Gouty Arthritis
Conditions
Interventions
Treatment group:Genakumab for Injection 200mg sc. + Compound Betamethasone Injection matching placebo 1ml im.
Control group:Compound betamethasone injection 7mg im.+Genakumab matching placebo for injection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Those who are able to voluntarily sign the informed consent form and voluntarily cooperate in completing the trial according to the protocol; 2. 18 years = 2 acute flares of gout within 1 year prior to screening; 6. Current acute gout flare occurred within 4 days prior to screening; 7. Target joint pain VAS >= 50 mm (VAS 0-100 mm) at screening; 8. Evidence of contraindication, intolerance, or lack of efficacy to NSAIDs and/or colchicine; 9. Willingness to comply with protocol-specified uric acid-lowering therapy (ULT) during the study, with one of the following: (1) Patients receiving ULT and have been on stable treatment for >= 14 days must maintain a stable dosing regimen for at least 12 weeks during the study unless the investigator determines that the patient with the existing regimen develops intolerance, inadequate efficacy, or low uric acid levels, in which case adjustments including switching medications, dose reduction, or discontinuation are permitted; (2) Patients who did not use ULT before randomization were not allowed to take ULT within 14 days after randomization, and 14 days later, the investigator decided whether to take ULT according to uric acid level. Allopurinol was not selected for uric acid lowering therapy in principle; (3) Patients who used ULT before randomization but were not stable for 14 days were not allowed to take ULT within 14 days after randomization. After 14 days, the investigator decided whether to take ULT based on uric acid level, and in principle, patients who had not previously used allopurinol could not choose allopurinol for ULT in this study.
Exclusion criteria
Exclusion criteria: 1) History of allergic reactions to the study drug or drugs of the same class; 2) Receiving any of the following medications or therapeutic measures: – Use of ibuprofen or paracetamol within 4 hours prior to randomization; – Use of diclofenac, tramadol, or local ice/freezer packs within 6 hours prior to randomization; – Use of celecoxib, naproxen, loxoprofen, compound ibuprofen and codeine, or colchicine within 12 hours prior to randomization; – Use of = 10 mg prednisone or equivalent within 24 hours prior to randomization; – Use of meloxicam, etoricoxib, or other short-acting analgesic within 24 hours prior to randomization; – Use of long-acting opioids 14 days prior to screening; – Use of intra-articular glucocorticoids 14 days prior to screening; – A cumulative total of more than 28 days of corticosteroid use within 12 weeks prior to screening, or a continuous daily dose of =5 mg prednisone (or equivalent corticosteroid doses) within 14 days prior to screening; – Use of any IL-1 blocker, TNF inhibitor, or other biologic within 30 days or 3 half-lives (whichever is longer, or as per local regulations) prior to screening; – Continuous use of systemic immunosuppressant therapy within 3 months prior to screening. 3) Presence of active bleeding diseases of internal organs, or with severe bleeding tendency (such as hemophilia, etc.), or receiving anticoagulant therapy with heparin; 4) Diagnosis of secondary gout (e.g., chemotherapy-induced gout, lead-induced gout, transplant-related gout, etc., except gout caused by impaired renal function); 5) Diagnosis or suspicion of rheumatoid arthritis, infection/septic arthritis, or presence of other conditions that may confound the assessment of the affected joint, eg, presence of other pains, including but not limited to neurological disorders, nerve root compression due to disc herniation, herpes zoster, sciatica, etc; 6) Presence of infections requiring systemic medication for control within 7 days prior to screening; 7) Receiving a live or live-attenuated vaccine within 3 months prior to screening or planning to receive a live or live-attenuated vaccine during the study; 8) Receiving coronavirus vaccine within 2 weeks prior to screening; 9) Diagnosis or within 5 years prior to screening, except adequately treated or excised basal cell or Stage I squamous cell carcinoma of the skin: 10) Prior total body irradiation or total lymphoid irradiation; prior stem cell therapy or any type of bone marrow transplant; prior solid organ transplant; chronic systemic immunosuppressant therapy; 11) History of serious immunodeficiency, including positive human immunodeficiency virus (HIV) antibody; or other acquired, congenital immunodeficiency disease; 12) Presence of clinically significant disease: – Patients with a history of chronic congestive heart failure, cardiac function NYHA IV; patients with a history of cardiac ejection fraction (EF) less than 30% detected by echocardiography; – Patients who experienced myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; patients who underwent coronary revascularization within 6 months; – Presence of serious cardiac arrhythmia requiring treatment with class Ia or III antiarrhythmic drugs; presence of sick sinus syndrome, II degree Type II or III atrioventricular block arrhythmia and no pacemaker has been implanted; – Electrocardiogram showed QTc interval = 480 ms (according to Fridericia correction formula, where Q
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS pain score (0-100mm) in the target joint from baseline;Time to first new gout flare from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS pain score (0-100mm) in the target joint;Change in VAS pain score (0-100mm) in the target joint from baseline;Time to first reduction of VAS pain score (0-100mm) to =50% of baseline in the target joint;Proportion of patients requiring rescue therapy during double-blind and open-label treatment periods;Dosage of rescue medications used during double-blind and open-label treatment periods;Proportion of patients experiencing at least one new gout flare during each treatment period;Mean number of acute gout flares per patient during each treatment period;Time to first new gout flare from baseline during each treatment period;Safety;Incidence of anti-drug antibodies (ADA);Incidence of neutralizing antibodies (Nab);Population characteristics of pharmacokinetics; | — |
Countries
China
Contacts
Public ContactZou Hejian
Huashan Hospital, Fudan University
Outcome results
None listed