT (allopurinol, febuxostat and benzbromaron)
• Absolute contra-indication for anakinra (i.a. creatinine clearance rate < 30 ml/ minute
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in patient-reported pain in the index joint from baseline to the average of pain values at 24, 48, 72 hours
- Secondary Outcome Measures
Name Time Method • Time to 50% reduction in pain in the primary <br> affected joint<br /><br>• Time to remission of pain<br /><br>• Time to first reoccurrence of flare<br /><br>• Number of new flares<br /><br>• Decrease of primary joint swelling according to patient across day 2-5 <br /><br>• Decrease of primary joint tenderness according to patient across day 2-5 <br /><br>• Decrease in C-reactive protein (CRP) levels after 7 days of treatment <br /><br>• Decrease of serum uric acid concentration after 3 months<br /><br>• Treatment response according to patient across day 2 -7<br /><br>• % dropout due to adverse events (AE)<br /><br>• % dropout due to serious adverse events (SAE)<br /><br>• physical function <br /><br>• Health related quality of life (HR-QOL)<br /><br>• Experienced side effects<br /><br>• Direct and indirect costs <br /><br>• % patients starting with canakinumab treatment<br /><br>• % patients with serum uric acid concentration ≤ 0.36 mmol/l<br>