Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

Summary

This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.

Timeline

Start

2012-01

Primary completion

2014-06

Completion

2014-06

Outcome

Mixed primary results

registry analysis (superiority or other test); Lesinurad 200 mg + Febuxostat 80 mg vs Placebo + Febuxostat 80 mg; p = 0.1298 NCT01510769 ↗

registry analysis (superiority or other test); Lesinurad 400 mg + Febuxostat 80 mg vs Placebo + Febuxostat 80 mg; p <0.0001 NCT01510769 ↗

Publications

• Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
• Dalbeth N, Jones G, Terkeltaub R, Khanna D, Fung M, Baumgartner S, Perez-Ruiz F. Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study. Arthritis Res Ther. 2019 Jan 7;21(1):8. doi: 10.1186/s13075-018-1788-4.
• Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, Adler S, Fung M, Storgard C, Baumgartner S, Perez-Ruiz F. Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lesinurad	Small molecule	200 mg	—
Subject	Lesinurad	Small molecule	400 mg	—
Background	Febuxostat	Small molecule	80 mg	—

Indications