Gout
Conditions
Keywords
Uric acid, xanthine oxidase, tophi, Drug Therapy
Brief summary
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
Detailed description
Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter \[mg/dL\]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout. Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967). All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
Interventions
DRUGFebuxostat
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004). * Must meet American College of Rheumatology criteria for gout. * Must have adequate renal function (serum creatinine \<1.5 mg/dL). * Must have completed four weeks of double-blind dosing in Study TMX-00-004. * Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004. * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion criteria
* History of xanthinuria * Alcohol consumption \>14/week * Has a History of significant concomitant illness * Has active liver disease. * Has a body mass index greater than 50 kg/m2 * Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | Last Visit on treatment (up to 66 months). | The percentage of subjects whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Month 6 | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | Month 12 | Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | Month 18 | Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | Month 24 | Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | Month 36 | Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | Month 48 | Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized. |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | Month 60 | Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Baseline and Month 6 | Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | Baseline and Month 12 | Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | Baseline and Month 18 | Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | Baseline and Month 24 | Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | Baseline and Month 36 | Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | Baseline and Month 48 | Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized. |
| Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | Baseline and Month 60 | The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation. |
| Percent Change in Serum Urate Levels From Baseline at Final Visit. | Baseline and Last Visit on treatment (up to 66 months). | The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. |
Participant flow
Recruitment details
Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006
Pre-assignment details
Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
Participants by arm
| Arm | Count |
|---|---|
| Febuxostat 40 mg QD Febuxostat 40 mg orally, once daily, based on serum urate level. | 8 |
| Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily, based on serum urate level | 79 |
| Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily, based on serum urate level | 29 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 10 | 2 | 13 |
| Overall Study | Gout Flare | 0 | 4 | 4 | 8 |
| Overall Study | Lost to Follow-up | 0 | 3 | 2 | 5 |
| Overall Study | Personal Reason(s) | 0 | 14 | 8 | 22 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
| Overall Study | Reason Not Specified | 1 | 6 | 2 | 9 |
Baseline characteristics
| Characteristic | Febuxostat 40 mg QD | Febuxostat 80 mg QD | Febuxostat 120 mg QD | Total |
|---|---|---|---|---|
| Age Continuous | 54.5 years STANDARD_DEVIATION 11.44 | 53.9 years STANDARD_DEVIATION 12.85 | 51.3 years STANDARD_DEVIATION 13.01 | 53.3 years STANDARD_DEVIATION 12.74 |
| Age, Customized 45 to <65 years | 4 Subjects | 40 Subjects | 15 Subjects | 59 Subjects |
| Age, Customized <45 years | 2 Subjects | 20 Subjects | 9 Subjects | 31 Subjects |
| Age, Customized ≥65 years | 2 Subjects | 19 Subjects | 5 Subjects | 26 Subjects |
| Body Mass Index | 28.4 kiligram per meter² (kg/m²) STANDARD_DEVIATION 2.78 | 32.9 kiligram per meter² (kg/m²) STANDARD_DEVIATION 5.28 | 33.9 kiligram per meter² (kg/m²) STANDARD_DEVIATION 6.82 | 32.9 kiligram per meter² (kg/m²) STANDARD_DEVIATION 5.69 |
| History of Kidney Stone No | 8 Subjects | 68 Subjects | 26 Subjects | 102 Subjects |
| History of Kidney Stone Yes | 0 Subjects | 11 Subjects | 3 Subjects | 14 Subjects |
| Presence of Tophus No | 7 Subjects | 66 Subjects | 17 Subjects | 90 Subjects |
| Presence of Tophus Yes | 1 Subjects | 13 Subjects | 12 Subjects | 26 Subjects |
| Race/Ethnicity Asian | 0 Subjects | 0 Subjects | 2 Subjects | 2 Subjects |
| Race/Ethnicity Black or African American | 1 Subjects | 5 Subjects | 3 Subjects | 9 Subjects |
| Race/Ethnicity Hispanic | 0 Subjects | 2 Subjects | 1 Subjects | 3 Subjects |
| Race/Ethnicity Other | 0 Subjects | 1 Subjects | 2 Subjects | 3 Subjects |
| Race/Ethnicity White | 7 Subjects | 71 Subjects | 21 Subjects | 99 Subjects |
| Renal Function Impaired | 5 Subjects | 46 Subjects | 17 Subjects | 68 Subjects |
| Renal Function Normal | 3 Subjects | 33 Subjects | 12 Subjects | 48 Subjects |
| Serum Urate | 9.58 mg/dL STANDARD_DEVIATION 1.18 | 9.48 mg/dL STANDARD_DEVIATION 1.04 | 10.23 mg/dL STANDARD_DEVIATION 1.74 | 9.7 mg/dL STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 0 Participants | 9 Participants | 2 Participants | 11.0 Participants |
| Sex: Female, Male Male | 8 Participants | 70 Participants | 27 Participants | 105.0 Participants |
| Urine Uric Acid Missing | 0 Subjects | 1 Subjects | 1 Subjects | 2 Subjects |
| Urine Uric Acid Overproducer | 3 Subjects | 16 Subjects | 7 Subjects | 26 Subjects |
| Urine Uric Acid Underexcretor | 5 Subjects | 62 Subjects | 21 Subjects | 88 Subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 12 | 44 / 116 | 9 / 37 | 53 / 116 |
| serious Total, serious adverse events | 3 / 12 | 14 / 116 | 4 / 37 | 21 / 116 |
Outcome results
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
The percentage of subjects whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time frame: Last Visit on treatment (up to 66 months).
