Gouty Arthritis
Conditions
Interventions
Treatment group:firsekibart
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and comply with the study protocol; 2. Age >=65 years, any gender; 3. Meets the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria; 4. Currently experiencing an acute gouty arthritis flare (pain onset =50 mm (0–100 mm);
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational product or any excipients, or a severe allergic constitution; 2. Prior treatment with any biologic therapy targeting IL-1ß; 3. Active infection (e.g., tuberculosis, hepatitis B, hepatitis C, HIV) or a history of recurrent infections; 4. Severe or poorly controlled cardio-cerebrovascular, hepatic, renal, hematologic, neurologic diseases, or malignancies; 5. Any other condition deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in inflammatory markers (ESR and CRP);Patient Global Assessment of pain response (PtGA) and Physician/Investigator Global Assessment of disease activity (PhGA) using a 5-point Likert scale;Change from baseline in target-joint pain VAS ;Safety Assessment;recurrence rate of acute flares, time to recurrence, and recurrence frequency; | — |
Countries
China
Contacts
Public ContactLin Wei
Hebei General Hospital
Outcome results
None listed