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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT06822933
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age at screening
* Patients with a clinical diagnosis of gout
* Patients who fulfil the ACR/EULAR classification criteria
* Serum urate level \>360 µmol/L at inclusion
* At least 1 gout flare in the past 12 months
* Having a smartphone/tablet
Exclusion Criteria:
* Pregnant or breastfeeding
* Contraindication for urate lowering therapy
* Comedication azatioprin or 6-mercaptopurin
* Unstable medical conditions (e.g., uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance \<45 mL/min); severe infection or gastrointestinal bleed
* Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
* Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06822933
Study Brief:
Protocol Section:
NCT06822933