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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSGJ-613 100 mg | Experimental | Subjects will receive 100mg SSGJ-613 on Day 1. |
|
| SSGJ-613 200 mg | Experimental | Subjects will receive 200mg SSGJ-613 on Day 1. |
|
| Colchicine 0.5mg | Active Comparator | Subjects will receive 0.5mg/d Colchicine for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg | Drug | Subjects will receive one s.c. injection of SSGJ-613 on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of acute gout flares | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of acute gout flares | 24 weeks | |
| Proportions of subjects with at least 1 acute gout flare | 12 weeks | |
| Proportions of subjects with at least 1 acute gout flare |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hejian Zou, MD | Shanghai Huashan Hospital Fudan University-Rheumatology | Principal Investigator |
| Qinghong Zhou | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huashan Hospital Fudan University-Rheumatology | Shanghai | Shanghai Municipality | 200040 | China |
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| Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg | Drug | Subjects will receive one s.c. injection of SSGJ-613 on Day 1. |
|
|
| Colchicine 0.5 mg | Drug | Subjects will receive 0.5mg/d Colchicine for 12 weeks. |
|
| 24 weeks |
| Time from randomization to first acute flare. | 24 weeks |
| Duration of acute gout flares. | 12 weeks |
| Duration of acute gout flares. | 24 weeks |
| Subject's overall assessment of response to treatment | 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. | 24 weeks |
| Investigator's overall assessment of response to treatment | 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. | 24 weeks |
| 36-item Short Form Survey (SF-36) | 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. | 24 weeks |
| Adverse events (AE) | 24 weeks |
| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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