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Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Primary Purpose

Gout

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

About this trial

This is an interventional treatment trial for Gout focused on measuring gout, chronic gout

Eligibility Criteria

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

Inclusion Criteria:

  • Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion Criteria:

  • unstable angina
  • uncontrolled arrhythmia
  • uncontrolled hypertension
  • end stage renal disease requiring dialysis
  • anemia

Sites / Locations

  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • Pacific Arthritis Center Medical Group
  • Agilence Arthritis & Osteoporosis Medical Center
  • Veterans Affairs Medical Center
  • Arthritis & Rheumatic Disease Specialties
  • Ocala Rheumatology Research Center
  • St. Petersburg Arthritis Center
  • The University of Chicago
  • Graves Gilbert Clinic
  • Peter A. Holt, M.D.
  • Center for Rheumatology and Bone Research
  • Justus J. Fiechtner, MD, PC
  • CentraCare Clinic
  • Rheumatology Associates of North Jersey
  • Duke University Medical Center
  • New Horizons Clinical Research
  • The Ohio State University
  • STAT Research, Inc.
  • David R. Mandel, MD, Inc.
  • Altoona Center for Clinical Research
  • Mid Atlantic Research Assoc.
  • Arthritis Northwest, PLLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

q2 RCT

q4 RCT

Placebo in RCT

Arm Description

Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study

Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE

Outcomes

Primary Outcome Measures

Uric Acid (mg/dL)
Uric acid measured at 3 month-intervals

Secondary Outcome Measures

Tophus Response
Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.
Patient Reported Outcome: SF-36 Physical Component Summary Score
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.
Gout Flare Frequency
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
Gout Flare Incidence
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.

Full Information

First Posted
October 27, 2008
Last Updated
October 28, 2011
Sponsor
Savient Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01356498
Brief Title
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Official Title
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Savient Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
gout, chronic gout

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
q2 RCT
Arm Type
Experimental
Arm Description
Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
Arm Title
q4 RCT
Arm Type
Experimental
Arm Description
Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
Arm Title
Placebo in RCT
Arm Type
Experimental
Arm Description
Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
Intervention Type
Biological
Intervention Name(s)
pegloticase
Intervention Description
8 mg intravenous infusion
Primary Outcome Measure Information:
Title
Uric Acid (mg/dL)
Description
Uric acid measured at 3 month-intervals
Time Frame
Week 13, Week 25, Week 53, Week 101
Secondary Outcome Measure Information:
Title
Tophus Response
Description
Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.
Time Frame
Up to 2 years
Title
Patient Reported Outcome: SF-36 Physical Component Summary Score
Description
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.
Time Frame
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
Title
Gout Flare Frequency
Description
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
Time Frame
Up to 2 years
Title
Gout Flare Incidence
Description
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
Time Frame
Assessed in 3-month intervals up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout Exclusion Criteria: unstable angina uncontrolled arrhythmia uncontrolled hypertension end stage renal disease requiring dialysis anemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, M.D.
Organizational Affiliation
Savient Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Medical Center, Clinical Trials Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Agilence Arthritis & Osteoporosis Medical Center
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
St. Petersburg Arthritis Center
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Peter A. Holt, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Justus J. Fiechtner, MD, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
CentraCare Clinic
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Rheumatology Associates of North Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27302
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
David R. Mandel, MD, Inc.
City
Mayfield Village
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Mid Atlantic Research Assoc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19154
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31203212
Citation
Pillinger MH, Fields TR, Yeo AE, Lipsky PE. Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase. J Rheumatol. 2020 Apr;47(4):605-612. doi: 10.3899/jrheum.190161. Epub 2019 Jun 15.
Results Reference
derived
PubMed Identifier
24588936
Citation
Lipsky PE, Calabrese LH, Kavanaugh A, Sundy JS, Wright D, Wolfson M, Becker MA. Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout. Arthritis Res Ther. 2014 Mar 4;16(2):R60. doi: 10.1186/ar4497.
Results Reference
derived
PubMed Identifier
24286509
Citation
Baraf HS, Becker MA, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, Rehrig CD, Ottery FD, Sundy JS, Yood RA. Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy. Arthritis Res Ther. 2013 Sep 26;15(5):R137. doi: 10.1186/ar4318.
Results Reference
derived

Learn more about this trial

Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

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