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Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

Primary Purpose

Gout

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

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

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

Inclusion Criteria: Outpatients of either gender, age 18 or older ( no upper age limit). Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL. Patient has symptomatic gout (presence of at least 3 gout flares in the 18 months prior to entry, or at least one gout tophus, or gouty arthritis). Conventional therapy is contraindicated or has been ineffective in this patient, i.e., patient has a history (either by medical record or patient interview) of hypersensitivity or of failure to normalize SUA with at least 3 months treatment with allopurinol at the maximum labeled dose (800 mg/dL in the U.S.), or at a medically appropriate lower dose based on dose-limiting toxicity or dose-limiting co-morbidity. Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including washout). If the patient is a woman of childbearing potential, she must have had a negative screening serum pregnancy test and must use a medically approved form of birth control during her participation in the protocol. Such methods include oral, injectable or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide. (If male or surgically sterile, check N/A.) Exclusion Criteria: The patient has unstable angina. The patient has uncontrolled arrhythmia. The patient has non-compensated congestive heart failure. The patient has uncontrolled hypertension (above 150/95). The patient has a history of end stage renal disease requiring dialysis. The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females). The patient is an organ transplant recipient The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or any concomitant therapy with a PEG-conjugated drug. The patient has had a gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis). The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient has a history of anaphylactic reaction to a recombinant protein or porcine product, or hypersensitivity to PEG. The patient is pregnant or breast feeding. The patient has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study. The patient has a known allergy to urate oxidase or PEGylated products. The patient has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Sites / Locations

  • UAB Arthritis Clinical Intervention Program
  • University of Arizona Arthritis Center
  • NEA Clinic
  • UCSD Rheumatology Division
  • Kaiser Permanente Medical Center, Clinical Trials Unit
  • Pacific Arthritis Center Medical Group
  • E. Robert Harris Medical Corporation
  • Agilence Arthritis & Osteoporosis Medical Center
  • Arthritis Associates & Osteoporosis Center of Colorado Springs
  • Veterans Affairs Medical Center
  • Arthritis & Rheumatic Disease Specialties
  • Malcom Randall VA Medical Center
  • Horizon Institute for Clinical Research
  • Ocala Rheumatology Research Center
  • Arthritis & Osteoporosis Treatment Center, PA
  • St. Petersburg Arthritis Center
  • Idaho Arthritis & Osteoporosis Center
  • Institute of Arthritis Research
  • The University of Chicago
  • Graves Gilbert Clinic
  • Peter A. Holt, M.D.
  • Malamet & Klein, MD, PA
  • The Center for Rheumatology and Bone Research
  • Fallon Clinic, Inc
  • Michigan Arthritis Research Center
  • Justus J. Fiechtner, MD, PC
  • Mayo Clinic
  • CentraCare Clinic
  • Rheumatology Associates of North Jersey
  • Mount Sinai Medical Center
  • Duke University Medical Center
  • Brody School of Medicine, East Carolina University
  • Physicians East, P.A.
  • Carolina Atthritis Associates
  • New Horizons Clinical Research
  • The Cleveland Clinic Foundation
  • The Ohio State University
  • STAT Research, Inc.
  • David R. Mandel, MD, Inc.
  • Health Research of Oklahoma
  • Portland Medical Associates
  • Altoona Center for Clinical Research
  • Mid Atlantic Research Assoc.
  • Rheumatology Associates
  • Piedmont Arthritis, PA
  • AAMR Research Clinic
  • Arthritis & Osteoporosis Center of South Texas
  • Arthritis & Osteoporosis Clinic Research Center of Central Texas
  • Arthritis Northwest, PLLC
  • Rheumatic Disease Center
  • Manitoba Clinic
  • St. Joseph's Health Care
  • Clinica para el Diagnostico y Tratamiento de las Enfermedades Rheumaticas
  • Hospital General de mexico
  • Antiguo Hospital Civil de Guadalajara
  • Hospital Civil de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

q2 wks

q4 wks

placebo

Arm Description

8 mg pegloticase every 2 weeks

8 mg pegloticase every 4 weeks (alternating with placebo every 4 weeks)

placebo every 2 weeks

Outcomes

Primary Outcome Measures

Plasma Uric Acid (PUA) Responder
PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.

Secondary Outcome Measures

Reduction in Tophus Burden
percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.
Percentage of Subjects With Gout Flare Per 3-month Period
Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.
Change in Number of Swollen Joints
Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.
Change in Number of Tender Joints
Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant
Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.

