Safety & Efffficacy of Genakumab in Patients With Frequent Flares
NCT ID: NCT05983445
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2023-01-11
2024-04-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Genakumab
Genakumab 200mg s.c
genakumab
200mg s.c.
placebo for Diprospan
i.m.
Diprospan
Diprospan 7mg im
placebo for genakumab
s.c.
Diprospan
7mg i.m.
Interventions
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genakumab
200mg s.c.
placebo for Diprospan
i.m.
placebo for genakumab
s.c.
Diprospan
7mg i.m.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
75 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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GenSci048-301
Identifier Type: -
Identifier Source: org_study_id