PsA (Psoriatic Arthritis)Phase 4NCT05988684
Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With PsA (CAMPA Study)
A Phase 4 study testing Metformin in people with PsA (Psoriatic Arthritis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PsA (Psoriatic Arthritis)
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Aug 2023to 30 Sep 2025
- Phase
- Phase 4
- 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
- fulfill the ClASsification criteria for Psoriatic ARthritis (CASPAR),
- are over 18 years old,
- have a Framingham Risk Score ≥ 10% (i.e. moderate to high CV risk) and
- have carotid plague on previous ultrasound.
Who cannot join
- have prior therapy with metformin during the last 6 months;
- have pre-existing diabetes as defined by the World Health Organization (WHO) criteria:
- fasting plasma glucose values of ≥ 7.0 mmol/L,
- 2-h post-load plasma glucose ≥ 11.1 mmol/L,
- HbA1c ≥ 6.5% or
- a random blood glucose ≥ 11.1 mmol/L);
Show all 16Show fewer
- have liver impairment: ALT more than or equal to 2.5×upper limits of normal;
- have renal impairment: serum creatinine levels more than or equal to 135µmol/L in males and more than or equal to 110µmol/L in females;
- have had ACS within the previous 3 months;
- have New York Heart Association functional class 3 or 4 heart failure;
- have uncontrolled angina;
- have 70% or more stenosis on initial CCTA;
- have clinically relevant current malignancy;
- are pregnant; breastfeeding or of childbearing potential but unwilling to use adequate contraception;
- are unable to give written informed consent;
- patients with moderate to heavy alcohol intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With Psoriatic Arthritis - a Pilot Randomized Controlled Trial
Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients.
Objective: To investigate the vascular effects of metformin in PsA patients without diabetes mellitus. The metabolic and anti-inflammatory roles of metformin will also be explored.
Read more
Study design: This is a 1-year, single-centered, pilot, open-labelled, randomized controlled trial. A total of 24 enrolled patients with PsA being followed at the Prince of Wales Hospital rheumatology clinics will be recruited and randomized to either metformin group or control group in a 1:1 ratio. Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events.
Expected outcomes: The data from this study will support that there will be significant difference in the proportion of subjects with carotid plaque progression between the metformin group and control group over a period of 1 year.
Read the detailed description
Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients.
All participants will be followed up at the Prince of Wales Hospital and receive tight-control treatment aiming at achieving minimal disease activity (MDA). It will be adjusted according to a standardized protocol based on the European League Against Rheumatism (EULAR) recommendation and the Hong Kong guideline on the use of biologics. Patients will be treated with methotrexate monotherapy and then other conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) or biologic DMARDs if they fail to achieve the pre-determined target. Assessment of efficacy will be performed every 3-6 months. If a patient does not achieve the desired treatment goal within 3-6 months of therapy, therapy will be stepped up, unless the patient declines or a toxic effect precludes this approach. Prednisolone at a dose ≤10mg/day will be allowed during the study period. Intra-articular steroid or local steroid injection to enthesitis and dactylitis are allowed during the study but will be forbidden in the 4 weeks before assessment. The details of the treatments received will be recorded.
Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events. Although the minimum effective dose for cardiovascular protection with metformin has not been determined, relatively low dose metformin has been shown to be effective for blood glucose control with reduced risk of gastrointestinal side-effects in the Asian population. Patients will be given the necessary number of metformin at each visit. At the following visits, surplus medication will be returned to the investigator. Compliance is calculated as a percentage, based on the number of tablets returned. Anti-hypertensive, anti-platelet and lipid-lowering medications can be initiated or titrated at the discretion of the treating physicians. The details of their usage will be documented.
The following clinical and laboratory variables will be assessed at each visit: erythrocyte sedimentation rate, C-reactive protein, bone profile, number of swollen joints (0-66), number of tender joints (0-68), visual analogue scale (VAS) for pain (0-100 mm, 100 mm=most pain), VAS for patient's global assessment (0-100 mm, 100 mm=worst score) and VAS for physician's global assessment (0-100 mm, 100 mm=worst score). The Maastricht Ankylosing Spondylitis Enthesitis Score, the Leeds Enthesitis Index, the Spondyloarthritis Research Consortium of Canada Enthesitis Index, number of digits with dactylitis, Bath ankylosing spondylitis disease activity index (for patients with axial involvement), body surface area and Psoriasis Activity and Severity Index are used to measure joint and skin disease activity, and will be recorded every visit. The number of damaged joints will be assessed yearly. Functional disability is assessed by the Health Assessment Questionnaire (HAQ) Disability Index (0-3=most functional disability) every visit.
