Acute GoutNCT05925166
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout
A study testing rhTNFR-Fc and methylprednisolone in people with Acute Gout, run by Lihua Duan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Gout
- What is being tested?
- rhTNFR-Fc and methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- We are willing to follow the protocol of uric acid lowering therapy (ULT) during the study period and meet the following conditions One:
- 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.
- 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.
Who cannot join
- 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;
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- 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;
- Cancer within 5 years prior to screening:
- A history of severe immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases;
- Presence of the following clinically significant diseases:
- Patients with a history of chronic congestive heart failure and NYHA level IV cardiac function; Patients with a history of cardiac ejection fraction (EF) less than 30% detected by echocardiography;
- Patients with myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Patients who underwent coronary revascularization within 6 months; C. The presence of severe arrhythmias requiring Class Ia or III antiarrhythmic drugs; Arrhythmias with diseased sinus syndrome, grade II type II or grade III atrioventricular block, and no pacemaker implanted;
- TB T-SPOT or γ interferon release test positive or have a previous history of TB;
- Hepatitis B surface antigen positive ;
- Receive kidney dialysis treatment;
- There are the following abnormalities in the laboratory test values during the screening period:
- White blood cell count ≤3×109 /L or neutrophil absolute value ≤1.5×109 /L;
- PLT≤100×109 /L;
- Total bilirubin >1.5×ULN, alanine aminotransferase (AST) >3×ULN, aspartate aminotransferase (ALT) >;3×ULN;
- Estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2;
- Pregnant or nursing (lactating) women;
- Female patients who are biologically capable of becoming pregnant must use an acceptable method of contraception;
- A history of drug and/or alcohol abuse or mental disorders;
- It is determined by the investigator that the subject has a history of certain diseases that are not suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Clinical Immunology, Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330000
About this study
Official title: Safety and Efficacy of Of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein In Acute Gout
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.
Read the 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
- Being tested
- rhTNFR-Fc, methylprednisolone
- Keywords
- rhTNFR-Fc、Acute Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNFR-FcDrug
Also called etanercept、Yisaipu
Subjects will receive a dose of 25mg twice in 5 days(day 1 and the day 3).
Subjects will be administered methylprednisolone 20 mg intravenous.
| Study group | Role | What they receive |
|---|---|---|
| rhTNFR-Fc | Experimental | Subjects will be administered rhTNFR-Fc 50 mg subcutaneously Receives: Drug: rhTNFR-Fc |
| methylprednisolone | Active comparator | Subjects will be administered methylprednisolone 20 mg intravenous Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 day
Acute gout recurrence time
Time from baseline to first acute gout recurrence
Measured: within 4 weeks
Secondary outcomes (6)
Joint pain on numeric pain scale
Patient's assessment of joint pain intensity in the most affected baseline joint on a 0-10 pain scale, at Baseline and post-dose Days
Measured: Days 5
Patient's assessment of response to treatment
Patient's global assessment of response to treatment
Measured: Day 5
Physician's assessment of response to treatment
Physician's global assessment of response to treatment
Measured: Day 5
Rescue Medication
Compare the use of rescue medication
Measured: Day 5
Safety and Tolerability of rhTNFR-Fc
Safety and tolerability as assessed by subjects with adverse events and serious adverse events from baseline through Visit 5 safety follow-up
Measured: Day 5
inflammatory index change
Inflammatory index 1 week after treatment: change from baseline
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Sep 2020
- Primary completion1 Jul 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lihua Duan, Jiangxi Provincial People's Hopital
- Investigators
- Lihua Duan, MD, Principal investigator, Jiangxi Provincial People's Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925166
- Sponsor's protocol ID
- DLH86895639
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein In Acute Gout
- ClinicalTrials.gov ID
- NCT05925166
- Acronym / sponsor ID
- DLH86895639
- Conditions
- Acute Gout
- Keywords
- rhTNFR-Fc、Acute Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lihua DuanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTNFR-Fc | Experimental | Drug: rhTNFR-FcSubjects will be administered rhTNFR-Fc 50 mg subcutaneously |
| methylprednisolone | Active comparator | Drug: methylprednisoloneSubjects will be administered methylprednisolone 20 mg intravenous |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (32 listed)
- 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:
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTNFR-FcAlso: etanercept、YisaipuSubjects will receive a dose of 25mg twice in 5 days(day 1 and the day 3). | Drug | rhTNFR-Fc |
| methylprednisoloneSubjects will be administered methylprednisolone 20 mg intravenous. | Drug | methylprednisolone |
Primary outcome
Joint pain intensity in the most affected joint
Time frame: 5 day
Pain intensity in the most affected baseline joint measured by the numeric 0-10 pain scale at 72 hours
Acute gout recurrence time
Time frame: within 4 weeks
Time from baseline to first acute gout recurrence
6 secondary outcomes
Joint pain on numeric pain scale
Time frame: Days 5
Patient's assessment of response to treatment
Time frame: Day 5
Physician's assessment of response to treatment
Time frame: Day 5
Rescue Medication
Time frame: Day 5
Safety and Tolerability of rhTNFR-Fc
Time frame: Day 5
inflammatory index change
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lihua Duan, MD principal investigator
Jiangxi Provincial People's Hopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhTNFR-Fc and methylprednisolone in people with Acute Gout, run by Lihua Duan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint pain intensity in the most affected joint (time frame: 5 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.