chronic tophi arthritis
Conditions
Interventions
experimental group:Baricitinib 2mg/day with basic therapy
control group:Placebo with basic therapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years (including the threshold value), no gender limit; 2. Meet the 2015 gout classification criteria of the American College of Rheumatology (ACR); 3. The subject is currently in the stage of chronic gout; 4. The subject has no acute attack of gout within 7 days prior to the use of the experimental drug (as determined by the investigator based on the subject's symptoms and signs, referral records, etc.); 5. Serum uric acid <=300umol/L during the screening period and baseline period, and can continue to use the current uric acid lowering regimen throughout the study period; 6. Male subjects and their partners or female subjects must agree to use one or more non-drug contraceptive methods (such as total abstinence, contraceptive rings, partner ligation) for 4 months after the use of the test drug and to refrain from fertility, sperm and egg donation plans for 4 months after the use of the test drug; 7. Voluntarily participate in this experiment and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of IL-1 blockers, TNF-a inhibitors, other biologics or investigational drugs within 30 days prior to screening or within 5 half-lives, whichever is older; 2. The patient suspected or diagnosed with active tuberculosis by chest imaging examination; 3. Ongoing, chronic or recurrent bacterial, fungal, or viral infections (including those with a previous history of HIV infection or hepatitis C) that were known or suspected to require drug intervention at the time of inclusion, except those who received antiviral therapy for hepatitis B and were currently HBV-DNA negative (they must also receive anti-hepatitis B drug therapy during the study period); 4. Patients with a history of cancer within 5 years before screening; 5. The laboratory examination indexes in the screening period do not meet the requirements of the program; 6. There are significant diseases, including but not limited to: Poorly controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100mmHg), congestive heart failure (NYHA grade III and above), poorly controlled type I and type II diabetes (HBA1c >8.5%) were selected based on the subject's condition; 7. Myocardial infarction, angina pectoris, percutaneous intra-coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within 3 months before screening; 8. Patients had received live attenuated vaccine within 3 months prior to screening or planned to receive live or attenuated vaccine during the study period; 9. Blood donation or blood loss of more than 400ml within 8 weeks before screening; 10. Secondary gout (such as gout caused by chemotherapy, transplantable gout); 11. Evidence or suspicion of infectious/septic arthritis; 12. History of allergic reaction to test supplies and auxiliary materials; 13. Patients participating in clinical trials of other drugs or devices; 14. Pregnant or lactating female patients; 15. Other conditions assessed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gouty radiology bone erosion (target joint);Incidence of adverse events (AE)/serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte sedimentation rate, ESR;C-reactive protein;Serum amyloid A;Interleukin-1ß;Tumor necrosis factor-a;Interleukin-6; | — |
Countries
China
Contacts
Public ContactXue Yu/Yu Yiyun
Huashan Hospital, Fudan University
Outcome results
None listed