NCT05988684CompletedPhase 4

Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With PsA (CAMPA Study)

Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With Psoriatic Arthritis - a Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 24 (actual)
First submitted: 12 Jul 2023
Start date: 30 Aug 2023
Primary completion date: 31 Aug 2025
Lead sponsor: Chinese University of Hong Kong
Diseases: Psoriasis, Psoriatic arthritis
NCT number: NCT05988684

What you commit to

Study type: Interventional · Phase 4
Participants enrolled: 24
From 30 Aug 2023 to the primary completion date, 31 Aug 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

have prior therapy with metformin during the last 6 months;
have had ACS within the previous 3 months;

Other illness

have New York Heart Association functional class 3 or 4 heart failure;
have uncontrolled angina;
have clinically relevant current malignancy;

Lab values

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);
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;

Other

have 70% or more stenosis on initial CCTA;
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.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The Chinese University of Hong Kong Coordinator of this site? Confirm its status	Hong Kong	Hong Kong SAR China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.