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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00798369
Eligibility Criteria:
Inclusion Criteria:
* History of at least 1 gout flare prior to the Screening Visit
* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
* Presence of acute gout flare for no longer than 5 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:
* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
* Presence of severe renal function impairment
* Contraindication to intramuscular injection
* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
* Evidence of active pulmonary disease
* Live vaccinations within 3 months prior to the start of the study
* Use of forbidden therapy
Other protocol-defined inclusion/exclusion criteria applied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00798369
Study Brief:
Protocol Section:
NCT00798369