Open-Label Extension Study for Patients Who Completed a P... | NCT01356498 | Trialant
NCT01356498
Sponsor
Savient Pharmaceuticals
Status
Completed
Last Update Posted
Dec 2, 2011Estimated
Enrollment
151Actual
Phase
Phase 3
Conditions
Gout
Interventions
pegloticase
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01356498
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C0407
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
Savient PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Oct 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2006
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
First Submitted Date
Oct 27, 2008
First Submission Date that Met QC Criteria
May 18, 2011
First Posted Date
May 19, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 5, 2011
Results First Submitted that Met QC Criteria
Oct 28, 2011
Results First Posted Date
Dec 2, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 28, 2011
Last Update Posted Date
Dec 2, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Savient PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Gout
Keywords
gout
chronic gout
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
151Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
q2 RCT
Experimental
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
Biological: pegloticase
q4 RCT
Experimental
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
Biological: pegloticase
Placebo in RCT
Experimental
Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
Biological: pegloticase
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pegloticase
Biological
8 mg intravenous infusion
Placebo in RCT
q2 RCT
q4 RCT
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Uric Acid (mg/dL)
Uric acid measured at 3 month-intervals
Week 13, Week 25, Week 53, Week 101
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director, M.D.
Savient Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Kaiser Permanente Medical Center, Clinical Trials Unit
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants made the decision, along with the treating investigator, of which dose to receive in this study while remaining blinded to treatment received and results during the RCT. Cohort designations are based on participants' initial RCT treatment and whether uric acid remained <6 mg/dL for 80% of the time during months 3 and 6 in the RCT.
Recruitment Details
Subjects completing one of the randomized, controlled Phase 3 clinical trials (RCTs) of pegloticase [C0405 and C0406 (NCT00325195)] were invited to participate in this open-label extension study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
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.
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
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
Up to 2 years
Gout Flare Incidence
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
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.
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
FG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
FG003
q2 RCT, Non-responder
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
FG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
FG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
FG00035 subjects
FG00125 subjects2 other patients received no investigational drug in C0407 but elected to be followed in Observation
FG00223 subjects
FG00322 subjects
FG00428 subjects
FG00516 subjects
COMPLETED
FG00024 subjects
FG00117 subjects
FG00211 subjects
FG0038 subjects
FG0048 subjects
FG0052 subjects
NOT COMPLETED
FG00011 subjects
FG0018 subjects
FG00212 subjects
FG00314 subjects
FG00420 subjects
FG00514 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
BG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
BG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
BG003
q2 RCT, Non-responder
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
BG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
BG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00125
BG00223
BG00322
BG00428
BG00516
BG006149
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.4± 13.66
BG00158.6± 13.59
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0017
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00032
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Uric Acid (mg/dL)
Uric acid measured at 3 month-intervals
ITT
Posted
Mean
Standard Deviation
mg/dL
Week 13, Week 25, Week 53, Week 101
ID
Title
Description
OG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
OG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
OG003
q2 RCT, Non-responder
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Units
Counts
Participants
OG00031
OG00124
OG00218
OG003
Title
Denominators
Categories
OLE Week 13
Title
Measurements
OG0001.33± 3.103
OG0011.91± 4.082
OG0025.06± 4.538
OG003
Secondary
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.
ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.
Posted
Number
participants
Up to 2 years
ID
Title
Description
OG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
OG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
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.
Number of participants was the subset of the ITT population with SF-36 baseline data
Posted
Mean
Standard Deviation
units on a scale
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
ID
Title
Description
OG000
q2 RCT, Responder
Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
OG001
q4 RCT Responder
REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
OG002
Placebo in RCT, q2 in OLE
Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
Secondary
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
Analysis is based on ITT population, and is presented by intervals of time on pegloticase
Posted
Mean
Standard Deviation
Flares
Up to 2 years
ID
Title
Description
OG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
OG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
OG003
q2 RCT, Non-responder
Secondary
Gout Flare Incidence
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.
Posted
Number
Percentage of participants
Assessed in 3-month intervals up to 2 years
ID
Title
Description
OG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
OG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
OG003
q2 RCT, Non-responder
Time Frame
Up to 30 days post-treatment (maximum of 32 months)
Description
Serious Adverse Events are reported for subjects during the On-pegloticase period, and includes events reported through 30 days after the last exposure to pegloticase.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
q2 RCT, Responder
Responder in 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 Extension (OLE) study
9
35
34
35
EG001
q4 RCT, Responder
Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
7
25
25
25
EG002
Placebo in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
8
23
23
23
EG003
q2 RCT, Non-responder
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
7
22
21
22
EG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
12
28
28
28
EG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
8
16
15
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infusion related reaction
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0024 affected23 at risk
EG0031 affected22 at risk
EG0043 affected28 at risk
EG0053 affected16 at risk
Chest pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Asthenia
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Arthritis Bacterial
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Sepsis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Gout
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Gouty Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Renal Failure Chronic
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Azotemia
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0022 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Diverticular Performation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Femoral Artery Occlusion
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Hypotension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Syncope
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Nasal Septum Deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Fluid Overload
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Depression
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Stress
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Goitre
Endocrine disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Glaucoma
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Myeloproliferative Disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Skin Necrosis
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0020 affected23 at risk
EG003
Inguinal Hernia Repair
Surgical and medical procedures
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected25 at risk
EG0020 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gout
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
Preferred Term 'Gout' includes the preferred term for lower level term 'gout flare'
EG00015 affected35 at risk
EG00119 affected25 at risk
EG00219 affected23 at risk
EG00316 affected22 at risk
EG004
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0017 affected25 at risk
EG0026 affected23 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0005 affected35 at risk
EG0018 affected25 at risk
EG0024 affected23 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0005 affected35 at risk
EG0014 affected25 at risk
EG0029 affected23 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0014 affected25 at risk
EG0021 affected23 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Shoulder Pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Upper Respiratory Tract Invection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0008 affected35 at risk
EG0018 affected25 at risk
EG0024 affected23 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0015 affected25 at risk
EG0022 affected23 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0015 affected25 at risk
EG0021 affected23 at risk
EG003
Sinusitits
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0004 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0011 affected25 at risk
EG0022 affected23 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0006 affected35 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected25 at risk
EG0023 affected23 at risk
EG003
Influenza
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0013 affected25 at risk
EG0021 affected23 at risk
EG003
Localised Infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0011 affected25 at risk
EG0023 affected23 at risk
EG003
Infusion Related Reaction
General disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0016 affected25 at risk
EG00213 affected23 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0016 affected25 at risk
EG0025 affected23 at risk
EG003
Fatigue
General disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0013 affected25 at risk
EG0025 affected23 at risk
EG003
Chest Pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected25 at risk
EG0022 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected35 at risk
EG0016 affected25 at risk
EG0023 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0015 affected25 at risk
EG0022 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0013 affected25 at risk
EG0021 affected23 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0011 affected25 at risk
EG0023 affected23 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0012 affected25 at risk
EG0022 affected23 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0014 affected25 at risk
EG0022 affected23 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0013 affected25 at risk
EG0022 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0013 affected25 at risk
EG0022 affected23 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0010 affected25 at risk
EG0021 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0008 affected35 at risk
EG0012 affected25 at risk
EG0023 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Headache
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected35 at risk
EG0015 affected25 at risk
EG0024 affected23 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0013 affected25 at risk
EG0020 affected23 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected35 at risk
EG0012 affected25 at risk
EG0023 affected23 at risk
EG003
Flushing
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0013 affected25 at risk
EG0021 affected23 at risk
EG003
Hypotension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected25 at risk
EG0021 affected23 at risk
EG003
Cataract
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0013 affected25 at risk
EG0021 affected23 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0010 affected25 at risk
EG0022 affected23 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected35 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Depression
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected25 at risk
EG0021 affected23 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Savient Pharmaceuticals, Inc.
