Treatment of Refractory Gout With ACTH or Methylprednisolone

Gout Clinical Trial

Official title:

Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808856
• Other study ID #: ACTH
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2021
• Source: Shanghai 10th People's Hospital
• Contact: Hang Sun, MD
• Phone: 86-21-66301004
• Email: sunhang1027[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Adrenocorticotropic Hormone
Adrenocorticotropic Hormone Injection 25u qd iv *3d
• Methylprednisolone Injection
Methylprednisolone Injection 40mg qd iv *3d

Locations

Country	Name	City	State
China	Shanghai Tenth People's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pain	Visual analogue scale (VAS 0-10)	7 days
Primary	Arthritis score	Arthritis (redness and swelling fever 0-3) score	7 days
Secondary	Recurrence rate	Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)	1 month