Gout
Conditions
Brief summary
To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.
Detailed description
When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .
Interventions
Adrenocorticotropic Hormone Injection 25u qd iv \*3d
Methylprednisolone Injection 40mg qd iv \*3d
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (123 items and 1 item from 4-7 are met simultaneously) : 1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout 2. Acute gouty arthritis 3. Age ≥18 4. Repeated attacks and prolonged pain (more than 1 month); 5. poor response or intolerance to colchicine or NSAIDs; 6. Liver and kidney dysfunction; 7. Old age;
Exclusion criteria
* 1\) History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of pain | 7 days | Visual analogue scale (VAS 0-10) |
| Arthritis score | 7 days | Arthritis (redness and swelling fever 0-3) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 1 month | Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence) |
Countries
China
Contacts
Primary ContactHang Sun, MD
Backup ContactShen Qu, M.D Ph.D
Outcome results
None listed