Treatment of Refractory Gout With ACTH or Methylprednisolone

Not Applicable

• Conditions: Gout
• Interventions: Drug: Methylprednisolone Injection; Drug: Adrenocorticotropic Hormone

• Registration Number: NCT04808856
• Lead Sponsor: Shanghai 10th People's Hospital

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 .

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-19
• Last Update Submitted: 2021-03-19
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-22
• Study Start: 2021-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone	Methylprednisolone Injection	Methylprednisolone
ACTH	Adrenocorticotropic Hormone	Adrenocorticotropic Hormone

Primary Outcome Measures

Name	Time	Method
Arthritis score	7 days	Arthritis (redness and swelling fever 0-3) score
Measurement of pain	7 days	Visual analogue scale (VAS 0-10)

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	1 month	Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)

Trial Locations

Locations (1)

Shanghai Tenth People's hospital; 🇨🇳 Shanghai, Shanghai, China