Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.

Study Overview

• Status: Completed
• Conditions: Chronic Gout Refractory to Conventional Therapy
• Intervention / Treatment: Drug: pegloticase 8 mg i.v.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago- Dept. Biological Services
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Portland Rheumatology Clinic, L.L.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previous treatment in studies of pegloticase i.v.
• Last exposure to pegloticase i.v. greater than one year prior to study entry
• Symptomatic gout
• Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria:

• Prior exposure to Elitek® (rasburicase)
• Unstable angina
• Uncontrolled arrhythmia or hypertension
• Non-compensated congestive heart failure
• End stage renal disease requiring dialysis
• Concomitant use of SUA lowering agents and use of other investigational drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pegloticase	Drug: pegloticase 8 mg i.v.; pegloticase 8 mg i.v. every 2 weeks for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Profile	Number of participants reporting events	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Plasma Uric Acid	This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.	Baseline, Week 3 and Week 7

Collaborators and Investigators

• Sponsor: Savient Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 8, 2008

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Gout; Gouty Arthritis; Anti-Gout preparations
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: C0409