The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
one s.c. injection of SSGJ-613 once, on Day 1.
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
1 mL i.m. once on Day 1
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: 72 hours post-dose
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.
Time frame: 12 weeks
The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 6, 12, 48 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: At 6, 24, 48 hours and 7 Days post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration
The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).
Time frame: Up to 48 weeks
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
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Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Time frame: Up to 48 weeks
Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Time frame: 12 weeks
Time to first use of Rescue Medication
The Kaplan Meier method was used to estimate the median time and 95% CI of the first use of Rescue Medication.
Time frame: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
Time frame: 12 weeks, 24 weeks, 48 weeks
Likert scores for target joint pain
Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Time frame: 7 days, 12 weeks, 24 weeks
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares after the first administration of each group, as well as the event incidence and 95% CI.
Time frame: 24 weeks, 48 weeks
Percentage of Participants with at least 1 new gout flare
Time frame: 12 weeks, 24 weeks, 48 weeks
Number of new gout flares
Time frame: 12 weeks, 24 weeks, 48 weeks