Last updated on May 2020

Study of KRYSTEXXA (Pegloticase) Plus Methotrexate in Patients With Uncontrolled Gout


Brief description of study

Approximately 135 participants will be randomized. Study duration will be approximately 86 weeks.

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.

Detailed Study Description

This study is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of pegloticase with MTX vs. pegloticase with placebo for MTX in adult participants with uncontrolled gout.

Clinical Study Identifier: NCT03994731

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Rheumatic Disease Center

Glendale, WI United States
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Orchard Park, NY United States
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Birmingham, AL United States
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Denver, CO United States
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Orlando, FL United States
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Pinellas Park, FL United States
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Pompano Beach, FL United States
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Tampa, FL United States
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Florida Medical Clinic, LLC

Zephyrhills, FL United States
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MD Medical Research

Oxon Hill, MD United States
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Santa Fe Rheumatology

Santa Fe, NM United States
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Medication Management, LLC

Greensboro, NC United States
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PMG Research of Wilmington, LLC

Wilmington, NC United States
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Clinical Research Source Inc.

Perrysburg, OH United States
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Piedmont Arthritis Clinic

Greenville, SC United States
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Articularis Healthcare Group

Summerville, SC United States
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Ramesh C. Gupta, M.D.

Memphis, TN United States
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Arthritis Northwest

Spokane, WA United States
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Infusion Associates

Grand Rapids, MI United States
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Benefis Hospital

Great Falls, MT United States
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Recruitment Status: Open


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