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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01356498
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
Savient Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Intervention Biological: pegloticase
Enrollment 151
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.
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.
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Period Title: Overall Study
Started 35 25 [1] 23 22 28 16
Completed 24 17 11 8 8 2
Not Completed 11 8 12 14 20 14
[1]
2 other patients received no investigational drug in C0407 but elected to be followed in Observation
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE Total
Hide Arm/Group Description 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study Total of all reporting groups
Overall Number of Baseline Participants 35 25 23 22 28 16 149
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 25 participants 23 participants 22 participants 28 participants 16 participants 149 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  57.1%
17
  68.0%
18
  78.3%
16
  72.7%
23
  82.1%
11
  68.8%
105
  70.5%
>=65 years
15
  42.9%
8
  32.0%
5
  21.7%
6
  27.3%
5
  17.9%
5
  31.3%
44
  29.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 25 participants 23 participants 22 participants 28 participants 16 participants 149 participants
62.4  (13.66) 58.6  (13.59) 56.6  (10.53) 52.0  (13.12) 53.5  (12.25) 54.6  (13.62) 56.8  (13.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 25 participants 23 participants 22 participants 28 participants 16 participants 149 participants
Female
10
  28.6%
7
  28.0%
4
  17.4%
4
  18.2%
4
  14.3%
3
  18.8%
32
  21.5%
Male
25
  71.4%
18
  72.0%
19
  82.6%
18
  81.8%
24
  85.7%
13
  81.3%
117
  78.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 35 participants 25 participants 23 participants 22 participants 28 participants 16 participants 149 participants
United States 32 22 22 17 27 13 133
Canada 0 1 1 0 0 0 2
Mexico 3 2 0 5 1 3 14
1.Primary Outcome
Title Uric Acid (mg/dL)
Hide Description Uric acid measured at 3 month-intervals
Time Frame Week 13, Week 25, Week 53, Week 101
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description:
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Overall Number of Participants Analyzed 31 24 18 17 22 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
OLE Week 13 1.33  (3.103) 1.91  (4.082) 5.06  (4.538) 9.76  (1.346) 9.66  (2.529) 8.08  (3.561)
OLE Week 25 1.4  (3.196) 1.95  (3.761) 4.69  (4.454) 8.89  (3.984) 9.94  (2.646) 8.09  (3.536)
OLE Week 53 0.87  (2.327) 1.55  (3.690) 2.7  (4.255) 9.18  (2.946) 9.59  (2.782) 6.45  (3.248)
OLE Week 101 0.84  (2.619) 1.47  (3.317) 4.29  (3.985) 7.7  (4.244) 9.42  (1.961) 8.5 [1]   (NA)
[1]
One subject only
2.Secondary Outcome
Title Tophus Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description:
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Overall Number of Participants Analyzed 23 14 16 16 20 5
Measure Type: Number
Unit of Measure: participants
Complete Response 19 13 10 4 7 3
Partial Response 4 0 3 4 2 1
3.Secondary Outcome
Title Patient Reported Outcome: SF-36 Physical Component Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants was the subset of the ITT population with SF-36 baseline data
Arm/Group Title q2 RCT, Responder q4 RCT Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT, Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description:
Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
Overall Number of Participants Analyzed 34 25 23 19 26 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline value (pre-pegloticase) 34.92  (10.988) 34.11  (10.022) 27.55  (11.405) 33.71  (11.581) 32.8  (10.129) 36.2  (11.926)
Final Visit value (LOCF) 40.40  (13.393) 40.82  (7.482) 30.34  (11.132) 37.68  (10.298) 34.76  (11.413) 38.8  (13.155)
4.Secondary Outcome
Title Gout Flare Frequency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on ITT population, and is presented by intervals of time on pegloticase
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description:
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Overall Number of Participants Analyzed 35 25 23 22 28 16
Mean (Standard Deviation)
Unit of Measure: Flares
Months 1-3 0.4  (0.69) 0.8  (0.90) 2.3  (2.91) 0.6  (0.90) 1.3  (1.49) 1.5  (1.41)
Months 4-6 0.4  (0.96) 0.7  (0.95) 1.3  (2.17) 1.0  (1.73) 0.8  (0.94) 0.8  (1.18)
Months 7-9 0.0  (0.17) 0.3  (0.54) 1.2  (1.80) 0.6  (1.20) 0.6  (0.97) 0.4  (1.01)
Months 10-12 0.1  (0.30) 0.2  (0.51) 0.6  (1.18) 0.9  (1.34) 0.9  (1.46) 0.4  (0.63)
Months 16-18 0.1  (0.25) .3  (0.44) 0.2  (0.40) 0.7  (1.18) 0.6  (0.85) 0.4  (0.89)
Months 22-24 0.1  (0.37) 0.1  (0.23) 0.4  (0.67) 0.3  (0.65) 0.6  (0.53) 0.7  (1.15)
5.Secondary Outcome
Title Gout Flare Incidence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description:
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
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
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
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
Overall Number of Participants Analyzed 35 25 23 22 28 16
Measure Type: Number
Unit of Measure: Percentage of participants
Months 1-3 25.7 56.0 65.2 45.5 67.9 68.8
Months 4-6 23.5 40.0 45.0 35.0 50.0 38.5
Months 7-9 3.0 24.0 43.8 27.8 42.9 22.2
Months 10-12 9.4 16.7 28.6 47.1 45.0 28.6
Months 16-18 6.5 25.0 18.2 33.3 38.9 20.0
Months 22-24 3.4 5.3 27.3 25.0 55.6 33.3
Time Frame Up to 30 days post-treatment (maximum of 32 months)
Adverse Event Reporting 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.
