Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT00111657
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Symptomatic gout
* Serum uric acid \>7 mg/dL
* Intolerance of, or inadequate response to, conventional therapy for gout
* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method
Exclusion Criteria:
* End stage renal failure that requires dialysis
* Concurrent use of uric-acid lowering agents
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* A history of anaphylactic reaction to a recombinant protein
* Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)
* A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00111657
Study Brief:
Protocol Section:
NCT00111657