Gouty Arthritis
Conditions
Interventions
Experimental Group:Preoperatively, 200 mg of Vunakizumab was administered subcutaneously, along with daily oral colchicine 0.5 mg.
Control Group:Oral colchicine 0.5 mg daily
Sponsors
The Fifth Hospital of Xi'an
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to voluntarily sign the informed consent form and willing to comply with the protocol throughout the trial; 2. Diagnosed with gout according to the 2015 American College of Rheumatology (ACR) classification criteria for gout; 3. Age >=18 years, regardless of gender; 4. Has surgical indications for tophus removal, specifically as follows: (1) Impairment of daily living functions: Tophi cause persistent pain in joints and surrounding tissues, significantly affecting the patient’s quality of life and impairing basic activities (e.g., walking, standing, dressing, climbing stairs). Surgical intervention can effectively alleviate symptoms and improve quality of life. (2) Bone, joint, and tendon destruction: Long-standing tophi induce chronic local inflammation, progressively leading to articular surface damage, cartilage erosion, and tendon injury. This manifests as joint swelling, deformity, restricted mobility, and even complete loss of joint function. Surgery not only relieves pain but also helps repair damaged tissues, restore joint function, and prevent further structural deterioration. (3) Frequent acute gout flares: Patients experiencing multiple acute gout attacks within a short period (e.g., more than three episodes within one month) indicate poor disease control. When pharmacological treatment fails to adequately relieve symptoms, surgical removal of tophi may reduce flare frequency and lower the risk of recurrent pain, thereby alleviating the overall disease burden. (4) Ineffectiveness or intolerance to medical therapy: In some cases, patients develop resistance to or experience intolerable side effects from conventional medications (e.g., NSAIDs, glucocorticoids, urate-lowering therapies), rendering pharmacological management inadequate. Surgery serves as an effective adjunctive approach by directly removing tophi, reducing local inflammation, and restoring joint function. (5) Poorly controlled or persistently elevated serum uric acid levels: Patients with chronically high uric acid levels that cannot be managed with medication are at increased risk of tophus deposition and progressive joint destruction. When non-surgical strategies fail to control the condition, surgical intervention becomes essential. (6) Presence of complications: Tophi may lead to secondary complications such as joint infection or deep vein thrombosis. In cases where uncontrolled disease poses a threat to the patient’s health or life, surgical removal of the lesion is necessary to prevent further complications. (7) Patient request: Some patients suffer prolonged, severe pain and functional limitations due to tophi and strongly desire surgical improvement in their quality of life. If surgical criteria are met and a favorable postoperative outcome is anticipated, surgery may be offered; 5. Patients requiring surgery related to gout;
Exclusion criteria
Exclusion criteria: 1. a history of allergic reaction to the study drug or a comparable drug; 2. have received any of the following medications or treatments: ibuprofen, acetaminophen within 4 hours prior to randomisation; diclofenac, tramadol, or topical ice packs/freezer packs within 6 hours prior to randomisation; naproxen, loxoprofen, lofenadine within 12 hours prior to randomisation; >=10 mg of prednisone or equivalent within 24 hours prior to randomisation; etoricoxib, celecoxib, or meloxicam or other short-acting pain medication within 24 hours prior to randomisation; or Use of etoricoxib, celecoxib, meloxicam, or other short-acting pain medication within 24 hours prior to randomisation; Long-acting opioid therapy within 14 days prior to screening; Intra-articular glucocorticosteroid therapy within 14 days prior to screening; Predominant treatment with prednisone (or corticosteroid equivalent) for more than 28 cumulative days in the 12 weeks prior to screening, or continuously for more than 14 days prior to screening >= 5 mg/d; Use of any IL-1 blocker, TNF inhibitor, or other biological agent within 30 days or 3 half-lives (whichever is longer, or as required by local regulations) prior to Screening; Continuous immunosuppressive therapy via systemic administration within 3 months prior to Screening. 3. the presence of active bleeding disorders of internal organs, or severe bleeding tendency (e.g. haemophilia), or the need for anticoagulant therapy (including drugs such as heparin, aspirin, etc.); 4. those with a combination of other active arthritis (e.g. rheumatoid arthritis, infectious arthritis, etc.) that may interfere with the assessment of pain and recurrence; 5. infections requiring control with systemic medication within 7 days prior to screening; 6. have received a live or live attenuated vaccine within 3 months prior to screening or plan to receive a live or live attenuated vaccine during the study; 7. cancer within 5 years prior to screening, except adequately treated or excised basal cell carcinoma of the skin or stage I squamous cell carcinoma; 8. previous treatment with total body irradiation or total lymphatic irradiation; previous stem cell therapy or bone marrow transplantation of any type; previous solid organ transplantation; long-term systemic treatment with immunosuppressive agents; 9. Combination of other major diseases: uncontrolled severe cardiovascular disease (recent heart attack, heart failure NYHA class III/IV, etc.), post-stroke sequelae, active peptic ulcer; severe hepatic impairment (ALT/AST more than 3 times the upper limit of normal) or stage IV or higher renal insufficiency (eGFR < 15 ml/min); 10. pregnant or lactating females; 11. conditions that, in the judgement of the investigator, render the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of acute gout attacks within 7 days after the surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity and duration of the pain during a recurrence of gout;The proportion of patients with at least one recurrence during the follow-up period and the average number of recurrences per patient;Safety; | — |
Countries
China
Contacts
Public ContactHua Guo
The Fifth Hospital of Xi'an
Outcome results
None listed