Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study

Inclusion Criteria:

1. Subjects capable of giving informed consent.
2. Male or non-pregnant, non-nursing female
3. ≥ 18 years of age
4. eGFR < 60mls/min/1.73m2 and ≥ 30mls/min/1.73m2 as calculated using serum creatinineand modified MDRD formula as per renal association guidelines.
5. Diagnosis of gout arthritis as defined by the American College of Rheumatology 1977preliminary criteria (this criteria is currently endorsed by NICE guidelines).
6. Gout flare less ≤ 36 hours
7. Baseline pain intensity > or equal to 50mm on the 0-100 mm VAS. In the case ofmultiple joints (≤ 3), the most affected joint will be assessed.

Exclusion Criteria:

1. Treatment with NSAIDS in last 48 hours, systemic steroids in last 4 weeks orcolchicine within 7 days.
2. Polyarticular gout, i.e. affecting four or more 4 joints
3. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or otheracute inflammatory arthritis such as systemic lupus erythematosus, mixed connectivetissue disease, scleroderma, polymyositis, or significant systemic involvementsecondary to rheumatoid arthritis.
4. Con-current immunosuppression/immunomodulatory treatment (Calcineurin inhibitor,anti-proliferative or biologic) therapy for other reason i.e. organ transplant.
5. Prior history or current inflammatory joint disease other than gout (e.g. rheumatoidarthritis (RA), reactive arthritis, psoriatic arthritis, seronegativespondyloarthropathy, Lyme disease). Concurrent medication for RA like methotrexate andanti-TNF treatment has been associated with increased risk of neutropenia andinfection.
6. Current active malignancy (with the exception of basal cell or squamous cell carcinomaof the skin, cervical intraepithelial neoplasia and non-metastatic/advanced prostatecancer).
7. Any patients with contra-indication to intramuscular injection such as coagulopathy orthrombocytopenia (Platelet count<100 x 109/L (100,000/mm3)).
8. Abnormal liver function tests: Total bilirubin>upper limit of normal, Alanineaminotransferase (ALT) or Aspartate Aminotransferase (AST) >2 times upper limit ofnormal.
9. Haemoglobin <85g/L (8.5 g/dL)
10. White blood cell (WBC) count<1.5 x 109/L (1000/mm3), absolute neutrophil count<1.5 x 109/L (1000/mm3)
11. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), hepatic, endocrine (including uncontrolleddiabetes) or gastrointestinal disease.
12. Known positive hepatitis B virus surface antigen (HBsAg), hepatitis C (HCV) antibodyor HIV.
13. Females of child bearing potential who are not willing to use highly effective birthcontrol methods from the time of consent to one week after treatment discontinuation.Highly effective method of contraception (hormonal or barrier method of birth control;abstinence) consist of:

• Combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation; oral, intravaginal, transdermal.
• Progestogen-only hormonal contraception associated with inhibition of ovulation;oral, injectable, implantable.
• Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion or vasectomised partner
• Sexual abstinence

14. Females of childbearing potential must have a negative pregnancy test (highlysensitive urine or serum pregnancy test after a confirmed menstrual period) within 7days prior to treatment initiation. Subjects are considered not of child bearingpotential if they are surgically sterile (i.e. they have undergone a hysterectomy,bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
15. Females must not be breastfeeding.
16. Patients who have had treatment as part of this trial cannot have repeat treatment foranother flare as part of the trial.
17. Patient with allergies to excipients of IMPs: citric acid, anhydrous, sodium chloride,disodium edetate dehydrate, polysorbate 80, sodium hydroxide. Hypersensitivity to E.Coli derived proteins, egg proteins and soy proteins. Patients with a latex allergyare also not eligible as the inner needle cover of the pre-filled syringe contains drynatural rubber (a derivative of latex).