Treatment of Refractory Gout With ACTH or Methylprednisolone

NCT04808856 | Unknown DMC

• 1 other identifier: ACTH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

• Measurement of pain

  Visual analogue scale (VAS 0-10)

  7 days

• Arthritis score

  Arthritis (redness and swelling fever 0-3) score

  7 days

Secondary Outcomes (1)

• Recurrence rate

  1 month

Study Arms (2)

ACTH

EXPERIMENTAL

Adrenocorticotropic Hormone

Drug: Adrenocorticotropic Hormone

Methylprednisolone

ACTIVE COMPARATOR

Methylprednisolone

Drug: Methylprednisolone Injection

Interventions

Adrenocorticotropic Hormone DRUG

Adrenocorticotropic Hormone Injection 25u qd iv \*3d

ACTH

Methylprednisolone Injection DRUG

Methylprednisolone Injection 40mg qd iv \*3d

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's hospital

Shanghai, Shanghai Municipality, 200070, China

RECRUITING

MeSH Terms

Conditions

Gout

Interventions

Adrenocorticotropic Hormone; Methylprednisolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shen Qu, M.D Ph.D

  Shanghai Tenth People' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hang Sun, MD

CONTACT

86-21-66301004; sunhang1027@126.com

Shen Qu, M.D Ph.D

CONTACT

86-21-66301004

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)