Clinical trial: Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation (NCT04844814)

Eligibility criteria:
Inclusion Criteria:

          -  Adults aged over 18 years old

          -  Gout confirmed by identification of urate crystals by joint fluid or tophus analysis
             or by ultrasound of the affected joint or

          -  Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the
             following items:

        Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1)
        (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease
        (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts)

          -  Chronic kidney disease stage 4/5 or renal transplantation

          -  Flare ≤ 5 days

          -  Pain assessed by visual analogical scale ≥ 5

        Exclusion Criteria:

          -  Participating in another trial including the administration of a drug

          -  Active infection

          -  History of anakinra or prednisone allergy

          -  Contra-indication of anakinra or prednisone

          -  Neutrophil count < 1000/mm3 (not due to ethnic cause)

          -  Difficulty understanding French

          -  Illiteracy

          -  Pregnant women or breastfeeding mothers (see PHC article L.1121-5)

          -  Persons deprived of liberty by judicial or administrative decision, persons receiving
             psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a
             health or social institution for purposes other than research (see CSP Article
             L.1121-6)

          -  Major persons subject to a measure of legal protection or unseeding to express consent
             (see PHC Article L.1121-8)

          -  Persons not affiliated to a social security plan or beneficiaries of such a plan (see
             PHC Article L.1121-8-1)
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? Contradiction