Minimal disease activity (MDA) will be employed as the treatment target of PsA. The MDA criteria assess 7 domains, with the following cutoffs: tender joint count ≤1, swollen joint count ≤1, enthesitis count ≤1, skin score ≤1 (or body surface area ≤3%), function score ≤0.5 (measured by the HAQ), patient's global assessment ≤20 on a 100-mm VAS, and patient-reported pain ≤15 on a 100-mm VAS. If 5 of the 7 cutoffs for these domains are met, then the patient is classified as having MDA. Achieving MDA results in significant benefits in articular disease and can distinguish clearly active treatment from placebo. The investigators have previously shown that achieving sustained MDA, which is believed to be more stringent, but not other composite target, was associated with a protective effect in subclinical atherosclerosis and arterial stiffness progression.
- Conditions
- PsA (Psoriatic Arthritis)
- Being tested
- Metformin
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Patients randomized to metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin group will be instructed to take metformin Receives: Drug: Metformin |
| control | No intervention | Standard treatment and Follow-up, no metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of subjects with carotid plaque progression between the metformin group and control group
Carotid plaques will be assessed at baseline and 12 months using a high-resolution B mode ultrasound machine (Philips EPIQ7) by a single experienced sonographer blinded to all clinical information using a 30-MHz linear vascular probe (Philips L12-3 broadband linear array transducer). Plaque progression is defined as an incident plaque in a segment without plaque before or an increase in number of plaque.
The primary outcome will be analyzed using multivariate logistic regression model. In univariate analysis, potential covariates including age, sex, traditional cardiovascular risk factor, disease activity and use of statin or biologic or targeted synthetic disease modifying anti-rheumatic drugs would be included. Variables which are significantly different between the two groups in the univariate analyses and are biologically plausible will be adjusted in the multivariate logistic regression model to confirm the metformin treatment effect.
Measured: 1 year
Secondary outcomes (11)
Changes in mean carotid intima-media thickness (CIMT) between the two groups
The CIMT will be measured offline in the distal common carotid artery, bulb, and proximal internal carotid artery using dedicated software (Philips Xcelera Cardiology Enterprise Viewer Client 4). The mean and maximal IMT values of 6 arterial segments will be calculated for further analysis.
The secondary outcomes on other carotid and coronary atherosclerosis parameters, multivariate linear regression or logistic regression model similar to the primary outcome analysis would be used with adjustment for covariates.
Measured: 1 year
Changes in carotid total plaque area (TPA) between the two groups
For TPA, the plane for measurement of each plaque will be chosen by reviewing the video of the scan to find the largest extent of plaque as seen on the longitudinal view. TPA will be recorded as the sum of the areas of all plaques in the right and left carotid arteries. Reading of the ultrasound scans obtained at baseline and follow-up will be performed concurrently by a single reader who is aware of the temporal order of the images but is blinded to all clinical data.
The secondary outcomes on other carotid and coronary atherosclerosis parameters, multivariate linear regression or logistic regression model similar to the primary outcome analysis would be used with adjustment for covariates.
Measured: 1 year
Changes in coronary artery calcification (CAC) score
Coronary computer tomography angiogram (CCTA) scans will be performed at baseline and 12 months with 256-rows dual source multi-detector CT (Siemens Somatom Drive). CAC will be quantified by the Agatston method (normal = 0, higher = worse score). The images will be analyzed by an experienced radiologist blinded to all clinical data.
The secondary outcomes on other carotid and coronary atherosclerosis parameters, multivariate linear regression or logistic regression model similar to the primary outcome analysis would be used with adjustment for covariates.
Measured: 1 year
Changes in coronary plaque volume
CCTA scans will be performed at baseline and 12 months with 256-rows dual source multi-detector computer tomography (CT) (Siemens Somatom Drive). Coronary arteries will be standardized to the American Heart Association 15-segment model. Non-calcified plaque volumes will be measured (CardIQ Xpress 2.0 Reveal, General Electic). The images will be analyzed by an experienced radiologist blinded to all clinical data.
The secondary outcomes on other carotid and coronary atherosclerosis parameters, multivariate linear regression or logistic regression model similar to the primary outcome analysis would be used with adjustment for covariates.
Measured: 1 year
Changes in coronary stenosis level
CCTA scans will be performed at baseline and 12 months with 256-rows dual source multi-detector computer tomography (CT) (Siemens Somatom Drive). Coronary arteries will be standardized to the American Heart Association 15-segment model. Lesions rendering over 50% stenosis of the lumen will be considered as obstructive. For multiple plaques, the most stenotic one will be recorded. The images will be analyzed by an experienced radiologist blinded to all clinical data.
