Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

NCT01466166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2019-01-11

Study results available
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Summary

The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.

Conditions

  • Refractory Chronic Gout

Interventions

BIOLOGICAL

Pegloticase

Pegloticase 8 mg intravenous every 2 weeks

Sponsors & Collaborators

  • Horizon Pharma Rheumatology LLC

    lead INDUSTRY

Principal Investigators

  • Jeffery Nieves, PharmD · Horizon Pharma Rheumatology LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-15
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466166 on ClinicalTrials.gov