GoutNCT04808856
Treatment of Refractory Gout With ACTH or Methylprednisolone
A study testing Adrenocorticotropic Hormone and Methylprednisolone Injection in people with Gout, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Adrenocorticotropic Hormone and Methylprednisolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Shen Qu, M.D Ph.D contact
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's hospital
Shanghai, Shanghai Municipality, 200070
Hang Sun, MD, 86-21-66301004, sunhang1027@126.com
About this study
Official title: 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.
Read the 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 .
- Conditions
- Gout
- Being tested
- Adrenocorticotropic Hormone, Methylprednisolone Injection
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenocorticotropic HormoneDrug
Adrenocorticotropic Hormone Injection 25u qd iv *3d
Methylprednisolone InjectionDrug
Methylprednisolone Injection 40mg qd iv *3d
| Study group | Role | What they receive |
|---|---|---|
| ACTH | Experimental | Adrenocorticotropic Hormone Receives: Drug: Adrenocorticotropic Hormone |
| Methylprednisolone | Active comparator | Methylprednisolone Receives: Drug: Methylprednisolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain
Visual analogue scale (VAS 0-10)
Measured: 7 days
Arthritis score
Arthritis (redness and swelling fever 0-3) score
Measured: 7 days
Secondary outcomes (1)
Recurrence rate
Recurrence rate (3d, 7d, 2w, 1m follow-up; recurrence within 1m was defined as recurrence)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Shen Qu, M.D Ph.D, Principal investigator, Shanghai Tenth People' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808856
- Sponsor's protocol ID
- ACTH
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone
- ClinicalTrials.gov ID
- NCT04808856
- Acronym / sponsor ID
- ACTH
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTH | Experimental | Drug: Adrenocorticotropic HormoneAdrenocorticotropic Hormone |
| Methylprednisolone | Active comparator | Drug: Methylprednisolone InjectionMethylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (123 items and 1 item from 4-7 are met simultaneously) :
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenocorticotropic HormoneAdrenocorticotropic Hormone Injection 25u qd iv *3d | Drug | ACTH |
| Methylprednisolone InjectionMethylprednisolone Injection 40mg qd iv *3d | Drug | Methylprednisolone |
Primary outcome
Measurement of pain
Time frame: 7 days
Visual analogue scale (VAS 0-10)
Arthritis score
Time frame: 7 days
Arthritis (redness and swelling fever 0-3) score
1 secondary outcome
Recurrence rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Qu, M.D Ph.D contact
Shen Qu, M.D Ph.D principal investigator
Shanghai Tenth People' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenocorticotropic Hormone and Methylprednisolone Injection in people with Gout, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hang Sun, MD (86-21-66301004, sunhang1027@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pain (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.