Gout, Gout Initiating Urate-loweringUrate-lowering Therapy
Conditions
Keywords
Gout, urate-loweringUrate-lowering therapy
Brief summary
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
Detailed description
A randomized, open-lable, multi-center, active-controlled Phase 2 study. Patients are randomized to Genakumab 100mg single injection group, Genakumab 200mg single injection group or oral colchicine 0.5mg once a day.for 12 weeks group.
Interventions
150 mg/1ml/ vial
DRUGColchicine
0.5 mg/table
Sponsors
Huashan Hospital
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Gout patients initiating urate-lowering therapy Group A: Genakumab 100mg single injection; Group B: Genakumab 200mg single injection;Group C: Oral colchicine 0.5mg once a day for 12 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent before any study procedure is performed. 2. Male or female, 18 years ≤ age ≤ 75 years. 3. BMI ≤ 40kg/m2. 4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout. 5. History of ≥2 gout flare within 12 months prior to screening. 6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Gout Flares Per Participant | Baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants With at Least 1 Gout Flare Within 12 Weeks After Randomization | Baseline to Week 12 |
| Time from Randomization to the First Flare | Baseline to Week 12 |
| Mean duration of flares | Baseline to Week 12 |
| 5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline to Week 12 |
Other
| Measure | Time frame |
|---|---|
| 6. Immunogenic Outcome The incidence of anti-drug antibodies and the incidence of neutralizing antibody | Baseline to Week 12 |
Countries
China
Outcome results
None listed