 
Arm/Group Title q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Hide Arm/Group Description 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study 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 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 Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
All-Cause Mortality
q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/35 (25.71%)   7/25 (28.00%)   8/23 (34.78%)   7/22 (31.82%)   12/28 (42.86%)   8/16 (50.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Cardiac disorders             
Cardiac Failure Congestive † 1  1/35 (2.86%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Myocardial Infarction † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Endocrine disorders             
Goitre † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Eye disorders             
Glaucoma † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders             
Diarrhoea † 1  0/35 (0.00%)  1/25 (4.00%)  2/23 (8.70%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Vomiting † 1  0/35 (0.00%)  1/25 (4.00%)  1/23 (4.35%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Constipation † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Diverticular Performation † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Gastrointestinal Haemorrhage † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Peritonitis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
General disorders             
Infusion related reaction † 1  1/35 (2.86%)  0/25 (0.00%)  4/23 (17.39%)  1/22 (4.55%)  3/28 (10.71%)  3/16 (18.75%) 
Chest pain † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  2/28 (7.14%)  0/16 (0.00%) 
Asthenia † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Infections and infestations             
Osteomyelitis † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  1/22 (4.55%)  1/28 (3.57%)  0/16 (0.00%) 
Appendicitis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Bronchitis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Cellulitis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Gastroenteritis Viral † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Sepsis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Staphylococcal Infection † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Urinary Tract Infection Bacterial † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Urosepsis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications             
Arthritis Bacterial † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Hip Fracture † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Ankle Fracture † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Humerus Fracture † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Intentional Overdose † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders             
Hypoglycaemia † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Fluid Overload † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Hyperkalaemia † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Fasciitis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Gout † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Gouty Arthritis † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Lumbar Spinal Stenosis † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Muscular Weakness † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Musculoskeletal Pain † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Myositis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Pain in Extremity † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Rheumatoid Arthritis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Rotator Cuff Syndrome † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Myeloproliferative Disorder † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Nervous system disorders             
