Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in subjects with elevated serum urate levels and gout.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxostat Versus Placebo in Joint Damage in Hyperuricemic Subjects With Early Gout|
- Mean Change from Baseline to Month 24 in a modified Sharp/van der Heijde Erosion Score of the single affected joint. [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
- Mean Change from Baseline to Month 24 in the modified Sharp/van der Heijde Total Scores from full hand and foot radiographs. [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
- Mean Change from Baseline to Month 24 in the modified Sharp/van der Heijde Erosion Scores from full hand and foot radiographs. [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
- Mean change from baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) score. [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
- Mean change from baseline to Month 24 in a modified Sharp/van der Heijde Total Score of the single affected joint. [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Febuxostat 40 mg or 80 mg QD
(based on serum urate levels)
Febuxostat 40 mg or 80 mg (based on serum urate levels), capsules, orally, once daily for up to 24 Months.
|Placebo Comparator: Placebo QD||
Placebo-matching capsules, orally, once daily for up to 24 Months.
Gout is caused by high levels of uric acid in the body, and is associated with a broad range of comorbidities including heart disease, chronic kidney disease and additional risk factors like obesity and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form from supersaturated body fluids and settle in joints and other organs. Urate-lowering therapy is used to treat hyperuricemia in subjects with gout.
Current treatments focus on initiating urate-lowering therapy in hyperuricemic gout patients who have experienced 3 or more acute gout flares within the past year. However, joint damage caused by crystal deposition may occur much earlier than previously considered. Monosodium urate crystals have been found present in the joints of people with hyperuricemia who do not have any symptoms. The presence of monosodium urate crystals would indicate that after the crystals form, they stay within the joint if serum urate levels are not reduced. Lowering uric acid levels and maintaining them may reduce acute gout flare episodes and possibly halt or reduce joint damage
This study will evaluate the effect of febuxostat on joint damage in hyperuricemic subjects with early gout. All subjects will receive gout flare prophylaxis for the first 6 months of the study. Gout flares may also be treated throughout the study.
A variety of imaging techniques are in use to evaluate gout. Plain radiographs (x-rays), Magnetic Resonance Imaging (MRI) and Dual Energy Computed Tomography (DECT) will be utilized in this study. The modified SHARP Erosion scoring method (named after Dr. Sharp) has been validated in subjects with chronic gout and will be used in this study for evaluating joint space narrowing. Participants are expected to have 15 visits which will include plain radiographic examinations at 5 visits, 3 Magnetic Resonance Imaging (MRI) examinations and 3 DECT procedures at selected sites.
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|Study Director:||Medical Director||Takeda|