Gout Arthritis
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.
Interventions
DRUGRecombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
Subjects will receive one s.c. injection of SSGJ-613 on Day 1.
DRUGColchicine 0.5 mg
Subjects will receive 0.5mg/d Colchicine for 12 weeks.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must be 18 Years to 75 Years, both male and female. * BMI ≤40 kg/m2. * Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis. * ≥2 acute gout flares within 1 year prior to screening. * Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.
Exclusion criteria
* Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc. * Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. * Presence of severe renal function impairment. * Intolerance of subcutaneous injection. * Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment. * Live vaccinations within 8 weeks prior to the start of the study. * Use of forbidden therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of acute gout flares | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of subjects with at least 1 acute gout flare | 12 weeks | — |
| Time from randomization to first acute flare. | 24 weeks | — |
| Duration of acute gout flares. | 12 weeks | — |
| Numbers of acute gout flares | 24 weeks | — |
| Investigator's overall assessment of response to treatment | 24 weeks | Response to treatment will be assessed by the Investigators using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor. |
| 36-item Short Form Survey (SF-36) | 24 weeks | 36-Item Short Form Survey (SF-36) will be used to assess the health and functional changes of the subjects. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. |
| Adverse events (AE) | 24 weeks | — |
| Subject's overall assessment of response to treatment | 24 weeks | Response to treatment will be assessed by the subjects using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor. |
Countries
China
Outcome results
None listed