It is a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanized monoclonal antibody injection in subjects with acute gout flare
Understand and sign the informed consent form;
Aged 18 to 75 years, male or female, male or female;
Body Mass Index (BMI) between 18.0 kg/m² and 40.0 kg/m²;
Meets the 2015 American College of Rheumatology (ACR) Gout Classification Criteria;
None
Parallel
Compound Betamenth Group
DrugIntramuscular injection 2ml/bottle
IBI3011 GROUP
DrugSubcutaneous injection 300mg/bottle
The change in the gout pain intensity in the target joint measured by VAS
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
The change in the gout pain intensity in the target joint measured by VAS.
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
The number of patients with at least 1 new gout flare
Time to at Least a 50%，70% Reduction in Baseline Pain Intensity
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
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