Clinical trial: Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid (NCT02959918)

Eligibility criteria:
Inclusion Criteria:

          1. Adult (age 21-75 inclusive) men and women of non child bearing potential with
             established or symptomatic gout which is defined as having at least ONE of any of the
             3 following factors:

               1. ≥ 1 tophus

               2. 1 gout flare within the last 6 months

               3. Chronic gouty arthropathy

          2. Screening serum uric acid of >6ng/dL

          3. On a gout flare prophylactic regimen for 7 days prior to first dose

          4. Willing to provide written informed consent prior to first study procedure is
             performed.

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

        Exclusion Criteria:

          1. History of anaphylaxis or severe allergic reaction.

          2. History of an allergy to pegylated products.

          3. Women of child bearing potential, Defined as:

               -  <6 weeks after surgical bilateral salpingooperhectony with or without
                  hysterectomy

               -  Pre or perimenopausal ( < less than 24 months of natural amenorrhea)

          4. Initiation or change in dose of hormone-replacement therapy for menopausal women less
             than 1 month prior to the Screening Visit or during the Screening Phase would be
             exclusionary. If after being on a stable dose of hormone-replacement therapy for one
             month the patient may be considered for the study if she continues to meet all other
             inclusion and exclusion criteria

          5. Uncontrolled diabetes with baseline HbA1c ≥8%;

          6. Glucose-6-phosphate dehydrogenase deficiency;

          7. Uncontrolled hypertension

          8. Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;

          9. History of coronary artery disease, including myocardial infarction;

         10. Congestive heart failure, New York Heart Association Class III or IV;

         11. ECG with evidence of prior myocardial infarction, clinically significant arrhythmia,
             or other abnormalities that, in the opinion of the investigator, are consistent with
             significant underlying cardiac disease;

         12. History of hematological or autoimmune disorders, is immunosuppressed or
             immunocompromised;

         13. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek,
             Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)

         14. History of malignancy within the last 5 years other than basal skin cancer;

         15. Subjects who, in the opinion of the investigator, present with a condition that would
             compromise their safety or that would make study completion unlikely.
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 75 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? Contradiction