Gout
Conditions
Interventions
Firsekibart group:None
Diprospan group:None
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Those who are able to voluntarily sign an informed consent form and voluntarily cooperate to complete the trial in accordance with the protocol 2. 18 years = 2 episodes of Gouty Arthritis in the 1 year before screening, which met the definition of refractory gout first proposed in the Chinese Hyperuricemia and Gout Diagnosis and Treatment Guidelines (2019), those who met any of the following definitions: (1) sufficient dose and duration of treatment with conventional uric acid-lowering drugs alone or in combination, but still >= 360 µmol/L of serum uric acid; (2) receiving standardized treatment, but still having >= 2 gout attacks per year; (3) the presence of multiple or progressive tophi 6. Patients eligible for surgical intervention 7. Willingness to follow protocol provisions for uric acid-lowering therapy (ULT) during the study period, meeting one of the following conditions: (1) the patient was receiving ULT and stable treatment for > 14 days, and a stable dosing regimen should be maintained for at least 14 days while participating in the trial, unless intolerance, poor response, or low uric acid levels in patients who had been evaluated by the investigator for previous uric-acid-lowering regimens occurred, adjustments to the uric acid-lowering regimen could be permitted, including drug change, reduction, or discontinuation; (2) patients who did not use an ULT before dosing were not allowed to take uric acid-lowering therapy for 14 days after dosing, and after 14 days, uric acid levels were used by the investigator to decide whether or not to take uric acid-lowering therapy; (3) patients who used ULTs before dosing but were not stable for 14 days were not allowed to take uric acid-lowering therapy for 14 days after dosing; after 14 days, uric acid levels were used by the investigators to decide whether to take uric acid-lowering therapy; (4) patients were asked to take uric acid-lowering therapy at the same time as they were not allowed to take other drugs to prevent the onset of gouty arthritis; such as oral low-dose glucocorticoid, non-steroidal anti-inflammatory drug (NSAID) or colchicine
Exclusion criteria
Exclusion criteria: 1. Known allergies or contraindications to any of the drugs planned for use (e.g. . Glucocorticoid, vosintuzumab) or to any of the ingredients of such drugs 2. Long-acting opioid therapy was used within 14 days before screening, intra-articular glucocorticoid was administered within 14 days before screening, and more than 28 consecutive or cumulative days were used within 12 weeks before screening, or received =5 mg/d of prednisone (or equivalent) continuously for 14 days prior to screening; used any IL-1 beta blocker, TNF inhibitor, or other biologic within 30 days or 3 half-lives prior to screening; Continuous systemic administration of immunosuppressive drug (IS) for 3 months prior to screening 3. Patients with active bleeding disease of internal organs, severe bleeding tendency, or anticoagulant therapy with heparin 4. In patients diagnosed with secondary gout (e.g. , chemotherapy-induced gout) , there are other conditions that may confound the assessment of the affected joint 5. Infections requiring systemic control within 7 days before screening 6. Those who received a live injection or live attenuated vaccine within 3 months before screening, or who planned to receive a live or live attenuated vaccine during the study period, or a covid-19 vaccine within 2 weeks before screening 7. Cancer within 5 years before screening, except for treated or resected skin basal-cell carcinoma or stage I squamous cells, previous treatment with total body irradiation or total lymphatic irradiation, previous cell therapy or any type of bone marrow transplant previous solid organ transplant 8. Patients with a history of severe immunodeficiency, combined with severe primary diseases of the cardiovascular and cerebrovascular systems, digestive and hematopoietic systems, and patients with psychiatric disorders and disorders of consciousness 9. Those who met one of the following criteria: (1) confirmed active tuberculosis infection, including but not limited to radiographically confirmed active tuberculosis infection; and (2) were in latent tuberculosis infection or had risk factors for infection were enrolled, patients deemed unsuitable for enrollment by the investigators, such as those unwilling to continue anti-TB treatment according to local guidelines after entering the trial, should be excluded 10. Those on renal dialysis, or eGFR < 30 ml/min/1.73 m^2 11. Pregnant women, lactating women and men or women who had Planned Parenthood during the trial period 12. Subjects were judged by the investigators to be unfit for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to gout recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| The pain VAS score (0-100 mm) was used to evaluate the degree of pain in the affected joints at baseline in both groups;Health Survey Short Form (SF-36-RRB- scores were used to assess the ability of patients in both groups to perform routine activities of daily living;The pain VAS score (0-100 mm) was used to evaluate the changes of the involved joint pain in the two groups;Post-dose pain VAS scores (0-100 mm) were used to assess the time to the first decrease in pain to =50% of baseline in the affected joints in both groups;The ratio of salvage treatment and the dosage of drugs used were compared between the two groups;Changes of post-operative inflammatory markers compared with baseline;Number of gout flares within 12 and 24 weeks;Safety measures: adverse events, clinical safety laboratory tests, electrocardiograms, vital signs, and routine physical examinations; | — |
Countries
China
Contacts
Public ContactJie Ligang
Zhujiang Hospital of Southern Medical University
Outcome results
None listed