732-418-9300
ID
Term
D006073
Gout
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D000070657
Crystal Arthropathies
D012216
Rheumatic Diseases
D011686
Purine-Pyrimidine Metabolism, Inborn Errors
D008661
Metabolism, Inborn Errors
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C031545
Pegloticase
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG00020
BG00117
BG00218
BG00316
BG00423
BG00511
BG006105
>=65 years
BG00015
BG0018
BG0025
BG0036
BG0045
BG0055
BG00644
56.6
± 10.53
BG00352.0± 13.12
BG00453.5± 12.25
BG00554.6± 13.62
BG00656.8± 13.19
4
BG0034
BG0044
BG0053
BG00632
Male
BG00025
BG00118
BG00219
BG00318
BG00424
BG00513
BG006117
22
BG00317
BG00427
BG00513
BG006133
Canada
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0040
BG0050
BG0062
Mexico
Title
Measurements
BG0003
BG0012
BG0020
BG0035
BG0041
BG0053
BG00614
17
OG00422
OG00510
9.76
± 1.346
OG0049.66± 2.529
OG0058.08± 3.561
OLE Week 25
Title
Measurements
OG0001.4± 3.196
OG0011.95± 3.761
OG0024.69± 4.454
OG0038.89± 3.984
OG0049.94± 2.646
OG0058.09± 3.536
OLE Week 53
Title
Measurements
OG0000.87± 2.327
OG0011.55± 3.690
OG0022.7± 4.255
OG0039.18± 2.946
OG0049.59± 2.782
OG0056.45± 3.248
OLE Week 101
Title
Measurements
OG0000.84± 2.619
OG0011.47± 3.317
OG0024.29± 3.985
OG0037.7± 4.244
OG0049.42± 1.961
OG0058.5± NAOne subject only
OG003
q2 RCT, Non-responder
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Units
Counts
Participants
OG00023
OG00114
OG00216
OG00316
OG00420
OG0055
Title
Denominators
Categories
Complete Response
Title
Measurements
OG00019
OG00113
OG00210
OG0034
OG0047
OG0053
Partial Response
Title
Measurements
OG0004
OG0010
OG0023
OG003
OG003
q2 RCT, Non-responder
Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
OG004
q4 RCT, Non-responder
Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
OG005
Placebo in RCT, q4 in OLE
Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
Units
Counts
Participants
OG00034
OG00125
OG00223
OG00319
OG00426
OG00515
Title
Denominators
Categories
Baseline value (pre-pegloticase)
Title
Measurements
OG00034.92± 10.988
OG00134.11± 10.022
OG00227.55± 11.405
OG00333.71± 11.581
OG00432.8± 10.129
OG00536.2± 11.926
Final Visit value (LOCF)
Title
Measurements
OG00040.40± 13.393
OG00140.82± 7.482
OG00230.34± 11.132
OG003
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Units
Counts
Participants
OG00035
OG00125
OG00223
OG00322
OG00428
OG00516
Title
Denominators
Categories
Months 1-3
Title
Measurements
OG0000.4± 0.69
OG0010.8± 0.90
OG0022.3± 2.91
OG0030.6± 0.90
OG0041.3± 1.49
OG0051.5± 1.41
Months 4-6
Title
Measurements
OG0000.4± 0.96
OG0010.7± 0.95
OG0021.3± 2.17
OG003
Months 7-9
Title
Measurements
OG0000.0± 0.17
OG0010.3± 0.54
OG0021.2± 1.80
OG003
Months 10-12
Title
Measurements
OG0000.1± 0.30
OG0010.2± 0.51
OG0020.6± 1.18
OG003
Months 16-18
Title
Measurements
OG0000.1± 0.25
OG001.3± 0.44
OG0020.2± 0.40
OG003
Months 22-24
Title
Measurements
OG0000.1± 0.37
OG0010.1± 0.23
OG0020.4± 0.67
OG003
Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG004
q4 RCT Non-responder
Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
OG005
Placebo in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study