Gout
Conditions
Interventions
Exposure group:None
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Those who can voluntarily sign the informed consent form and are willing to cooperate with the completion of the trial as per the protocol; 2.Age >= 10 years old, both male and female are eligible; 3.Patients diagnosed with gout according to the 2015 American College of Rheumatology (ACR) classification criteria for gout; 4.Had >= 2 acute gout attacks within 1 year prior to screening; 5.The current acute gout attack occurred within 5 days before the screening period; 6.The pain degree of the target joint during the screening period was >= 50mm on the VAS scale (VAS 0-100mm) (See Appendix II for VAS pain score); 7.Willing to follow the protocol's regulations for uric acid-lowering treatment (ULT) during the study period, and meet one of the following conditions: (1) Patients currently receiving ULT and have been on stable treatment for = 14 days. During the trial, the stable dosing regimen must be maintained for at least 12 weeks, unless the investigator assesses that the patient is intolerant to the original ULT regimen, or the treatment is ineffective, or the uric acid level has reached the target, in which case the ULT regimen can be adjusted, including changing the drug, reducing the dose, or discontinuing the treatment; (2) Patients who have not used ULT before enrollment are not allowed to take ULT within 14 days after enrollment. After 14 days, the investigator will decide whether to take ULT based on the uric acid level; (3) Patients who have used ULT but have not been on stable treatment for 14 days before enrollment are not allowed to take ULT within 14 days after enrollment. After 14 days, the investigator will decide whether to take ULT based on the uric acid level.
Exclusion criteria
Exclusion criteria: 1.Those who have received any of the following drugs or treatments within the specified time periods: - Ibuprofen or acetaminophen within 4 hours before enrollment; - Diclofenac, tramadol, or local ice packs/cold packs within 6 hours before enrollment; - Celecoxib, naproxen, lornoxicam, codeine, or colchicine within 12 hours before enrollment; - Prednisone = 10 mg or equivalent doses of corticosteroids within 24 hours before enrollment; - Meloxicam, etoricoxib, or other short-acting analgesics within 24 hours before enrollment; - Long-acting opioid treatment within 14 days before screening; - Intra-articular injection of glucocorticoids within 14 days before screening; - Prednisone >= 5 mg/day or equivalent doses of corticosteroids for more than 28 days within 12 weeks before screening or for more than 14 consecutive days before screening; - Any IL-1 blocker, TNF inhibitor, or other biologics within 30 days before screening or within 3 half-lives (whichever is longer, or as per local regulations); - Systemic immunosuppressants within 1 month before screening. 2.Those with an infection requiring systemic treatment within 3 days before screening; 3.Those who have received live or attenuated live vaccines within 3 months before screening, or have received the COVID-19 vaccine within 2 weeks before screening, or plan to receive live or attenuated live vaccines during the study period; 4.Those who meet any of the following conditions: (1) Confirmed active tuberculosis infection, including but not limited to active tuberculosis infection confirmed by imaging; (2) Those in the latent tuberculosis infection stage or with high-risk factors for tuberculosis infection can be included, but patients deemed unsuitable for inclusion by the investigator, such as those unwilling to continue anti-TB treatment according to local guidelines after entering the trial, should be excluded; 5.Those with abnormal laboratory values during the screening period: - White blood cell count or absolute neutrophil count below the lower limit of normal at the research center; - PLT 1.5 × ULN, AST > 5 × ULN, ALT > 5 × ULN; serum albumin 5.7 mmol/L; 6.Women with positive blood HCG during the screening period; lactating women; 7.Female subjects who do not agree to use adequate and effective contraceptive measures from signing the informed consent form to 6 months after the last dose of study drug, except for those who are postmenopausal or have undergone hysterectomy; 8.Those who have used investigational drugs or participated in other clinical trials within 1 month before screening; 9.Those with a history of drug abuse and/or mental disorders; 10.Those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate of gout within six months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the VAS score (0-100mm) of the target joint pain at 72 hours compared to the baseline.;Adverse event; | — |
Countries
China
Contacts
Public ContactSun Xuehui
Yantai Yuhuangding Hospital
Outcome results
None listed