Summary:
A multicenter, randomized, double-blind, phase 2 study to evaluate the effect of an investigational medication in joint damage in hyperuricemic subjects with early gout.
Qualified Participants Must:
• Have a history or presence of gout defined as having one or more of the following conditions of the American Rheumatism Association (ARA) preliminary criteria for the diagnosis of gout.
- A tophus proven to contain urate crystals by chemical or polarized light microscopic means
and/or
- Characteristic urate crystals in the joint fluid and/or
- History of at least 6 of the following clinical, laboratory and x-ray phenomena*:
maximum inflammation developed within 1 day
monoarticular arthritis
redness observed over joints
first metatarsophalangeal joint painful or swollen
unilateral first metatarsophalangeal joint attack
unilateral tarsal joint attack
tophus (proven or suspected)
hyperuricemia
asymmetric swelling within a joint on x-ray
sub-cortical cysts without erosions on x-ray
joint fluid culture negative for organisms during attacks
•
Have more than one flare criteria that has been excluded for the purpose of this study
•
If male, be at least 18 years of age
•
If female, be 45 years of age or older and be at least 2 years post-menopausal AND have a Follicle Stimulating Hormone (FSH) level ≥40IU/L OR
•
If female and receiving hormone replacement therapy (HRT), be ≥55 years of age (FSH level not required)
•
Have hyperuricemia defined as sUA level ≥7.0 mg/dL at screening
•
Have a history of (one) single acute gout flare located within right or left MTP, IP, ankle, MCP, PIP, or DIP joints prior to screening
Qualified Participants May Receive:
All study related medication and healthcare at no cost. Eligible participants will be compensated for their time and travel.