Full Information

First Posted
May 10, 2006
Last Updated
February 24, 2011
Sponsor
Savient Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00325195
Brief Title
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
Official Title
Randomized, Multicenter, Double-blind, Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Savient Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.
Detailed Description
The primary objective of each of the studies is to demonstrate superiority in the response rate (control of uric acid levels to below 6 mg/dL) in the PEG-uricase treatment groups compared to the placebo-control group. While reduction or resolution of tophi have been reported in the setting of prolonged urate-lowering therapy, there is photographic and additional anecdotal evidence from the Phase 2 PEG-uricase study of resolution or significant reduction of tophi after 3 months of therapy. Therefore, an assessment of changes in tophi over time will be conducted through the use of digital photographs obtained in a standardized manner from all subjects during the study. The effect on other clinical outcomes, including quality of life, health-related disability measures, gout flares and the number of swollen and tender joints will also be compared between the treatment groups and control group. Subjects will be randomized to one of the three treatment arms in a 2:2:1 ratio: 8 mg PEG-uricase every 2 weeks; 8 mg PEG-uricase every 4 weeks; or placebo. All subjects will receive an intravenous infusion (PEG-uricase or placebo) every two weeks in order to maintain the blind throughout the study. Study duration is approximately 26 weeks, including two weeks for screening and 24 weeks (6 months) of treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
q2 wks
Arm Type
Experimental
Arm Description
8 mg pegloticase every 2 weeks
Arm Title
q4 wks
Arm Type
Experimental
Arm Description
8 mg pegloticase every 4 weeks (alternating with placebo every 4 weeks)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo every 2 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo by intravenous infusion every 2 weeks
Intervention Type
Biological
Intervention Name(s)
pegloticase
Other Intervention Name(s)
PEG-uricase, Puricase
Intervention Description
8 mg pegloticase by intravenous infusion
Primary Outcome Measure Information:
Title
Plasma Uric Acid (PUA) Responder
Description
PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.
Time Frame
Months 3 and 6
Secondary Outcome Measure Information:
Title
Reduction in Tophus Burden
Description
percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.
Time Frame
Baseline and Final Visit (6 months or LOCF)
Title
Percentage of Subjects With Gout Flare Per 3-month Period
Description
Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.
Time Frame
Months 1-3 and Months 4-6
Title
Change in Number of Swollen Joints
Description
Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.
Time Frame
Baseline and Final Visit (Month 6 or LOCF)
Title
Change in Number of Tender Joints
Description
Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant
Time Frame
Baseline and Final Visit (Month 6 or LOCF)
Title
Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
Description
Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.
Time Frame
Baseline to Final Visit (Month 6 or LOCF)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients of either gender, age 18 or older ( no upper age limit). Patient is hyperuricemic: screening serum uric acid must be ≥8 mg/dL. Patient has symptomatic gout (presence of at least 3 gout flares in the 18 months prior to entry, or at least one gout tophus, or gouty arthritis). Conventional therapy is contraindicated or has been ineffective in this patient, i.e., patient has a history (either by medical record or patient interview) of hypersensitivity or of failure to normalize SUA with at least 3 months treatment with allopurinol at the maximum labeled dose (800 mg/dL in the U.S.), or at a medically appropriate lower dose based on dose-limiting toxicity or dose-limiting co-morbidity. Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including washout). If the patient is a woman of childbearing potential, she must have had a negative screening serum pregnancy test and must use a medically approved form of birth control during her participation in the protocol. Such methods include oral, injectable or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide. (If male or surgically sterile, check N/A.) Exclusion Criteria: The patient has unstable angina. The patient has uncontrolled arrhythmia. The patient has non-compensated congestive heart failure. The patient has uncontrolled hypertension (above 150/95). The patient has a history of end stage renal disease requiring dialysis. The patient has hemoglobin < 8 g/dL (males) or < 7 g/dL (females). The patient is an organ transplant recipient The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or any concomitant therapy with a PEG-conjugated drug. The patient has had a gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis). The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient has a history of anaphylactic reaction to a recombinant protein or porcine product, or hypersensitivity to PEG. The patient is pregnant or breast feeding. The patient has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study. The patient has a known allergy to urate oxidase or PEGylated products. The patient has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Savient Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UAB Arthritis Clinical Intervention Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Arizona Arthritis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
UCSD Rheumatology Division
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0943
Country
United States
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
E. Robert Harris Medical Corporation
City
Whittier
State/Province
California
ZIP/Postal Code
90601
Country
United States
Facility Name
Agilence Arthritis & Osteoporosis Medical Center
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Arthritis Associates & Osteoporosis Center of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
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
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Horizon Institute for Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Arthritis & Osteoporosis Treatment Center, PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
St. Petersburg Arthritis Center
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Idaho Arthritis & Osteoporosis Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83401
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
Malamet & Klein, MD, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
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
Fallon Clinic, Inc
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Michigan Arthritis Research Center
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Facility Name
Justus J. Fiechtner, MD, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27302
Country
United States
Facility Name
Brody School of Medicine, East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Physicians East, P.A.
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Carolina Atthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
Facility Name
Portland Medical Associates
City
Portland
State/Province
Oregon
ZIP/Postal Code
97224
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
Rheumatology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Piedmont Arthritis, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
AAMR Research Clinic
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Arthritis & Osteoporosis Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic Research Center of Central Texas
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Clinica para el Diagnostico y Tratamiento de las Enfermedades Rheumaticas
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Hospital General de mexico
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Antiguo Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
Country
Mexico

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
31079535
Citation
Johnson RJ, Choi HK, Yeo AE, Lipsky PE. Pegloticase Treatment Significantly Decreases Blood Pressure in Patients With Chronic Gout. Hypertension. 2019 Jul;74(1):95-101. doi: 10.1161/HYPERTENSIONAHA.119.12727. Epub 2019 May 13.
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
24447425
Citation
Yood RA, Ottery FD, Irish W, Wolfson M. Effect of pegloticase on renal function in patients with chronic kidney disease: a post hoc subgroup analysis of 2 randomized, placebo-controlled, phase 3 clinical trials. BMC Res Notes. 2014 Jan 21;7:54. doi: 10.1186/1756-0500-7-54.
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
PubMed Identifier
21846852
Citation
Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

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