Anakinra versus intramuscular methylprednisolone acetate for gout flares in people with chronic kidney disease (ASGARD): a UK randomised multicentre, double-blind, double-dummy controlled feasibility study with economic, qualitative and safety assessment

Objectives Anakinra versus steroids for gout flares in people with renal disease (ASGARD) is a feasibility trial of undertaking a double-blind, double dummy randomised controlled trial of Anakinra versus intramuscular methylprednisolone acetate in people with gout and chronic kidney disease.Design A two-arm parallel group, double-blind, double-dummy, multicentre, randomised controlled trial.Setting ASGARD was undertaken in four centres in secondary care.Intervention Subcutaneous anakinra 100 mg daily for 5 days versus intramuscular methylprednisolone acetate 120 mg for gout flares in people with chronic kidney disease (estimated glomerular filtration rate (eGFR) 2).Primary and secondary outcome measures Primary outcome measures were feasibility criteria of recruitment (32 participants over 15 months), enrolment of >70% of eligible participants, Results The feasibility trial did not meet its overall criteria for success due to under-recruitment. It met procedural feasibility of recruiting ≥70% of eligible patients and ≤10% treatment crossovers or failure, 85% of participants completing 5 out of 7 participant-reported pain assessments (excluding four participants who did not receive allocated treatment). 21 participants (mean age 72 years, mean eGFR 44 mL/min/1.73 m2) were randomised; 17 received per protocol treatment. Mean reduction in pain after 7 days was 46.8 from baseline by 100 mm visual analogue score. Anakinra appeared to have a shorter time to pain reduction; however, this must be confirmed in a larger trial. Functional and quality of life assessments were highly completed. Health resource use was higher when assessed by health records. Qualitative feedback from participants alluded to high questionnaire burden and delays in receiving treatment.Conclusions We demonstrated the feasibility of conducting a definitive randomised controlled trial with insights from treatment effects, safety data, reconciliation of assessments, economic evaluation and participant experience. Improved case finding in the community, with streamlined processes during gout flare should be explored before recommendation for future trial can be made.Trial registration numbers EudraCT No. 2015-001787-19. NCT/ClinicalTrials.gov No. NCT02578394. WHO Universal Trials Reference No. U1111-1175-1977.