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The effect of IL-1 inhibition by anakinra in acute gout;- A proof of concept study-

The effect of IL-1 inhibition by anakinra in acute gout;- A proof of concept study- - The effect of IL-1 inhibition by anakinra in acute gout

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40227
Enrollment
20
Registered
2014-06-26
Start date
2017-03-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout.

Interventions

All included patients will receive anakinra, 100 mg o.d. by subcutaneous injection for 3 consecutive days. The first injection needs to be administred within 24 hours after the acute attack is first

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The reduction in VAS (Visual Analog Scale) pain after 72 hours of anakinra treatment.

Secondary

MeasureTime frame
The changes in markers of inflammation and endothelial function, changes in arterial stiffness and microcirculation after 7 and 21 days of treatment with anakinra.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)