Gout
Conditions
Interventions
Group1:Initiation of low dose urate-lowering drugs
Group 2a:Initiation of low dose urate-lowering drugs
Group 2b:Initiation of standard dose urate-lowering drugs+ prevent gout flares drugs
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Part 1: Inclusion criteria for patients who have contraindications for preventive drugs 1. Aged between 18 and 75 years old, male or female; 2. Patients fulfilled 2015 ACR/EULAR Gout classification criteria; 3. Patients who have indications for uric acid lowering therapy; 4. Patients who have relative or absolute contraindications for NSAIDs, glucocorticoid, colchicine or other gout attack preventive drugssuch as: (1) drug allergy; (2) an active gastrointestinal ulcer/bleeding, or a history of recurrent ulcers/bleeding; (3) ischemic heart disease, or peripheral arterial disease and/or cerebrovascular disease; (4) severe renal function impairment (eGFR 9); (6) Other contraindications; 5. Volunteer and sign informed consent form; Part 2: Inclusion criteria for patients who have no contraindications for preventive drugs: 1. Aged between 18 and 75 years old, male or female; 2. Patients fulfilled 2015 ACR/EULAR Gout classification criteria; 3. Patients who have indications for uric acid lowering therapy; 4. Volunteer and sign informed consent form.
Exclusion criteria
Exclusion criteria: Part 1:Exclusion criteria for patients who have contraindications for preventive drugs 1. Patients at the stage of gout attack when enrolled; 2. Patients under urate-lowering therapy when enrolled; 3. Patients complicated with rheumatoid arthritis, infectious arthritis, pseudogout, or other inflammatory arthritis; 4. Women who are breast-feeding or pregnant, and those who plan to get pregnant, not willing to or haven't take sufficient contraceptive measures during the period of childbearing age; 5. Inability or unwillingness to offer informed consent or to comply with the trial requirements; 6. Other factors researchers consider not suitable for inclusion. Part 2: Exclusion criteria for patients who have no contraindications for preventive drugs 1. Patients at the stage of gout attack when enrolled; 2. Patients under urate-lowering therapy when enrolled; 3. Patients complicated with rheumatoid arthritis, infectious arthritis, pseudogout, or other inflammatory arthritis; 4. Patients who are allergic to the drugs under research; 5. Women who are breast-feeding or pregnant, and those who plan to get pregnant, not willing to or havent take sufficient contraceptive measures during the period of childbearing age; 6. Patients who have an active gastrointestinal ulcer/bleeding, or a history of recurrent ulcers/bleeding 7. Patients who have ischemic heart disease, or peripheral arterial disease and/or cerebrovascular disease. 8. Patients who have severe renal function impairment (eGFR 9); 10. Inability or unwillingness to offer informed consent or to comply with the trial requirements; 11. Other factors researchers consider not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gout attack;eGFR;Liver fuction;Blood routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood uric acid; | — |
Countries
China
Contacts
Public ContactZou Hejian
Huashan Hospital, Fudan University
Outcome results
None listed