CompletedNot Applicable

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

China26 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Can voluntarily sign the informed consent, and voluntarily cooperate with the completion of the experiment according to the plan;
✓. 18 years old ≤ 75 years old, male and female;
✓. Body mass index (BMI) ≤ 40 kg/m2;
✓. Patients diagnosed with gout according to the American College of Rheumatology (ACR) 2015 gout classification criteria;
✓. The current acute gout attack occurred within 4 days before the screening period;
✓. The pain degree of target joint during the screening period was VAS≥ 5 mm (VAS 0-10mm);
✓. We are willing to follow the protocol of uric acid lowering therapy (ULT) during the study period and meet the following conditions One:

Exclusion criteria

✕. There is a history of allergic reaction to the investigational drug or similar drugs;
✕. People who have received any of the following drugs or treatments:
✕. Use of NASIADs within 24 hours prior to enrollment;
✕. Used ≥ 5 mg prednisone or equivalent dose of glucocorticoid in the 24 hours prior to enrollment;
✕. used short-acting painkillers such as tramadol within 24 hours before enrollment;
✕. Use of long-acting opioid therapy within 14 days prior to screening;
✕. Intraarticular injection of glucocorticoids within 14 days prior to screening;
✕. Use of any IL-1 blocker, TNF inhibitor, or other biologics within 30 days prior to screening or within 3 half-lives, whichever is older;

What they're measuring

Joint pain intensity in the most affected joint

Timeframe: 5 day

Acute gout recurrence time

Timeframe: within 4 weeks

Trial details

NCT IDNCT05925166

SponsorLihua Duan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Acute Gout trials