Back to resultsTreatment of Refractory Gout With ACTH or Methylprednisolone
Primary Purpose
Gout
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Adrenocorticotropic Hormone
Methylprednisolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
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
Sites / Locations
- Shanghai Tenth People's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACTH
Methylprednisolone
Arm Description
Adrenocorticotropic Hormone
Methylprednisolone
Outcomes
Primary Outcome Measures
Measurement of pain
Visual analogue scale (VAS 0-10)
Arthritis score
Arthritis (redness and swelling fever 0-3) score
Secondary Outcome Measures
Recurrence rate
Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)
Full Information
NCT ID
NCT04808856
First Posted
March 16, 2021
Last Updated
March 19, 2021
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04808856
Brief Title
Treatment of Refractory Gout With ACTH or Methylprednisolone
Official Title
Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTH
Arm Type
Experimental
Arm Description
Adrenocorticotropic Hormone
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Adrenocorticotropic Hormone
Intervention Description
Adrenocorticotropic Hormone Injection 25u qd iv *3d
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Intervention Description
Methylprednisolone Injection 40mg qd iv *3d
Primary Outcome Measure Information:
Title
Measurement of pain
Description
Visual analogue scale (VAS 0-10)
Time Frame
7 days
Title
Arthritis score
Description
Arthritis (redness and swelling fever 0-3) score
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Sun, MD
Phone
86-21-66301004
Email
sunhang1027@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Qu, M.D Ph.D
Phone
86-21-66301004
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, M.D Ph.D
Organizational Affiliation
Shanghai Tenth People' Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang Sun, MD
Phone
86-21-66301004
Email
sunhang1027@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Refractory Gout With ACTH or Methylprednisolone
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