Treatment of Refractory Gout With ACTH or Methylprednisolone

Tongji University

Status: Unknown

Conditions: Gout

Treatments: Drug: Methylprednisolone Injection; Drug: Adrenocorticotropic Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT04808856

ACTH

Details and patient eligibility

About

To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.

Full 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 .

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ACTH

Experimental group

Description:

Adrenocorticotropic Hormone

Treatment:

Drug: Adrenocorticotropic Hormone

Methylprednisolone

Active Comparator group

Description:

Methylprednisolone

Treatment:

Drug: Methylprednisolone Injection