Carotid Artery Stenosis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Hepatic Encephalopathy † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Lumbar Radiculopathy † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Syncope † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Psychiatric disorders             
Depression † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Stress † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Suicide Attempt † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/16 (0.00%) 
Renal and urinary disorders             
Renal Failure Acute † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  1/22 (4.55%)  1/28 (3.57%)  1/16 (6.25%) 
Renal Failure † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Renal Failure Chronic † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Azotemia † 1  0/35 (0.00%)  0/25 (0.00%)  1/23 (4.35%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Nephrolithiasis † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Reproductive system and breast disorders             
Breast pain † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary Embolism † 1  2/35 (5.71%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Chronic Obstructive Pulmonary Disease † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Nasal Septum Deviation † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders             
Skin Necrosis † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Surgical and medical procedures             
Inguinal Hernia Repair † 1  1/35 (2.86%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Vascular disorders             
Deep Vein Thrombosis † 1  0/35 (0.00%)  0/25 (0.00%)  2/23 (8.70%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Femoral Artery Occlusion † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Hypertension † 1  0/35 (0.00%)  1/25 (4.00%)  0/23 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Hypotension † 1  0/35 (0.00%)  0/25 (0.00%)  0/23 (0.00%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
q2 RCT, Responder q4 RCT, Responder Placebo in RCT, q2 in OLE q2 RCT, Non-responder q4 RCT Non-responder Placebo in RCT, q4 in OLE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/35 (97.14%)   25/25 (100.00%)   23/23 (100.00%)   21/22 (95.45%)   28/28 (100.00%)   15/16 (93.75%) 
Eye disorders             
Cataract † 1  2/35 (5.71%)  3/25 (12.00%)  1/23 (4.35%)  0/22 (0.00%)  2/28 (7.14%)  0/16 (0.00%) 
Gastrointestinal disorders             
Diarrhoea † 1  7/35 (20.00%)  6/25 (24.00%)  3/23 (13.04%)  2/22 (9.09%)  4/28 (14.29%)  0/16 (0.00%) 
Nausea † 1  3/35 (8.57%)  5/25 (20.00%)  2/23 (8.70%)  2/22 (9.09%)  5/28 (17.86%)  0/16 (0.00%) 
Vomiting † 1  3/35 (8.57%)  3/25 (12.00%)  1/23 (4.35%)  2/22 (9.09%)  3/28 (10.71%)  0/16 (0.00%) 
Constipation † 1  3/35 (8.57%)  1/25 (4.00%)  3/23 (13.04%)  1/22 (4.55%)  2/28 (7.14%)  1/16 (6.25%) 
Abdominal Pain † 1  2/35 (5.71%)  2/25 (8.00%)  2/23 (8.70%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
General disorders             
Infusion Related Reaction † 1  7/35 (20.00%)  6/25 (24.00%)  13/23 (56.52%)  8/22 (36.36%)  19/28 (67.86%)  12/16 (75.00%) 
Oedema Peripheral † 1  7/35 (20.00%)  6/25 (24.00%)  5/23 (21.74%)  1/22 (4.55%)  2/28 (7.14%)  0/16 (0.00%) 
Fatigue † 1  7/35 (20.00%)  3/25 (12.00%)  5/23 (21.74%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Chest Pain † 1  1/35 (2.86%)  1/25 (4.00%)  2/23 (8.70%)  2/22 (9.09%)  4/28 (14.29%)  0/16 (0.00%) 
Infections and infestations             
Upper Respiratory Tract Invection † 1  8/35 (22.86%)  8/25 (32.00%)  4/23 (17.39%)  3/22 (13.64%)  4/28 (14.29%)  0/16 (0.00%) 
Urinary Tract Infection † 1  7/35 (20.00%)  5/25 (20.00%)  2/23 (8.70%)  2/22 (9.09%)  4/28 (14.29%)  0/16 (0.00%) 
Nasopharyngitis † 1  3/35 (8.57%)  5/25 (20.00%)  1/23 (4.35%)  1/22 (4.55%)  4/28 (14.29%)  1/16 (6.25%) 
Sinusitits † 1  4/35 (11.43%)  2/25 (8.00%)  1/23 (4.35%)  5/22 (22.73%)  3/28 (10.71%)  0/16 (0.00%) 
Cellulitis † 1  2/35 (5.71%)  1/25 (4.00%)  2/23 (8.70%)  3/22 (13.64%)  3/28 (10.71%)  1/16 (6.25%) 
Bronchitis † 1  6/35 (17.14%)  0/25 (0.00%)  2/23 (8.70%)  0/22 (0.00%)  2/28 (7.14%)  1/16 (6.25%) 
Gastroenteritis Viral † 1  1/35 (2.86%)  2/25 (8.00%)  3/23 (13.04%)  3/22 (13.64%)  1/28 (3.57%)  0/16 (0.00%) 
Influenza † 1  0/35 (0.00%)  3/25 (12.00%)  1/23 (4.35%)  3/22 (13.64%)  2/28 (7.14%)  1/16 (6.25%) 
Localised Infection † 1  2/35 (5.71%)  1/25 (4.00%)  3/23 (13.04%)  0/22 (0.00%)  1/28 (3.57%)  0/16 (0.00%) 
Injury, poisoning and procedural complications             
Fall † 1  3/35 (8.57%)  3/25 (12.00%)  2/23 (8.70%)  0/22 (0.00%)  0/28 (0.00%)  0/16 (0.00%) 
Skin Laceration † 1  2/35 (5.71%)  0/25 (0.00%)  1/23 (4.35%)  2/22 (9.09%)  3/28 (10.71%)  0/16 (0.00%) 
Metabolism and nutrition disorders             
Diabetes Mellitus † 1  2/35 (5.71%)  0/25 (0.00%)  2/23 (8.70%)  1/22 (4.55%)  0/28 (0.00%)  2/16 (12.50%) 
Musculoskeletal and connective tissue disorders             
Gout † 1 [1]  15/35 (42.86%)  19/25 (76.00%)  19/23 (82.61%)  16/22 (72.73%)  24/28 (85.71%)  13/16 (81.25%) 
Arthralgia † 1  7/35 (20.00%)  7/25 (28.00%)  6/23 (26.09%)  1/22 (4.55%)  8/28 (28.57%)  0/16 (0.00%) 
Pain in Extremity † 1  5/35 (14.29%)  8/25 (32.00%)  4/23 (17.39%)  1/22 (4.55%)  6/28 (21.43%)  2/16 (12.50%) 
Back Pain † 1  5/35 (14.29%)  4/25 (16.00%)  9/23 (39.13%)  3/22 (13.64%)  3/28 (10.71%)  1/16 (6.25%) 
Bursitis † 1  3/35 (8.57%)  2/25 (8.00%)  1/23 (4.35%)  0/22 (0.00%)  3/28 (10.71%)  0/16 (0.00%) 
Osteoarthritis † 1  2/35 (5.71%)  4/25 (16.00%)  1/23 (4.35%)  0/22 (0.00%)  2/28 (7.14%)  0/16 (0.00%) 
Musculoskeletal pain † 1  2/35 (5.71%)  2/25 (8.00%)  1/23 (4.35%)  1/22 (4.55%)  1/28 (3.57%)  0/16 (0.00%) 
Shoulder Pain † 1  2/35 (5.71%)  2/25 (8.00%)  1/23 (4.35%)  1/22 (4.55%)  1/28 (3.57%)  0/16 (0.00%) 
Tendonitis † 1  2/35 (5.71%)  0/25 (0.00%)  1/23 (4.35%)  2/22 (9.09%)  2/28 (7.14%)  0/16 (0.00%) 
Nervous system disorders             
Headache † 1  4/35 (11.43%)  5/25 (20.00%)  4/23 (17.39%)  2/22 (9.09%)  0/28 (0.00%)  1/16 (6.25%) 
Dizziness † 1  1/35 (2.86%)  3/25 (12.00%)  0/23 (0.00%)  2/22 (9.09%)  1/28 (3.57%)  0/16 (0.00%) 
Psychiatric disorders             
Depression † 1  1/35 (2.86%)  1/25 (4.00%)  1/23 (4.35%)  1/22 (4.55%)  2/28 (7.14%)  2/16 (12.50%) 
Renal and urinary disorders             
Haematuria † 1  2/35 (5.71%)  1/25 (4.00%)  1/23 (4.35%)  1/22 (4.55%)  2/28 (7.14%)  0/16 (0.00%) 
Nephrolithiasis † 1  0/35 (0.00%)  1/25 (4.00%)  1/23 (4.35%)  1/22 (4.55%)  3/28 (10.71%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders             
Cough † 1  8/35 (22.86%)  2/25 (8.00%)  3/23 (13.04%)  0/22 (0.00%)  0/28 (0.00%)  1/16 (6.25%) 
Dyspnoea † 1  1/35 (2.86%)  2/25 (8.00%)  1/23 (4.35%)  1/22 (4.55%)  1/28 (3.57%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders             
Rash † 1  2/35 (5.71%)  4/25 (16.00%)  2/23 (8.70%)  1/22 (4.55%)  1/28 (3.57%)  1/16 (6.25%) 
Pruritus † 1  1/35 (2.86%)  3/25 (12.00%)  2/23 (8.70%)  1/22 (4.55%)  1/28 (3.57%)  0/16 (0.00%) 
Vascular disorders             
Hypertension † 1  3/35 (8.57%)  2/25 (8.00%)  3/23 (13.04%)  3/22 (13.64%)  1/28 (3.57%)  0/16 (0.00%) 
Flushing † 1  1/35 (2.86%)  3/25 (12.00%)  1/23 (4.35%)  2/22 (9.09%)  1/28 (3.57%)  0/16 (0.00%) 
Hypotension † 1  1/35 (2.86%)  2/25 (8.00%)  1/23 (4.35%)  0/22 (0.00%)  3/28 (10.71%)  0/16 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
[1]
Preferred Term 'Gout' includes the preferred term for lower level term 'gout flare'
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Savient Pharmaceuticals, Inc.
Phone: 732-418-9300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Savient Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01356498    
Other Study ID Numbers: C0407
First Submitted: October 27, 2008
First Posted: May 19, 2011
Results First Submitted: August 5, 2011
Results First Posted: December 2, 2011
Last Update Posted: December 2, 2011