acute gout, anakinra, interleukin-1, pain, acute jicht, pijn, urate-lowering therapy
Conditions
Interventions
Intervention group:
generic name: anakinra, subcutaneous injections
dose: 100 mg/day
treatment duration: 5 days
Active control: (1 of the 3 treatment regimes)
1. generic name: colchicine
dos
Sponsors
prof. dr. M.A.F.J. van de Laar
Eligibility
Inclusion criteria
Inclusion criteria: • At least 18 years of age • Signed written informed consent. • Identification of intracellular MSU crystals in primary joint through aspiration of joint
Exclusion criteria
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 • Presence of liver disease that according to the treating physician precludes participation in the study • Absolute contra-indication for all three of the possible SoC treatments (colchicine, naproxen, prednisolon) • Known history of allergy or sensitivity to latex • Current us of any ULT (ULT therapies are allopurinol, febuxostat and benzbromaron) • Concurrent use of other IL-1 agents • Pregnancy or lactation • Women who are planning on becoming pregnant within the study period (12 months) • Patients with active or recurrent bacterial, fungal or viral infection • Patients using TNF inhibitors • Patient has insufficient knowledge of the Dutch language for completing questionnaires independently • Patient reports no to mild gout related pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in patient-reported pain in the index joint from baseline to the average of pain values at 24, 48, 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to 50% reduction in pain in the primary affected joint • Time to remission of pain • Time to first reoccurrence of flare • Number of new flares • Decrease of primary joint swelling according to patient across day 2-5 • Decrease of primary joint tenderness according to patient across day 2-5 • Decrease in C-reactive protein (CRP) levels after 7 days of treatment • Decrease of serum uric acid concentration after 3 months • Treatment response according to patient across day 2 -7 • % dropout due to adverse events (AE) • % dropout due to serious adverse events (SAE) • physical function • Health related quality of life (HR-QOL) • Experienced side effects • Direct and indirect costs • % patients starting with canakinumab treatment • % patients with serum uric acid concentration ≤ 0.36 mmol/l | — |
Contacts
Public ContactCarly A. Janssen
University of Twente - Faculty of BMS - PGT
Outcome results
None listed