To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy
Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
150 mg/1ml/bottle
0.5mg/table
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
72hours target joint VAS change from baseline
72hours target joint VAS change from baseline
Time frame: 72h±2h
Pain intensity
target joint VAS Target joint VAS change from baseline Time to first VAS\<=50% baseline VAS Time to first VAS\<=30mm Time to first VAS\<=10mm
Time frame: 6hours, 24hours, 48hours, 72hours, Day 8,
Recurrence of flare
Proportion of patients who have at least 1 flare Time to first flare
Time frame: 12 weeks after the last dose
Safety outcome
AE, laboratory examination, ECG, vital signs and physical examination
Time frame: 12weeks
immunogenic outcome
The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody
Time frame: 12 weeks after the last dose
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