- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174941
Long-Term Safety of Febuxostat in Subjects With Gout. (FOCUS)
Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
|
Experimental: 2
|
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
|
Experimental: 3
|
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 6
|
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.
|
Month 12
|
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.
|
Month 18
|
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.
|
Month 24
|
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.
|
Month 36
|
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.
|
Month 48
|
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.
|
Month 60
|
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.
|
Last Visit on treatment (up to 66 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Month 6
|
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.
|
Baseline and Month 12
|
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.
|
Baseline and Month 18
|
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.
|
Baseline and Month 24
|
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.
|
Baseline and Month 36
|
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.
|
Baseline and Month 48
|
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.
|
Baseline and Month 60
|
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.
|
Baseline and Last Visit on treatment (up to 66 months).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.
- Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457.
- Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMX-01-005
- U1111-1114-2039 (Registry Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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