Status:
COMPLETED
Safety & Efffficacy of Genakumab in Patients With Frequent Flares
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Acute Gout Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).
Detailed Description
A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gout...
Eligibility Criteria
Inclusion
- Male or female, 18 years ≤ age ≤75 years
- BMI≤40kg/m2
- Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout.
- Start of acute gout flare within 4 days prior to enrolled
- History of ≥ 2 gout flares within the 12 months prior to study start
- Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
- Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
Exclusion
- \-
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT05983445
Start Date
January 11 2023
End Date
April 3 2024
Last Update
December 18 2024
Active Locations (1)
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1
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China