Acute Gout Arthritis
Conditions
Keywords
Acute Gout Arthritis
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 gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.
Interventions
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first new flare | 12 weeks | — |
| The change in the gout pain intensity in the target joint measured by VAS | 72 hours post-dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in the gout pain intensity in the target joint measured by VAS. | At 6, 24, 48, and 72 hours and 7 days post-dose | — |
| The number of patients with at least 1 new gout flare | 12 weeks, 24 weeks, 48 weeks | — |
| Time to at Least a 50% Reduction in Baseline Pain Intensity | 7 days | — |
| Time to first flare | 24 weeks, 48 weeks | — |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 24weeks, 48weeks | — |
| Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody | 24 weeks, 48 weeks | — |
| Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period | 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose | Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose. |
| Percent Patients Who Took Rescue Medication | 24 weeks,48 weeks | — |
| Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm) | At 6, 24, 48, and 72 hours and 7 days post-dose | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| High Sensitivity C-reactive Protein (hsCRP) | 72 hours, 7 days and 4 weeks post-dose | — |
| SF-36 | 8 weeks, 24 weeks and 48 weeks | The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates. |
Countries
China
Outcome results
None listed