Gout

​The Division of Rheumatology strives to understand more about gout through research.  Please see the list below, which summarizes the studies available to individuals interested in advancing our understanding and treatment of rheumatic disease. 

Study Name/IRB#/PI

​Brief DescriptionBasic Eligibility Criteria​Contact

A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess
Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion
Duration in Subjects with Uncontrolled Gout Receiving Methotrexate

HZNP-KRY-403

Christopher Striebich M.D., Ph.D

This study Assesses Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion
Duration in Subjects with Uncontrolled Gout Receiving Methotrexate

1. Adult men or women ≥18 years of age. 
2. Uncontrolled gout, defined as meeting the following criteria: 
• Hyperuricemia during the screening period defined as sUA ≥6 mg/dL and; 
• Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview
3. Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase infusions during the study. 
4. Able to tolerate MTX 15 mg for 4 weeks during the MTX Run-in Period prior to the first dose of pegloticase. 

Exclusion Criteria: 

1. Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (defined as 3 months or longer) would also meet exclusion criteria. 
2. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug. 
3. Known allergy to pegylated products or history of anaphylactic reaction to a recombinant protein or porcine product. 
4. Contraindication to methotrexate (MTX) treatment, MTX treatment considered inappropriate, or know intolerance to MTX. 
5. Uncontrolled hyperglycemia with a plasma glucose value >240 mg/dL at Screening that is not subsequently controlled by the end of the Screening. 
6. Non-compensated congestive heart failure or hospitalization for congestive heart failure or treatment for acute coronary syndrome (myocardial infarction or unstable angina) within 3 months of the Screening Visit, or current uncontrolled arrhythmia, or current uncontrolled BP (>160/100 mmHg) prior to Week -4. 

Chong Pedrick

303-724-0581

Chong.Pedrick@CUAnschutz.edu

Please note that study status changes frequently and therefore, a listed study may not be actively enrolling. Also, the complete list of inclusion and exclusion criteria for a given study is often not listed due to its length.  A visit to determine an individuals eligibility may be required.  A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.​