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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT03664167
Eligibility Criteria:
Inclusion Criteria:
* a diagnosis of gouty arthritis per expert opinion and the ACR/EULAR 2015 criteria for gout.
* have had at least one self-reported flare in the last 12 months
* BMI \>30kg/m2
* \>18 years of age
Exclusion Criteria:
* pregnant
* hisotry or suspicion of drug abuse within the past 5 years
* Active muscle disease, cancer, previous kidney disease, and/or fatty liver
* An estimated creatinine clearance \<30 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
* An investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
* Any other medical or psychological condition which, in the opinion of the investigator and/or medical monitor, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements, or to complete the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03664167
Study Brief:
Protocol Section:
NCT03664167