Treatment of Refractory Gout With ACTH or Methylprednisolone

Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone

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

Study Overview

• Status: Unknown
• Conditions: Gout
• Intervention / Treatment: Drug: Adrenocorticotropic Hormone; Drug: Methylprednisolone Injection

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hang Sun, MD; Phone Number: 86-21-66301004; Email: sunhang1027@126.com
• Study Contact Backup: Name: Shen Qu, M.D Ph.D; Phone Number: 86-21-66301004

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Hang Sun, MD; Phone Number: 86-21-66301004; Email: sunhang1027@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of pain	Visual analogue scale (VAS 0-10)	7 days
Arthritis score	Arthritis (redness and swelling fever 0-3) score	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)	1 month

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Shen Qu, M.D Ph.D, Shanghai Tenth People' Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Methylprednisolone; Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: ACTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No