Clinical trial: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy (NCT03905512)

Eligibility criteria:
Inclusion Criteria:

          1. History of symptomatic gout defined as:

               1. ≥ 3 gout flares within 18 months of Screening or

               2. Presence of ≥ 1 tophus or

               3. Current diagnosis of gouty arthritis

          2. At the Screening Visit: male age 21 - 80 years, inclusive, or female of
             non-childbearing potential age 21-80 years, inclusive, where non-childbearing
             potential is defined as:

               1. > 6 weeks after hysterectomy with or without surgical bilateral
                  salpingooperhectony or

               2. Post-menopausal (> 24 months of natural amenorrhea)

          3. Has at the Screening Visit SUA ≥ 7 mg/dL, with chronic refractory gout defined as
             having failed to normalize SUA and whose signs and symptoms are inadequately
             controlled with xanthine oxidase inhibitors at the medically appropriate dose or for
             whom these drugs are contraindicated;

          4. Willing to provide written informed consent prior to the conduct of any study specific
             procedures;

          5. Understands and is willing and able to comply with study requirements, including the
             schedule of follow-up visits

        Exclusion Criteria:

          1. Prior exposure to any experimental or marketed uricase (e.g., pegloticase
             [Krystexxa®], pegadricase [SEL-037], rasburicase [Elitek, Fasturtec]);

          2. History of anaphylaxis or severe allergic reactions to medications;

          3. History of any allergy to pegylated products

          4. Drugs known to interact with Rapamune cannot be used during the trial;

          5. Uncontrolled diabetes;

          6. Glucose-6-phosphate dehydrogenase (G6PD) deficiency;

          7. Uncontrolled hypertension;

          8. Patients whose arrhythmia is unstable on current treatment;

          9. History of coronary artery disease, including myocardial infarction or unstable
             angina, within the last 6 months;

         10. Congestive heart failure;

         11. History of hematological disorders within 1 year or autoimmune disorders, is
             immunosuppressed or immunocompromised;

         12. Has received an inactivated vaccine in the previous 3 months or has received a live
             virus vaccine in the previous 6 months;

         13. Is planning to receive any vaccination or live virus vaccination during the study;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years

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? 0