The effect of IL-1 inhibition by anakinra in acute gout;- A proof of concept study
- Conditions
- Gout.10023213
- Registration Number
- NL-OMON40227
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Patients with a crystal-confirmed diagnosis of gout
Patients with known intolerance or contra-indications for colchicine and NSAIDs and relative contra-indications to systemic prednisolone.
Patients with a currently acute gout flare
Patients with latent (or active) tuberculosis,
Positive serology for hepatitis B or C,
Patients with diabetes mellitus,
Patients with an extended history of cardiovascular disease
Patients s with a creatinine clearance less than 30 ml/min
Patients willing to receive an standard treatment conform the ACR guidelines 2012 and who do not agree to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The reduction in VAS (Visual Analog Scale) pain after 72 hours of anakinra<br /><br>treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The changes in markers of inflammation and endothelial function, changes in<br /><br>arterial stiffness and microcirculation after 7 and 21 days of treatment with<br /><br>anakinra. </p><br>