A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Anakinra 100 mg; Triamcinolone Acetonide 40 mg; Placebo to Anakinra 100 mg; Placebo to Triamcinolone Acetonide 40 mg
Intervention description: 100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection; 1 mL intramuscular injection of a 40 mg/mL injectable suspension; sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe; 1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Interleukin 1 Receptor Antagonist Protein; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; Interleukin 1 receptor antagonist; IL-1 receptor antagonist

Summary:

      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.
    

Eligibility criteria:

        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