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

Primary Purpose

Chronic Gout Refractory to Conventional Therapy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pegloticase 8 mg i.v.
Sponsored by
Savient Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Gout Refractory to Conventional Therapy focused on measuring Gout, Gouty Arthritis, Anti-Gout preparations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago- Dept. Biological Services
  • The Center for Rheumatology and Bone Research
  • Duke University Medical Center
  • Portland Rheumatology Clinic, L.L.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pegloticase

Arm Description

Outcomes

Primary Outcome Measures

Adverse Event Profile
Number of participants reporting events

Secondary Outcome Measures

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.

Full Information

First Posted
May 6, 2008
Last Updated
June 7, 2011
Sponsor
Savient Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00675103
Brief Title
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Savient Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gout Refractory to Conventional Therapy
Keywords
Gout, Gouty Arthritis, Anti-Gout preparations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pegloticase
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pegloticase 8 mg i.v.
Intervention Description
pegloticase 8 mg i.v. every 2 weeks for 24 weeks
Primary Outcome Measure Information:
Title
Adverse Event Profile
Description
Number of participants reporting events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Plasma Uric Acid
Description
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.
Time Frame
Baseline, Week 3 and Week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Chicago- Dept. Biological Services
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Portland Rheumatology Clinic, L.L.C.
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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