A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis

A Randomized, Double-blind, Active-control, Multicenter, Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra Compared to Intramuscular Triamcinolone in the Treatment of Acute Gouty Arthritis, Followed by an Extension Period of up to 2 Years

The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The patients will be divided in different treatment groups to compare anakinra to the available drug triamcinolone.

Patients will be randomized to treatment at their first gout flare in the study. The first treatment period will be followed by an extension period during which the patients will receive the same treatment for any subsequent flares within 52 weeks of randomization of last patient in the study. The extension period for the individual patient in the study will be maximum two years (104 weeks). Each new flare treated will initiate a new series of study visits and assessments according to specified schedule of events. Only if a patient experience a new flare after Day 15 of the latest flare they can start a new treatment period. The comparison of primary interest is between anakinra (100 mg and 200 mg combined) and 40 mg triamcinolone, and as a secondary objective the 2 different doses of anakinra will be evaluated as well as assessment for subsequent flares.

Inclusion Criteria:

• Signed Informed consent
• Patient meeting the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2015 gout classification criteria
• History of ≥1 self-reported flares of gouty arthritis within 12 months
• Current ongoing flare of gouty arthritis characterized by pain intensity
• Currently tender and swollen joint
• Onset of current flare within 4 days
• Intolerant, unresponsive, contraindicated or not appropriate for treatment with NSAIDs and colchicine (both treatment options)
• If on urate-lowering therapy, on a stable dose and regimen
• Women of childbearing potential willing to use adequate contraception

Inclusion criteria for treatment of subsequent flare(s)

• Current flare of gouty arthritis characterized by pain intensity
• Currently tender and swollen joint
• Women of childbearing potential willing to use adequate contraception

Exclusion Criteria:

• Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor inhibitors) within specified periods prior to randomization
• Contraindication to triamcinolone
• Polyarticular gouty arthritis involving more than 4 joints
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
• History of malignancy within the past 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy.
• Known hypersensitivity to Escherichia coli-derived proteins, Kineret® (anakinra), Kenalog® (triamcinolone acetonide) or any components of the products.
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection
• Presence of severe renal function impairment chronic kidney disease (CKD) stages 4 and 5
• Presence of neutropenia
• Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system or hepatic disease
• History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, New York Heart Association (NYHA) class III or IV heart failure within the previous 3 months
• Patients who have undergone major surgery within 2 weeks, or have an unhealed operation wound/s
• Presence of any medical or psychological condition or laboratory result that in the opinion of the investigator might create risk to the patients or to the study.
• Earlier or current treatment with anakinra
• Pregnant or lactating women
• History of >12 flares overall in the 6 months prior to randomization

Exclusion criteria for treatment of subsequent flare(s):

• Known presence or suspicion of active or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection.
• Presence of severe renal function impairment CKD stages 4 and 5
• Presence of neutropenia
• History of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting, NYHA class III or IV heart failure within the previous 3 months
• Patients who have undergone major surgery within 2 weeks or have an unhealed operation wound/s.
• Pregnant or lactating women.
• Presence of any condition or laboratory result that in the opinion of the investigator makes the patient not appropriate for treatment