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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genacumab group | Experimental | Genakumab 200mg single injection |
|
| cholchicine group | Active Comparator | Colchicine 0.5mg qd po.for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genakumab for injection | Drug | 150 mg/1ml/bottle |
| |
| Colchicine |
| Measure | Description | Time Frame |
|---|---|---|
| 72hours target joint VAS change from baseline | 72hours target joint VAS change from baseline | 72h±2h |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6hours, 24hours, 48hours, 72hours, Day 8, |
| Recurrence of flare |
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| Name | Affiliation | Role |
|---|---|---|
| Hejian Zou | Fudan University Affiliated Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Huashan Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40833487 | Derived | Kong N, Xue Y, Mao L, Qian L, Guo H, Hu J, Yuan F, Li R, Duan X, Yu J, Gou W, Yang L, Wei H, Li R, Xu Q, Luo T, Zhang X, Zou H. Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatol Ther. 2025 Oct;12(5):975-990. doi: 10.1007/s40744-025-00790-6. Epub 2025 Aug 20. |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000470 | Alkaloids |
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Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)
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| Drug |
0.5mg/table |
|
Proportion of patients who have at least 1 flare Time to first flare
| 12 weeks after the last dose |
| Safety outcome | AE, laboratory examination, ECG, vital signs and physical examination | 12weeks |
| immunogenic outcome | The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | 12 weeks after the last dose |
| D006571 |
| Heterocyclic Compounds |