Clinical trial: A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis (NCT03002974)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Entailment