Long-Term Safety of Febuxostat in Subjects With Gout. (FOCUS)
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| ClinicalTrials.gov Identifier: NCT00174941 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : January 27, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gout | Drug: Febuxostat | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout |
| Study Start Date : | March 2001 |
| Actual Primary Completion Date : | December 2006 |
| Actual Study Completion Date : | December 2006 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Febuxostat
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
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| Experimental: 2 |
Drug: Febuxostat
Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
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| Experimental: 3 |
Drug: Febuxostat
Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
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- Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
- Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. [ Time Frame: 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.
- Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174941
| Study Chair: | Medical Director | Takeda |
Publications of Results:
| Responsible Party: | Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00174941 |
| Other Study ID Numbers: |
TMX-01-005 U1111-1114-2039 ( Registry Identifier: WHO ) |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | July 16, 2009 |
| Last Update Posted: | January 27, 2011 |
| Last Verified: | January 2011 |
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Uric acid xanthine oxidase tophi Drug Therapy |
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Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Febuxostat Gout Suppressants Antirheumatic Agents |