Refractory Gout
Conditions
Interventions
Treatment Group:Recombinant fully human anti-IL-17A monoclonal antibody injection (GR1501) 200 mg, subcutaneously administered, Q2W from week 0 to week 4
after week 4, administered Q4W until week 24.
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged = 18 years; 2. Meeting the 1977 American College of Rheumatology (ACR) and/or 2015 ACR and European League Against Rheumatism (EULAR) classification criteria for gouty arthritis [26, 27]; 3. Meeting the diagnostic criteria for refractory gout proposed in the "Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019)"; 4. Serum uric acid > 420 µmol/L; 5. Disease course exceeding 3 years; 6. Experiencing more than 2 acute gout flares per year; 7. Currently in the clinical course of an acute gout attack; 8. Patients receiving urate-lowering therapy (ULT) need to use a stable dose and schedule, without changing the treatment regimen during the first 4 weeks, and are expected to maintain a stable treatment regimen during participation in the study.
Exclusion criteria
Exclusion criteria: 1. Use of prohibited drugs before screening and administration (administration of >=10 mg prednisone or equivalent within 24 hours after screening; chronic corticosteroid therapy, defined as taking >=5 mg/day prednisone or equivalent for more than 28 days; intra-articular corticosteroid injection to the most affected joint within 14 days after screening; intramuscular corticosteroid injection within 14 days after screening; use of tramadol within 6 hours after screening; use of any IL-17 inhibitor, IL-1 inhibitor, tumor necrosis factor inhibitor, or other investigational biologics within 30 days or 5 half-lives; use of NSAIDs and/or colchicine within 24 hours after screening). 2. Hemodialysis within 1 month before screening. 3. Live vaccine immunization within 3 months before screening. 4. History of latent tuberculosis infection or tumors. 5. Acute or chronic active infection. 6. Presence of other types of arthritis such as rheumatoid arthritis, infectious arthritis, or other acute inflammatory arthritis. 7. Severe liver or kidney dysfunction, and severe heart, brain, or vascular lesions. 8. Pregnant or breastfeeding women. 9. Individuals with psychiatric disorders, history of alcoholism, immunodeficiency, or drug/other substance abuse. 10. Allergy to the components of this product. 11. Patients whom the investigator judges may be unable to comply with study requirements or are likely to withdraw themselves. 12. Contraindication, intolerance, or poor response to NSAIDs and/or colchicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean frequency of acute gout flares over 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in VAS scores at each visit (Day 1 and Weeks 2, 4, 8, 12, 16, 20, 24);Time to 50% reduction in VAS score at each visit (Weeks 2, 4);Proportion of patients with =1 flare at each visit (Weeks 2, 4, 8, 12, 16, 20, 24);Evaluation of the number and size of tophi at each visit (Weeks 24, 36, 48);Vital signs, clinical laboratory tests, and adverse events within 24 weeks.; | — |
Countries
China
Contacts
Public ContactQing Yufeng
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed