Treatment of Refractory Gout With ACTH or Methylprednisolone

Study Overview
=================
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 .

Official Title
-----------------
Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: Adrenocorticotropic Hormone
* Drug: Methylprednisolone Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (123 items and 1 item from 4-7 are met simultaneously) : Meet the 2015 ACR/EULAR classification diagnostic criteria for gout Acute gouty arthritis Age ≥18 Repeated attacks and prolonged pain (more than 1 month); poor response or intolerance to colchicine or NSAIDs; Liver and kidney dysfunction; 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTH<br>Adrenocorticotropic Hormone | Drug: Adrenocorticotropic Hormone<br>* Adrenocorticotropic Hormone Injection 25u qd iv *3d<br>|
| Active Comparator: Methylprednisolone<br>Methylprednisolone | Drug: Methylprednisolone Injection<br>* Methylprednisolone Injection 40mg qd iv *3d<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pain | Visual analogue scale (VAS 0-10) | 7 days | 
| Arthritis score | Arthritis (redness and swelling fever 0-3) score | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence) | 1 month |