Treatment of Refractory Gout With ACTH or Methylprednisolone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-01

Brief Summary

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

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Detailed Description

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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 .

Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACTH

Adrenocorticotropic Hormone

Group Type EXPERIMENTAL

Adrenocorticotropic Hormone

Intervention Type DRUG

Adrenocorticotropic Hormone Injection 25u qd iv \*3d

Methylprednisolone

Group Type ACTIVE_COMPARATOR

Methylprednisolone Injection

Intervention Type DRUG

Methylprednisolone Injection 40mg qd iv \*3d

Interventions

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Adrenocorticotropic Hormone

Adrenocorticotropic Hormone Injection 25u qd iv \*3d

Intervention Type DRUG

Methylprednisolone Injection

Methylprednisolone Injection 40mg qd iv \*3d

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No