Gout
Conditions
Keywords
gout, chronic gout
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.
Interventions
BIOLOGICALpegloticase
8 mg intravenous infusion
Sponsors
Savient Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uric Acid (mg/dL) | Week 13, Week 25, Week 53, Week 101 | Uric acid measured at 3 month-intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tophus Response | Up to 2 years | Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus. |
| Patient Reported Outcome: SF-36 Physical Component Summary Score | RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101 | SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status. |
| Gout Flare Frequency | Up to 2 years | The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment |
| Gout Flare Incidence | Assessed in 3-month intervals up to 2 years | Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 25 |
| 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 | 23 |
| 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 | 22 |
| 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 | 28 |
| 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 | 16 |
| Total | 149 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 8 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 18 Participants | 16 Participants | 23 Participants | 11 Participants | 105 Participants |
| Age Continuous | 62.4 years STANDARD_DEVIATION 13.66 | 58.6 years STANDARD_DEVIATION 13.59 | 56.6 years STANDARD_DEVIATION 10.53 | 52.0 years STANDARD_DEVIATION 13.12 | 53.5 years STANDARD_DEVIATION 12.25 | 54.6 years STANDARD_DEVIATION 13.62 | 56.8 years STANDARD_DEVIATION 13.19 |
| Region of Enrollment Canada | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Region of Enrollment Mexico | 3 participants | 2 participants | 0 participants | 5 participants | 1 participants | 3 participants | 14 participants |
| Region of Enrollment United States | 32 participants | 22 participants | 22 participants | 17 participants | 27 participants | 13 participants | 133 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 32 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 19 Participants | 18 Participants | 24 Participants | 13 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 35 | 25 / 25 | 23 / 23 | 21 / 22 | 28 / 28 | 15 / 16 |
| serious Total, serious adverse events | 9 / 35 | 7 / 25 | 8 / 23 | 7 / 22 | 12 / 28 | 8 / 16 |
Outcome results
Primary
Uric Acid (mg/dL)
Uric acid measured at 3 month-intervals
Time frame: Week 13, Week 25, Week 53, Week 101
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| q2 RCT, Responder | Uric Acid (mg/dL) | OLE Week 25 | 1.4 mg/dL | Standard Deviation 3.196 |
| q2 RCT, Responder | Uric Acid (mg/dL) | OLE Week 101 | 0.84 mg/dL | Standard Deviation 2.619 |
| q2 RCT, Responder | Uric Acid (mg/dL) | OLE Week 53 | 0.87 mg/dL | Standard Deviation 2.327 |
| q2 RCT, Responder | Uric Acid (mg/dL) | OLE Week 13 | 1.33 mg/dL | Standard Deviation 3.103 |
| q4 RCT, Responder | Uric Acid (mg/dL) | OLE Week 13 | 1.91 mg/dL | Standard Deviation 4.082 |
| q4 RCT, Responder | Uric Acid (mg/dL) | OLE Week 25 | 1.95 mg/dL | Standard Deviation 3.761 |
| q4 RCT, Responder | Uric Acid (mg/dL) | OLE Week 53 | 1.55 mg/dL | Standard Deviation 3.69 |
| q4 RCT, Responder | Uric Acid (mg/dL) | OLE Week 101 | 1.47 mg/dL | Standard Deviation 3.317 |
| Placebo in RCT, q2 in OLE | Uric Acid (mg/dL) | OLE Week 25 | 4.69 mg/dL | Standard Deviation 4.454 |
| Placebo in RCT, q2 in OLE | Uric Acid (mg/dL) | OLE Week 53 | 2.7 mg/dL | Standard Deviation 4.255 |
| Placebo in RCT, q2 in OLE | Uric Acid (mg/dL) | OLE Week 101 | 4.29 mg/dL | Standard Deviation 3.985 |
| Placebo in RCT, q2 in OLE | Uric Acid (mg/dL) | OLE Week 13 | 5.06 mg/dL | Standard Deviation 4.538 |
| q2 RCT, Non-responder | Uric Acid (mg/dL) | OLE Week 25 | 8.89 mg/dL | Standard Deviation 3.984 |
| q2 RCT, Non-responder | Uric Acid (mg/dL) | OLE Week 13 | 9.76 mg/dL | Standard Deviation 1.346 |
| q2 RCT, Non-responder | Uric Acid (mg/dL) | OLE Week 53 | 9.18 mg/dL | Standard Deviation 2.946 |
| q2 RCT, Non-responder | Uric Acid (mg/dL) | OLE Week 101 | 7.7 mg/dL | Standard Deviation 4.244 |
| q4 RCT Non-responder | Uric Acid (mg/dL) | OLE Week 53 | 9.59 mg/dL | Standard Deviation 2.782 |
| q4 RCT Non-responder | Uric Acid (mg/dL) | OLE Week 13 | 9.66 mg/dL | Standard Deviation 2.529 |
| q4 RCT Non-responder | Uric Acid (mg/dL) | OLE Week 101 | 9.42 mg/dL | Standard Deviation 1.961 |
| q4 RCT Non-responder | Uric Acid (mg/dL) | OLE Week 25 | 9.94 mg/dL | Standard Deviation 2.646 |
| Placebo in RCT, q4 in OLE | Uric Acid (mg/dL) | OLE Week 25 | 8.09 mg/dL | Standard Deviation 3.536 |
| Placebo in RCT, q4 in OLE | Uric Acid (mg/dL) | OLE Week 53 | 6.45 mg/dL | Standard Deviation 3.248 |
| Placebo in RCT, q4 in OLE | Uric Acid (mg/dL) | OLE Week 13 | 8.08 mg/dL | Standard Deviation 3.561 |