Population: Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | 100 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | 82 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | 81 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. | 83 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized.
Time frame: Month 12
Population: Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 57 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 85 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 67 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 79 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized.
Time frame: Month 18
Population: Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | 50 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | 82 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | 57 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | 74 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized.
Time frame: Month 24
Population: Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 63 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 76 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 92 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 77 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized.
Time frame: Month 36
Population: Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | 67 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | 84 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | 92 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | 84 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized.
Time frame: Month 48
Population: Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | 83 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | 92 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | 85 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | 90 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized.
Time frame: Month 60
Population: Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | 100 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | 93 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | 91 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | 93 percentage of subjects |
Primary
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized.
Time frame: Month 6
Population: Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Febuxostat 40 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | 50 percentage of subjects |
| Febuxostat 80 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | 93 percentage of subjects |
| Febuxostat 120 mg QD | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | 65 percentage of subjects |
| Total Febuxostat | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | 82 percentage of subjects |
Secondary
Percent Change in Serum Urate Levels From Baseline at Final Visit.
The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time frame: Baseline and Last Visit on treatment (up to 66 months).
Population: Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Final Visit. | -49.2 percent change from baseline | Standard Deviation 7.1 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Final Visit. | -47.1 percent change from baseline | Standard Deviation 16.42 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Final Visit. | -50.7 percent change from baseline | Standard Deviation 19.12 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Final Visit. | -48.1 percent change from baseline | Standard Deviation 16.61 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.
Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.
Time frame: Baseline and Month 12
Population: Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | -35.0 percentage of subjects | Standard Deviation 13.16 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | -49.7 percentage of subjects | Standard Deviation 9.26 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | -49.3 percentage of subjects | Standard Deviation 15.77 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | -48.3 percentage of subjects | Standard Deviation 11.94 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.
Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.
Time frame: Baseline and Month 18
Population: Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | -35.5 percent change from baseline | Standard Deviation 16.35 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | -48.7 percent change from baseline | Standard Deviation 11.12 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | -39.5 percent change from baseline | Standard Deviation 19.36 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | -45.4 percent change from baseline | Standard Deviation 14.35 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.
Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.
Time frame: Baseline and Month 24
Population: Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | -38.9 percent change from baseline | Standard Deviation 19.41 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | -46.7 percent change from baseline | Standard Deviation 11.59 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | -54.7 percent change from baseline | Standard Deviation 12.02 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | -47.3 percent change from baseline | Standard Deviation 13.24 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.
Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.
Time frame: Baseline and Month 36
Population: Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | -43.0 percent change from baseline | Standard Deviation 9.14 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | -46.9 percent change from baseline | Standard Deviation 13.35 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | -56.4 percent change from baseline | Standard Deviation 13.76 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | -48.4 percent change from baseline | Standard Deviation 13.6 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.
Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.
Time frame: Baseline and Month 48
Population: Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | -50.0 percent change from baseline | Standard Deviation 4.16 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | -50.3 percent change from baseline | Standard Deviation 10.61 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | -53.8 percent change from baseline | Standard Deviation 16.41 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | -51.1 percent change from baseline | Standard Deviation 11.64 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.
The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.
Time frame: Baseline and Month 60
Population: Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | -45.5 percent change from baseline | Standard Deviation 8.7 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | -51.1 percent change from baseline | Standard Deviation 13.21 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | -59.0 percent change from baseline | Standard Deviation 18.74 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | -52.0 percent change from baseline | Standard Deviation 14.32 |
Secondary
Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Time frame: Baseline and Month 6
Population: Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Febuxostat 40 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | -35.9 percent change from baseline | Standard Deviation 9.55 |
| Febuxostat 80 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | -50.6 percent change from baseline | Standard Deviation 9.84 |
| Febuxostat 120 mg QD | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | -47.6 percent change from baseline | Standard Deviation 19.6 |
| Total Febuxostat | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | -48.3 percent change from baseline | Standard Deviation 13.07 |