Primary:To evaluate the efficacy and safety of anakinra in the treatment of pain in patients with an acute gout attack during 3 days and subsequently assess the effect of anakinra treatment for 21 days in the prevention of recurrent gout attacks.…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction in VAS (Visual Analog Scale) pain after 72 hours of anakinra
treatment.
Secondary outcome
The changes in markers of inflammation and endothelial function, changes in
arterial stiffness and microcirculation after 7 and 21 days of treatment with
anakinra.
Background summary
Urate crystals stimulate the IL 1 production in monocytes and synovial
macrophages by inflammasomes. Recent evidence proposed a relationship between
urate and atherosclerosis. Based on this, it is likely that this mechanism
plays a role in the increased cardiovascular risk in gout patients.
Therefore, it is important to investigate the effect of the IL 1 inhibition by
interleukine antagonist anakinra on patients with acute gout. The objectives
of this trial are twofold. First, the reduction of pain in patients with acute
gout is investigated. Second the cardiovascular risk in gout patients is
investigated.
Study objective
Primary:To evaluate the efficacy and safety of anakinra in the treatment of
pain in patients with an acute gout attack during 3 days and subsequently
assess the effect of anakinra treatment for 21 days in the prevention of
recurrent gout attacks.
Secondary: To assess the effect of anakinra on the endothelium and
microcirculation of patients with acute gout attack during the study and
subsequently evaluate the impact of anakinra on cardiovascular risk, after
respectively 3 and 21 days of treatment.
Study design
Randomized, double-blind, clinical trial in patients with acute gout. All
included patients will receive anakinra, 100mg 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 reported. After 3 days patients will
either continue on anakinra, 100 mg o.d. by subcutaneous injection or switch to
placebo for the remaining 18 days of the study.
Intervention
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 reported. After 3 days patients
will either continue on anakinra, 100 mg o.d. by subcutaneous injection or
switch to placebo for the remaining 18 days of the study.
Study burden and risks
Consists of an extra blood sample and additionally measurements of endothelial
function.
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000173-39-NL |
| CCMO | NL46306.048.14 |