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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT01356602
Eligibility Criteria:
Inclusion criteria:
* 3 or more gout flares within last year
* Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
* Body mass index of less than or equal to 45 kg/m2
Exclusion criteria:
* Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
* Hemodialysis
* Live vaccine within 3 months before first dose
* Donation or loss of 400 mL or more within 3 months before first dose
* Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
* Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
* Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
* Significant cardiovascular conditions such as uncontrolled hypertension
* Significant medical diseases such as uncontrolled diabetes, thyroid disease
* History of malignancy of any organ system within the past 5 years
* Women who are pregnant or nursing
* Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01356602
Study Brief:
Protocol Section:
NCT01356602