Trial reportInternational journal of rheumatic diseases2026
SSGJ-613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double-Blind, Phase II Study.
Trial report in International journal of rheumatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06169891 (A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Who cites it
1 citing paper in PubMed.
- Antibodies to watch in 2025.mAbs · 2025Review
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Authors and funding
17 authors.
Funding
Abstract
objectivesThis phase II trial aimed to evaluate the efficacy and safety of SSGJ-613, a fully human anti-interleukin 1β monoclonal antibody, compared with compound betamethasone (CB) in Chinese patients with acute gouty arthritis.
methodsIn this multicenter, double-blind, double-dummy, active-controlled study, 90 adults with gout according to the 2015 American College of Rheumatology (ACR) criteria and who had experienced an acute gouty arthritis flare within 7 days were randomized (1:1:1) to receive a single subcutaneous injection of SSGJ-613 (200 mg or 300 mg) or intramuscular CB. The primary endpoint was the change from baseline in visual analog scale (VAS) pain scores at 72 h post-dosing. Safety was evaluated through monitoring of adverse events and laboratory parameters.
resultsThe mean changes from baseline in VAS scores at 72 h were comparable between SSGJ-613200 mg (-45.8 mm), 300 mg (-40.4 mm), and CB (-48.2 mm) groups. However, SSGJ-613 significantly reduced the risk of new flares: 16.7% (200 mg) and 14.3% (300 mg) of patients experienced new flares versus 54.8% with CB (p = 0.0037 and p = 0.0019, respectively). The safety profile of SSGJ-613 was similar to CB, with no drug-related serious adverse events reported.
conclusionA single injection of SSGJ-613 demonstrated rapid pain relief comparable to corticosteroid therapy at 72 h and provided superior protection against gout flare recurrence over 12 weeks in Chinese patients, supporting its potential as an effective treatment option for acute gouty arthritis with prolonged therapeutic benefits. CLINICAL TRIALS: NCT06169891.
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