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

NCT05925166 | Completed

• 1 other identifier: DLH86895639
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Gout

Keywords

rhTNFR-Fc、Acute Gout

Outcome Measures

Primary Outcomes (2)

• Joint pain intensity in the most affected joint

  Pain intensity in the most affected baseline joint measured by the numeric 0-10 pain scale at 72 hours

  5 day

• Acute gout recurrence time

  Time from baseline to first acute gout recurrence

  within 4 weeks

Secondary Outcomes (6)

• Joint pain on numeric pain scale

  Days 5

• Patient's assessment of response to treatment

  Day 5

• Physician's assessment of response to treatment

  Day 5

• Rescue Medication

  Day 5

• Safety and Tolerability of rhTNFR-Fc

  Day 5

Study Arms (2)

rhTNFR-Fc

EXPERIMENTAL

Subjects will be administered rhTNFR-Fc 50 mg subcutaneously

Drug: rhTNFR-Fc

methylprednisolone

ACTIVE COMPARATOR

Subjects will be administered methylprednisolone 20 mg intravenous

Drug: methylprednisolone

Interventions

methylprednisolone DRUG

Subjects will be administered methylprednisolone 20 mg intravenous.

methylprednisolone

rhTNFR-Fc DRUG

Subjects will receive a dose of 25mg twice in 5 days(day 1 and the day 3).

Also known as: etanercept、Yisaipu

rhTNFR-Fc

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can voluntarily sign the informed consent, and voluntarily cooperate with the completion of the experiment according to the plan;
• 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:
• (1) Patients who are receiving ULT and stable treatment for ≥14 days should maintain the stable medication regimen for at least 12 weeks during the trial period. Unless the patient with the original uric-lowering regimen is evaluated by the investigator as having intolerance, poor efficacy or low uric acid, adjustment of the uric-lowering regimen including drug change, dose reduction or drug discontinuation is allowed;
• ② Patients who did not use ULT before randomization were not allowed to take uric-lowering therapy within 14 days after randomization. After 14 days, researchers decided whether to take uric-lowering therapy according to uric acid level. In principle, allopurinol was not used for uric-lowering therapy.
• (3) Patients who took ULT before randomization but did not stabilize for 14 days were not allowed to take urico-lowering therapy within 14 days after randomization, and the researchers decided whether to take urico-lowering therapy after 14 days according to the uric acid level. In principle, patients who had not used allopurinol before should not use allopurinol for urico-lowering therapy in this study.

You may not qualify if:

• 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;
• Continued treatment with systemic immunosuppressive agents for 3 months prior to screening.
• There are active bleeding diseases of internal organs, or there is a serious bleeding tendency (such as hemophilia, etc.), or anti-coagulation treatment with heparin;
• Those diagnosed with secondary gout (e.g. chemotherapy-induced gout, lead-induced gout, transplantable gout, etc.Except for gout caused by impaired renal function);
• Diagnosis or suspicion of rheumatoid arthritis, infectious/septic arthritis, the presence of other conditions that may confuse the assessment of the affected joint, such as the presence of other pain, including but not limited to nerve disease, nerve root compression due to disc herniation, shingles, sciatica, etc.;
• There are infections requiring systemic drug control within 7 days prior to screening;
• Have received live or attenuated vaccines within 3 months prior to screening, or plan to receive live or attenuated vaccines during the study period;
• Those who received COVID-19 vaccine within 2 weeks prior to screening;

Sponsors & Collaborators

• Lihua Duan: lead

Study Sites (1)

Department of Rheumatology and Clinical Immunology, Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lihua Duan, MD

  Jiangxi Provincial People's Hopital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of rheumatology and immunology

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 29, 2023
• Study Start: September 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: January 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)