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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05588908
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 Years to 65 Years, both male and female
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
* Presence of acute gout flare for no longer than 7 days
* Baseline pain intensity \> or = to 50 mm on the 0-100 mm VAS
* Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both
Exclusion Criteria:
* Secondary gout (such as gout caused by chemotherapy, transplant gout, etc.)
* Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Presence of severe renal function impairment
* Intolerance of subcutaneous and intramuscular injection
* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
* History of malignant tumor within 5 years before screening
* Live vaccinations within 3 months prior to the start of the study
* Use of forbidden therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05588908
Study Brief:
Protocol Section:
NCT05588908