| Placebo in RCT, q4 in OLE | Uric Acid (mg/dL) | OLE Week 101 | 8.5 mg/dL | — |
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
Time frame: Up to 2 years
Population: Analysis is based on ITT population, and is presented by intervals of time on pegloticase
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| q2 RCT, Responder | Gout Flare Frequency | Months 10-12 | 0.1 Flares | Standard Deviation 0.3 |
| q2 RCT, Responder | Gout Flare Frequency | Months 4-6 | 0.4 Flares | Standard Deviation 0.96 |
| q2 RCT, Responder | Gout Flare Frequency | Months 7-9 | 0.0 Flares | Standard Deviation 0.17 |
| q2 RCT, Responder | Gout Flare Frequency | Months 16-18 | 0.1 Flares | Standard Deviation 0.25 |
| q2 RCT, Responder | Gout Flare Frequency | Months 1-3 | 0.4 Flares | Standard Deviation 0.69 |
| q2 RCT, Responder | Gout Flare Frequency | Months 22-24 | 0.1 Flares | Standard Deviation 0.37 |
| q4 RCT, Responder | Gout Flare Frequency | Months 22-24 | 0.1 Flares | Standard Deviation 0.23 |
| q4 RCT, Responder | Gout Flare Frequency | Months 10-12 | 0.2 Flares | Standard Deviation 0.51 |
| q4 RCT, Responder | Gout Flare Frequency | Months 4-6 | 0.7 Flares | Standard Deviation 0.95 |
| q4 RCT, Responder | Gout Flare Frequency | Months 16-18 | .3 Flares | Standard Deviation 0.44 |
| q4 RCT, Responder | Gout Flare Frequency | Months 1-3 | 0.8 Flares | Standard Deviation 0.9 |
| q4 RCT, Responder | Gout Flare Frequency | Months 7-9 | 0.3 Flares | Standard Deviation 0.54 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 10-12 | 0.6 Flares | Standard Deviation 1.18 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 22-24 | 0.4 Flares | Standard Deviation 0.67 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 1-3 | 2.3 Flares | Standard Deviation 2.91 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 7-9 | 1.2 Flares | Standard Deviation 1.8 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 4-6 | 1.3 Flares | Standard Deviation 2.17 |
| Placebo in RCT, q2 in OLE | Gout Flare Frequency | Months 16-18 | 0.2 Flares | Standard Deviation 0.4 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 7-9 | 0.6 Flares | Standard Deviation 1.2 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 4-6 | 1.0 Flares | Standard Deviation 1.73 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 1-3 | 0.6 Flares | Standard Deviation 0.9 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 10-12 | 0.9 Flares | Standard Deviation 1.34 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 22-24 | 0.3 Flares | Standard Deviation 0.65 |
| q2 RCT, Non-responder | Gout Flare Frequency | Months 16-18 | 0.7 Flares | Standard Deviation 1.18 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 4-6 | 0.8 Flares | Standard Deviation 0.94 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 22-24 | 0.6 Flares | Standard Deviation 0.53 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 7-9 | 0.6 Flares | Standard Deviation 0.97 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 1-3 | 1.3 Flares | Standard Deviation 1.49 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 10-12 | 0.9 Flares | Standard Deviation 1.46 |
| q4 RCT Non-responder | Gout Flare Frequency | Months 16-18 | 0.6 Flares | Standard Deviation 0.85 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 22-24 | 0.7 Flares | Standard Deviation 1.15 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 1-3 | 1.5 Flares | Standard Deviation 1.41 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 4-6 | 0.8 Flares | Standard Deviation 1.18 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 7-9 | 0.4 Flares | Standard Deviation 1.01 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 10-12 | 0.4 Flares | Standard Deviation 0.63 |
| Placebo in RCT, q4 in OLE | Gout Flare Frequency | Months 16-18 | 0.4 Flares | Standard Deviation 0.89 |
Secondary
Gout Flare Incidence
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
Population: The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| q2 RCT, Responder | Gout Flare Incidence | Months 1-3 | 25.7 Percentage of participants |
| q2 RCT, Responder | Gout Flare Incidence | Months 4-6 | 23.5 Percentage of participants |
| q2 RCT, Responder | Gout Flare Incidence | Months 7-9 | 3.0 Percentage of participants |
| q2 RCT, Responder | Gout Flare Incidence | Months 10-12 | 9.4 Percentage of participants |
| q2 RCT, Responder | Gout Flare Incidence | Months 16-18 | 6.5 Percentage of participants |
| q2 RCT, Responder | Gout Flare Incidence | Months 22-24 | 3.4 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 4-6 | 40.0 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 10-12 | 16.7 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 22-24 | 5.3 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 1-3 | 56.0 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 7-9 | 24.0 Percentage of participants |
