Treatment of Refractory Gout With ACTH or Methylprednisolone

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04808856

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: Adrenocorticotropic Hormone Drug: Methylprednisolone Injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACTH Adrenocorticotropic Hormone	Drug: Adrenocorticotropic Hormone Adrenocorticotropic Hormone Injection 25u qd iv *3d
Active Comparator: Methylprednisolone Methylprednisolone	Drug: Methylprednisolone Injection Methylprednisolone Injection 40mg qd iv *3d

Arm

Intervention/Treatment

Experimental: ACTH

Adrenocorticotropic Hormone

Drug: Adrenocorticotropic Hormone

Adrenocorticotropic Hormone Injection 25u qd iv *3d

Active Comparator: Methylprednisolone

Methylprednisolone

Drug: Methylprednisolone Injection

Methylprednisolone Injection 40mg qd iv *3d

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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