The secondary outcomes on other carotid and coronary atherosclerosis parameters, multivariate linear regression or logistic regression model similar to the primary outcome analysis would be used with adjustment for covariates.
Measured: 1 year
Changes in anthropometric measurements
The patients' body mass index (BMI) will be checked at baseline and after 1 year.
Mann-Whitney U test will be used to evaluate the differences between the metformin and the placebo group at baseline as well as after 1 year.
Measured: 1 year
Changes in sugar levels
The patients' fasting blood glucose will be checked at baseline and after 1 year.
Mann-Whitney U test will be used to evaluate the differences between the metformin and the placebo group at baseline as well as after 1 year.
Measured: 1 year
Changes in insulin resistance
The patients' Hba1c will be checked at baseline and after 1 year.
Mann-Whitney U test will be used to evaluate the differences between the metformin and the placebo group at baseline as well as after 1 year.
Measured: 1 year
Changes in cholesterol level in terms of cholesterol ratio (total cholesterol/high density lipoprotein)
The patients' lipid profile will be checked at baseline and after 1 year.
Mann-Whitney U test will be used to evaluate the differences between the metformin and the placebo group at baseline as well as after 1 year.
Measured: 1 year
Occurrence of adverse events
All adverse events will be reported and recorded.
Occurrence of adverse effects will be compared by Chi-square test or fisher exact test.
Measured: 1 year
PsA disease activity control in terms of minimal disease activity (MDA) achievement
The MDA criteria assess 7 domains: number of tender joints (0-68), number of swollen joints (0-66), visual analogue scale (VAS) for pain (0-100 mm, 100 mm=most pain), VAS for patient's global assessment (0-100 mm, 100 mm=worst score), tender entheseal point and Psoriasis Area and Severity Index(PASI)/body surface area(BSA). Functional disability is assessed by the Health Assessment Questionnaire (HAQ) (0-3=most functional disability). The MDA criteria have the following cutoffs: tender joint count ≤1, swollen joint count ≤1, enthesitis count ≤1, PASI ≤1 (or BSA ≤3%), function score ≤0.5 (measured by the HAQ), patient's global assessment ≤20 and patient-reported pain ≤15 on a 100-mm VAS. If 5 of the 7 cutoffs for these domains are met, then the patient is classified as having MDA.
Chi-square test or fisher exact test will be used to evaluate the differences in proportion of patients with MDA between the metformin and the placebo group at 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Aug 2023
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsA (Psoriatic Arthritis)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho SO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988684
- Sponsor's protocol ID
- CAMPA
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized clinical data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With Psoriatic Arthritis - a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05988684
- Acronym / sponsor ID
- CAMPA
- Conditions
- PsA (Psoriatic Arthritis)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Aug 2023 (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.
Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients.
Objective: To investigate the vascular effects of metformin in PsA patients without diabetes mellitus. The metabolic and anti-inflammatory roles of metformin will also be explored.
Study design: This is a 1-year, single-centered, pilot, open-labelled, randomized controlled trial. A total of 24 enrolled patients with PsA being followed at the Prince of Wales Hospital rheumatology clinics will be recruited and randomized to either metformin group or control group in a 1:1 ratio. Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events.
Expected outcomes: The data from this study will support that there will be significant difference in the proportion of subjects with carotid plaque progression between the metformin group and control group over a period of 1 year.
Detailed description
Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients.
All participants will be followed up at the Prince of Wales Hospital and receive tight-control treatment aiming at achieving minimal disease activity (MDA). It will be adjusted according to a standardized protocol based on the European League Against Rheumatism (EULAR) recommendation and the Hong Kong guideline on the use of biologics. Patients will be treated with methotrexate monotherapy and then other conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) or biologic DMARDs if they fail to achieve the pre-determined target. Assessment of efficacy will be performed every 3-6 months. If a patient does not achieve the desired treatment goal within 3-6 months of therapy, therapy will be stepped up, unless the patient declines or a toxic effect precludes this approach. Prednisolone at a dose ≤10mg/day will be allowed during the study period. Intra-articular steroid or local steroid injection to enthesitis and dactylitis are allowed during the study but will be forbidden in the 4 weeks before assessment. The details of the treatments received will be recorded.
Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events. Although the minimum effective dose for cardiovascular protection with metformin has not been determined, relatively low dose metformin has been shown to be effective for blood glucose control with reduced risk of gastrointestinal side-effects in the Asian population. Patients will be given the necessary number of metformin at each visit. At the following visits, surplus medication will be returned to the investigator. Compliance is calculated as a percentage, based on the number of tablets returned. Anti-hypertensive, anti-platelet and lipid-lowering medications can be initiated or titrated at the discretion of the treating physicians. The details of their usage will be documented.
The following clinical and laboratory variables will be assessed at each visit: erythrocyte sedimentation rate, C-reactive protein, bone profile, number of swollen joints (0-66), number of tender joints (0-68), visual analogue scale (VAS) for pain (0-100 mm, 100 mm=most pain), VAS for patient's global assessment (0-100 mm, 100 mm=worst score) and VAS for physician's global assessment (0-100 mm, 100 mm=worst score). The Maastricht Ankylosing Spondylitis Enthesitis Score, the Leeds Enthesitis Index, the Spondyloarthritis Research Consortium of Canada Enthesitis Index, number of digits with dactylitis, Bath ankylosing spondylitis disease activity index (for patients with axial involvement), body surface area and Psoriasis Activity and Severity Index are used to measure joint and skin disease activity, and will be recorded every visit. The number of damaged joints will be assessed yearly. Functional disability is assessed by the Health Assessment Questionnaire (HAQ) Disability Index (0-3=most functional disability) every visit.
Minimal disease activity (MDA) will be employed as the treatment target of PsA. The MDA criteria assess 7 domains, with the following cutoffs: tender joint count ≤1, swollen joint count ≤1, enthesitis count ≤1, skin score ≤1 (or body surface area ≤3%), function score ≤0.5 (measured by the HAQ), patient's global assessment ≤20 on a 100-mm VAS, and patient-reported pain ≤15 on a 100-mm VAS. If 5 of the 7 cutoffs for these domains are met, then the patient is classified as having MDA. Achieving MDA results in significant benefits in articular disease and can distinguish clearly active treatment from placebo. The investigators have previously shown that achieving sustained MDA, which is believed to be more stringent, but not other composite target, was associated with a protective effect in subclinical atherosclerosis and arterial stiffness progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin group will be instructed to take metformin |
| control | No intervention | –Standard treatment and Follow-up, no metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fulfill the ClASsification criteria for Psoriatic ARthritis (CASPAR),
- are over 18 years old,
- have a Framingham Risk Score ≥ 10% (i.e. moderate to high CV risk) and
- have carotid plague on previous ultrasound.
Key exclusion criteria (16 listed)
- have prior therapy with metformin during the last 6 months;
- have pre-existing diabetes as defined by the World Health Organization (WHO) criteria:
- have liver impairment: ALT more than or equal to 2.5×upper limits of normal;
- have renal impairment: serum creatinine levels more than or equal to 135µmol/L in males and more than or equal to 110µmol/L in females;
- have had ACS within the previous 3 months;
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 |
|---|---|---|
| MetforminAlso: GlucophagePatients randomized to metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day | Drug | Metformin |
Primary outcome
Difference in the proportion of subjects with carotid plaque progression between the metformin group and control group
Time frame: 1 year
Carotid plaques will be assessed at baseline and 12 months using a high-resolution B mode ultrasound machine (Philips EPIQ7) by a single experienced sonographer blinded to all clinical information using a 30-MHz linear vascular probe (Philips L12-3 broadband linear array transducer). Plaque progression is defined as an incident plaque in a segment without plaque before or an increase in number of plaque. The primary outcome will be analyzed using multivariate logistic regression model. In univariate analysis, potential covariates including age, sex, traditional cardiovascular risk factor, disease activity and use of statin or biologic or targeted synthetic disease modifying anti-rheumatic drugs would be included. Variables which are significantly different between the two groups in the univariate analyses and are biologically plausible will be adjusted in the multivariate logistic regression model to confirm the metformin treatment effect.
11 secondary outcomes
Changes in mean carotid intima-media thickness (CIMT) between the two groups
Time frame: 1 year
Changes in carotid total plaque area (TPA) between the two groups
Time frame: 1 year
Changes in coronary artery calcification (CAC) score
Time frame: 1 year
Changes in coronary plaque volume
Time frame: 1 year
Changes in coronary stenosis level
Time frame: 1 year
Changes in anthropometric measurements
Time frame: 1 year
Changes in sugar levels
Time frame: 1 year
Changes in insulin resistance
Time frame: 1 year
Changes in cholesterol level in terms of cholesterol ratio (total cholesterol/high density lipoprotein)
Time frame: 1 year
Occurrence of adverse events
Time frame: 1 year
PsA disease activity control in terms of minimal disease activity (MDA) achievement
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. Anonymized clinical data can be shared upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with PsA (Psoriatic Arthritis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 24 Nov 2025. 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 Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of subjects with carotid plaque progression between the metformin group and control group (time frame: 1 year). 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 24 Nov 2025.