Anakinra versus treatment as usual in the treatment of acute gout

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

* At least 18 years of age
* Signed written informed consent
* Identification of intracellular monosodium urate crystals in primary joint through aspiration of joint

Exclusion Criteria

* Absolute contra-indication for all available types of urate lowering therapy (allopurinol, febuxostat and benzbromaron)
Contra-indications allopurinol: Hypersensitivity to the active substance or to any of the excipients (see for the excipients the official SPC for the brand given).
Contra-indications febuxostat: Hypersensitivity to the active substance or to any of the excipients (see for the excipients the official SPC for the brand given).
Contra-indications benzbromaron: Hypersensitivity to the active substance or to any of the excipients (see for the excipients the official SPC for the brand given). Patients with known liver disease. Concomitant use of hepatotoxic drugs, particularly antituberculosis agents. Hepatic porphyia. Severe renal impairment (clearance < 30 ml/min.). Patients with secretion of urate higher than 700 mg/24 hours (= 4.2 mmol/24 hour).Urolithiasis. Acute gout flare. ;* Absolute contra-indication for anakinra
Contra-indications anakinra: Hypersensitivity to the active substance or to any of the excipients (citric acid anhydrous, sodium chloride, disodium edetate dihydrate, polysorbate 80, sodium hydroxide, water for injections) or to E. coli derived proteins. Kineret must not be used in patients with severe renal impairment (creatinine clearance rate < 30 ml/minute). Kineret treatment must not be initiated in patients with neutropenia (absolute neutrophil count <1.5 x 109 /l). ;* Presence of liver disease that according to the treating physician precludes participation in the study;* Absolute contra-indication for all three possible standard of care treatments (colchicine, naproxen, prednisolon)
Contra-indications colchicine: Hypersensitivity to the active substance or to any of the excipients (microcrystalline cellulose (E460), lactose, sodium carboxy starch, magnesium stearate (E470b)). Women of childbearing age, unless effective contraceptive measures are taken. Colchicine should not be used in patients with severe renal impairment or severe hepatic impairment.
Contra-indications naproxen: Hypersensitivity to the active substance or to any of the excipients (potato starch, lactose, hydroxypropyl cellulose (200 CP), magnesium stearate, colloidal anhydrous silicon dioxide). Naproxen is contra-indicatied in patients who have previously shown allergic reactions (e.g. asthma, rhinitis or urticaria) in response to acetylsalicylic acid or other prostaglandin-synthesis inhibitors. Severe anaphylactoid reactions have been reported in these patients. In principle, naproxen must not be administered to patients with gastrointestinal ulcerations, congestive gastritis or atrophic gastritis, gastrointestinal bleeding or other bleeding such as cerebrovascular bleeding. Severe renal impairment.
Contra-indications prednisolon: Hypersensitivity to the active substance or to any of the excipients (lactose, magnesium stearate (E470b), silicon dioxide (E551), potato starch, pregelatinized potato starch, sodium (potato) starch glycolate, magnesium stearate (E572), erythrosine (E127)). Gastric and duodenal ulcers. Acute infectious processes, particularly viral infections and systemic fungal infections. Tropical worm infections. Administration after vaccination with a live attenuated virus. Ocular herpes simplex.;* Known history of allergy or sensitivity to latex;* Current use of any ULT (ULT therapies are allopurinol, febuxostat and benzbromaron);* Concurrent use of other IL-1 agents (to this categor

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in patient-reported pain in the index joint from baseline to the average<br /><br>of pain values at 24, 48 and 72 hours </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to 50% reduction in pain in the primary affected joint<br /><br>Time to remission of pain<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 event (AE)<br /><br>% dropout due to serious adverse event (SAE)<br /><br>Level of physical functioning<br /><br>Health related quality of life (HR-QOL)<br /><br>Experienced side effects<br /><br>Direct and indirect costs<br /><br>Time to first reoccurrence of flare<br /><br>Number of new flares<br /><br>% patients starting with canakinumab treatment<br /><br>% patients with serum uric acid concentration * 0.36 mmol/l</p><br>

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