NCT05925166

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout

Safety and Efficacy of Of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein In Acute Gout

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Lihua Duan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the efficacy and safety of Recombinant Human Tumor necrosis Factor-α Receptor Ⅱ Fusion Protein （rhTNFR-Fc）in the treatment of patients with acute Gout.

Detailed description

Gout is a disease in which uric acid level exceeds its saturation in blood or tissue fluid due to purine metabolism disorder, excessive production or reduced excretion of uric acid, and thus sodium urate crystals are formed and deposited locally in joints, inducing local inflammatory response and tissue destruction. According to the guidelines for the diagnosis and treatment of gout, it is recommended to use small doses of colchicine or NSAID or glucocorticoid as early as possible (sufficient amount and short course) for treatment in the acute stage of gouty arthritis. Gout patients with intolerance, poor efficacy or contraindications of the above-mentioned drugs are usually considered as refractory gout, which is difficult to treat and lacks universally effective drugs. Recombinant human tumor necrosis factor-α receptor Ⅱ fusion protein（rhTNFR-Fc） has effective anti-inflammatory effect in rheumatoid arthritis, ankylosing spondylitis and other rheumatic diseases. This is a multicenter, prospective, open-label, two-arm study.Subjects will be administered etanercept at a dose of 25mg twice in 5 days(day 1 and the day 3) subcutaneously (SC) at the onset of an acute gout attack, or the methylprednisolone group received 20mgmethylprednisolone administered intravenously every day for a total of five days to evaluate the efficacy and safety of rhTNFR-Fc in the treatment of patients with acute Gout.

Conditions

• Acute Gout

Interventions

Type	Name	Description
DRUG	rhTNFR-Fc	Subjects will receive a dose of 25mg twice in 5 days(day 1 and the day 3).
DRUG	methylprednisolone	Subjects will be administered methylprednisolone 20 mg intravenous.

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-07-01
• Completion: 2026-01-31
• First posted: 2023-06-29
• Last updated: 2026-04-15

Locations

1 site across 1 country: China