| q4 RCT, Responder | Gout Flare Incidence | Months 16-18 | 25.0 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 22-24 | 27.3 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 16-18 | 18.2 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 10-12 | 28.6 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 7-9 | 43.8 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 1-3 | 65.2 Percentage of participants |
| Placebo in RCT, q2 in OLE | Gout Flare Incidence | Months 4-6 | 45.0 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 10-12 | 47.1 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 4-6 | 35.0 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 7-9 | 27.8 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 22-24 | 25.0 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 16-18 | 33.3 Percentage of participants |
| q2 RCT, Non-responder | Gout Flare Incidence | Months 1-3 | 45.5 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 1-3 | 67.9 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 16-18 | 38.9 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 4-6 | 50.0 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 7-9 | 42.9 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 10-12 | 45.0 Percentage of participants |
| q4 RCT Non-responder | Gout Flare Incidence | Months 22-24 | 55.6 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 10-12 | 28.6 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 7-9 | 22.2 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 16-18 | 20.0 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 22-24 | 33.3 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 4-6 | 38.5 Percentage of participants |
| Placebo in RCT, q4 in OLE | Gout Flare Incidence | Months 1-3 | 68.8 Percentage of participants |
Secondary
Patient Reported Outcome: SF-36 Physical Component Summary Score
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.
Time frame: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
Population: Number of participants was the subset of the ITT population with SF-36 baseline data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| q2 RCT, Responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 34.92 units on a scale | Standard Deviation 10.988 |
| q2 RCT, Responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 40.40 units on a scale | Standard Deviation 13.393 |
| q4 RCT, Responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 34.11 units on a scale | Standard Deviation 10.022 |
| q4 RCT, Responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 40.82 units on a scale | Standard Deviation 7.482 |
| Placebo in RCT, q2 in OLE | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 27.55 units on a scale | Standard Deviation 11.405 |
| Placebo in RCT, q2 in OLE | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 30.34 units on a scale | Standard Deviation 11.132 |
| q2 RCT, Non-responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 33.71 units on a scale | Standard Deviation 11.581 |
| q2 RCT, Non-responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 37.68 units on a scale | Standard Deviation 10.298 |
| q4 RCT Non-responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 32.8 units on a scale | Standard Deviation 10.129 |
| q4 RCT Non-responder | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 34.76 units on a scale | Standard Deviation 11.413 |
| Placebo in RCT, q4 in OLE | Patient Reported Outcome: SF-36 Physical Component Summary Score | Baseline value (pre-pegloticase) | 36.2 units on a scale | Standard Deviation 11.926 |
| Placebo in RCT, q4 in OLE | Patient Reported Outcome: SF-36 Physical Component Summary Score | Final Visit value (LOCF) | 38.8 units on a scale | Standard Deviation 13.155 |
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.
Time frame: Up to 2 years
Population: ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| q2 RCT, Responder | Tophus Response | Complete Response | 19 participants |
| q2 RCT, Responder | Tophus Response | Partial Response | 4 participants |
| q4 RCT, Responder | Tophus Response | Complete Response | 13 participants |
| q4 RCT, Responder | Tophus Response | Partial Response | 0 participants |
| Placebo in RCT, q2 in OLE | Tophus Response | Complete Response | 10 participants |
| Placebo in RCT, q2 in OLE | Tophus Response | Partial Response | 3 participants |
| q2 RCT, Non-responder | Tophus Response | Complete Response | 4 participants |
| q2 RCT, Non-responder | Tophus Response | Partial Response | 4 participants |
| q4 RCT Non-responder | Tophus Response | Complete Response | 7 participants |
| q4 RCT Non-responder | Tophus Response | Partial Response | 2 participants |
| Placebo in RCT, q4 in OLE | Tophus Response | Complete Response | 3 participants |
| Placebo in RCT, q4 in OLE | Tophus Response | Partial Response | 1 participants |