Joint Damage Clinical Trial
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
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.
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 patients with gout.
Current treatments focus on initiating urate-lowering therapy in hyperuricemic gout patients
who have experienced multiple 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 in patients with gout.
This study will evaluate the effect of febuxostat on joint damage in hyperuricemic patients
with early gout. All patients 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/Van Der Heijde scoring method (named after Drs. Sharp and
Van Der Heijde) for assessment of x-rays has been validated in patients with chronic gout
and will be used in this study for evaluating erosion and 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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment