Psoriatic ArthritisNCT02232321
Vascular Effects of Achieving Minimal Disease Activity in Psoriatic Arthritis - a 2 Year Prospective Cohort Study
A study testing PsA MDA in people with Psoriatic Arthritis and Atherosclerosis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Objectives To investigate the effect of achieving minimal disease activity (MDA) using a protocolized treatment strategy on the progression of subclinical atherosclerosis and arterial stiffness in psoriatic arthritis (PsA) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriatic Arthritis, Atherosclerosis, Arterial Stiffness
- What is being tested?
- PsA MDA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PsA attending the outpatient clinic of the Prince of Wales Hospital (PWH) who fulfilled the Classification of Psoriatic Arthritis criteria
Who cannot join
- 1) have a history of overt CVD (myocardial infarction, percutaneous transluminal coronary angioplasty, surgery for ischemic heart disease, stroke, transient ischemic attack, carotid endarterectomy, peripheral arterial reconstructive surgery, or limb amputation), or 2) are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI), or 3) have significant co-morbidities including severe renal impairment defined as a glomerular filtration rate of less than 30 mL/min/1.73m2, alanine aminotransferase (ALT) ≥2xULN, hemoglobin level <8.5gm/dl, white blood cell count <3.5x109/liter, platelet count<100x109/liter, or 4) female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women, or 5) they are on glucocorticoids at a dose >10mg/day (equivalent dose of prednisolone)
Trial locations and contacts
1 site in 1 country.
About this study
Objectives To investigate the effect of achieving minimal disease activity (MDA) using a protocolized treatment strategy on the progression of subclinical atherosclerosis and arterial stiffness in psoriatic arthritis (PsA) patients.
Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have less progression of subclinical atherosclerosis and arterial stiffness then patients who cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA.
Read more
Design and subjects One hundred consecutive PsA patients will participate in this 2-year prospective, hospital-based, cohort study.
Interventions All participants will receive 2-year tight-control treatment. Treatment 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 every 4-monthly aiming at MDA.
Study instruments Carotid intima-media thickness (IMT) will be measured using high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV) by a dedicated tonometry system and augmentation index (AIx) by the SphygmoCor device.
Main outcome measures and analysis The main outcome measure is the change in IMT over a period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT, AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.
Read the detailed description
Background:
Patients with psoriatic arthritis (PsA) experience substantial morbidity and unfavorable outcomes at referral centers. Although studies on all-cause mortality have yielded mixed results, increased cardiovascular (CV) mortality and morbidity in PsA have been consistently reported. Data from our group and others have shown that underlying these higher CV disease (CVD) rates is a greater burden of subclinical carotid atherosclerosis. Increased intima-media thickness (IMT) significantly correlates with traditional risk factors and disease-related parameters. An increased prevalence of arterial stiffness has also been demonstrated in patients with psoriasis and PsA compared with controls. In PsA, criteria for minimal disease activity (MDA) have been developed and validated. These criteria use 7 measurements including entheseal and skin assessments. Achieving MDA by these criteria results in less radiographic damage in the long term. The development of this instrument is a step toward 'treatment to target' in PsA. MDA is achieved in 48-60% of patients at ≥ 1 visit, and is sustained for ≥ 12 months (sustained MDA) in at least one third of PsA patients in a large observational cohort.
While achieving MDA may result in significant benefits in articular disease, little is known about its effect on extra-articular disease, including CVD risk. The use of surrogate end points instead of actual CV events may provide more evidence on whether PsA patients may benefit from potent anti-inflammatory treatment on the prevention of premature atherosclerosis. Data from our group and others linked the suppression of inflammation using anti-tumour necrosis factor (anti-TNF) with a favourable effect on CV surrogate makers, including carotid IMT and arterial stiffness. More recently, a tight-control treatment strategy aiming at remission was effective in improving arterial stiffness in our early rheumatoid arthritis (RA) cohort. There is an imperative need for interventional trials with CV end points to investigate whether achievement of MDA by a protocolized treatment strategy could reduce CVD risk in PsA. To fill in these gaps of knowledge, we propose a prospective cohort study to ascertain whether achieving MDA through a protocolized treatment strategy may prevent long term progression of IMT and arterial stiffness to a greater extent than those who cannot achieve MDA in patients with PsA.
Aim of the study:
Primary outcome:
- Effect of achieving MDA (MDA group) at 12 months on the progression of subclinical atherosclerosis over a period of 24 months as evaluated by IMT compared to those who cannot achieve MDA (non-MDA group)
Secondary outcomes:
- Changes in arterial stiffness over a period of 24 months as evaluated by pulse wave velocity (PWV) and augmentation Index (AIx) between the MDA group and non-MDA group.
- The proportion of patients achieving sustained MDA (from 12 to 24 months)
- Changes in IMT and arterial stiffness over a period of 24 months as evaluated by IMT, PWV and AIx between patients who can achieve sustained MDA and those who cannot achieve sustained MDA.
- Correlations between the changes in IMT, PWV, and AIX and the changes in markers of disease activity
Hypothesis:
Effective suppression of inflammation in PsA patients who can achieve MDA will have less progression of subclinical atherosclerosis and arterial stiffness than patients who cannot achieve MDA by means of a protocolized treatment algorithm
- Conditions
- Psoriatic Arthritis, Atherosclerosis, Arterial Stiffness
- Being tested
- PsA MDA
- Medical subject headings
- Arthritis, Psoriatic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsA MDAOther
| Study group | Role | What they receive |
|---|---|---|
| PsA MDA | Other | Not described Receives: Other: PsA MDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
PsA MDA and subclinical atherosclerosis
Effect of achieving MDA (MDA group) at 12 months on the progression of subclinical atherosclerosis over a period of 24 months as evaluated by IMT compared to those who cannot achieve MDA (non-MDA group).
Measured: 30 months
Secondary outcomes (4)
PsA MDA and arterial stiffness
Changes in arterial stiffness over a period of 24 months as evaluated by pulse wave velocity (PWV) and augmentation Index (AIx) between the MDA group and non-MDA group.
Measured: 30 months
PsA MDA rate
The proportion of patients achieving sustained MDA (from 12 to 24 months)
Measured: 30 months
PsA sustained MDA and atherosclerosis and arterial stiffness
Changes in IMT and arterial stiffness over a period of 24 months as evaluated by IMT, PWV and AIx between patients who can achieve sustained MDA and those who cannot achieve sustained MDA.
Measured: 30 month
PsA atherosclerosis and arterial stiffness
Correlations between the changes in IMT, PWV, and AIX and the changes in markers of disease activity
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232321
- Sponsor's protocol ID
- PsA-MDA
- Status last verified
- Jul 2018
- First submitted
- 2 Sep 2014
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng IT, Shang Q, Li EK, Wong PC, Kun EW, Law MY, Yip RM, Yim IC, Lai BT, Ying SK, Kwok KY, Li M, Li TK, Zhu TY, Lee JJ, Chang MM, Szeto CC, Yan BP, Lee AP, Tam LS. Effect of Achieving Minimal Disease Activity on the Progression of Subclinical Atherosclerosis and Arterial Stiffness: A Prospective Cohort Study in Psoriatic Arthritis. Arthritis Rheumatol. 2019 Feb;71(2):271-280. doi: 10.1002/art.40695. Epub 2019 Jan 5.
PubMed 30144299Shen J, Wong KT, Cheng IT, Shang Q, Li EK, Wong P, Kun EW, Law MY, Yip R, Yim I, Ying S, Li M, Li TK, Wong CK, Zhu TY, Lee JJ, Chang M, Lee AP, Tam LS. Increased prevalence of coronary plaque in patients with psoriatic arthritis without prior diagnosis of coronary artery disease. Ann Rheum Dis. 2017 Jul;76(7):1237-1244. doi: 10.1136/annrheumdis-2016-210390. Epub 2017 Jan 4.
PubMed 28052860
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effects of Achieving Minimal Disease Activity in Psoriatic Arthritis - a 2 Year Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02232321
- Acronym / sponsor ID
- PsA-MDA
- Conditions
- Psoriatic Arthritis, Atherosclerosis, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 Sep 2014 (estimated)
- 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.
Objectives To investigate the effect of achieving minimal disease activity (MDA) using a protocolized treatment strategy on the progression of subclinical atherosclerosis and arterial stiffness in psoriatic arthritis (PsA) patients.
Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have less progression of subclinical atherosclerosis and arterial stiffness then patients who cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA.
Design and subjects One hundred consecutive PsA patients will participate in this 2-year prospective, hospital-based, cohort study.
Interventions All participants will receive 2-year tight-control treatment. Treatment 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 every 4-monthly aiming at MDA.
Study instruments Carotid intima-media thickness (IMT) will be measured using high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV) by a dedicated tonometry system and augmentation index (AIx) by the SphygmoCor device.
Main outcome measures and analysis The main outcome measure is the change in IMT over a period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT, AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.
Detailed description
Background:
Patients with psoriatic arthritis (PsA) experience substantial morbidity and unfavorable outcomes at referral centers. Although studies on all-cause mortality have yielded mixed results, increased cardiovascular (CV) mortality and morbidity in PsA have been consistently reported. Data from our group and others have shown that underlying these higher CV disease (CVD) rates is a greater burden of subclinical carotid atherosclerosis. Increased intima-media thickness (IMT) significantly correlates with traditional risk factors and disease-related parameters. An increased prevalence of arterial stiffness has also been demonstrated in patients with psoriasis and PsA compared with controls. In PsA, criteria for minimal disease activity (MDA) have been developed and validated. These criteria use 7 measurements including entheseal and skin assessments. Achieving MDA by these criteria results in less radiographic damage in the long term. The development of this instrument is a step toward 'treatment to target' in PsA. MDA is achieved in 48-60% of patients at ≥ 1 visit, and is sustained for ≥ 12 months (sustained MDA) in at least one third of PsA patients in a large observational cohort.
While achieving MDA may result in significant benefits in articular disease, little is known about its effect on extra-articular disease, including CVD risk. The use of surrogate end points instead of actual CV events may provide more evidence on whether PsA patients may benefit from potent anti-inflammatory treatment on the prevention of premature atherosclerosis. Data from our group and others linked the suppression of inflammation using anti-tumour necrosis factor (anti-TNF) with a favourable effect on CV surrogate makers, including carotid IMT and arterial stiffness. More recently, a tight-control treatment strategy aiming at remission was effective in improving arterial stiffness in our early rheumatoid arthritis (RA) cohort. There is an imperative need for interventional trials with CV end points to investigate whether achievement of MDA by a protocolized treatment strategy could reduce CVD risk in PsA. To fill in these gaps of knowledge, we propose a prospective cohort study to ascertain whether achieving MDA through a protocolized treatment strategy may prevent long term progression of IMT and arterial stiffness to a greater extent than those who cannot achieve MDA in patients with PsA.
Aim of the study:
Primary outcome:
- Effect of achieving MDA (MDA group) at 12 months on the progression of subclinical atherosclerosis over a period of 24 months as evaluated by IMT compared to those who cannot achieve MDA (non-MDA group)
Secondary outcomes:
- Changes in arterial stiffness over a period of 24 months as evaluated by pulse wave velocity (PWV) and augmentation Index (AIx) between the MDA group and non-MDA group.
- The proportion of patients achieving sustained MDA (from 12 to 24 months)
- Changes in IMT and arterial stiffness over a period of 24 months as evaluated by IMT, PWV and AIx between patients who can achieve sustained MDA and those who cannot achieve sustained MDA.
- Correlations between the changes in IMT, PWV, and AIX and the changes in markers of disease activity
Hypothesis:
Effective suppression of inflammation in PsA patients who can achieve MDA will have less progression of subclinical atherosclerosis and arterial stiffness than patients who cannot achieve MDA by means of a protocolized treatment algorithm
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PsA MDA | Other | Other: PsA MDA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PsA attending the outpatient clinic of the Prince of Wales Hospital (PWH) who fulfilled the Classification of Psoriatic Arthritis criteria
Key exclusion criteria (1 listed)
- 1) have a history of overt CVD (myocardial infarction, percutaneous transluminal coronary angioplasty, surgery for ischemic heart disease, stroke, transient ischemic attack, carotid endarterectomy, peripheral arterial reconstructive surgery, or limb amputation), or 2) are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI), or 3) have significant co-morbidities including severe renal impairment defined as a glomerular filtration rate of less than 30 mL/min/1.73m2, alanine aminotransferase (ALT) ≥2xULN, hemoglobin level <8.5gm/dl, white blood cell count <3.5x109/liter, platelet count<100x109/liter, or 4) female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women, or 5) they are on glucocorticoids at a dose >10mg/day (equivalent dose of prednisolone)
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 |
|---|---|---|
| PsA MDA | Other | PsA MDA |
Primary outcome
PsA MDA and subclinical atherosclerosis
Time frame: 30 months
Effect of achieving MDA (MDA group) at 12 months on the progression of subclinical atherosclerosis over a period of 24 months as evaluated by IMT compared to those who cannot achieve MDA (non-MDA group).
4 secondary outcomes
PsA MDA and arterial stiffness
Time frame: 30 months
PsA MDA rate
Time frame: 30 months
PsA sustained MDA and atherosclerosis and arterial stiffness
Time frame: 30 month
PsA atherosclerosis and arterial stiffness
Time frame: 30 months
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 19 Jul 2018.
- Derived from this study: PubMed 30144299Cheng IT, Shang Q, Li EK, Wong PC, Kun EW, Law MY, Yip RM, Yim IC, Lai BT, Ying SK, Kwok KY, Li M, Li TK, Zhu TY, Lee JJ, Chang MM, Szeto CC, Yan BP, Lee AP, Tam LS. Effect of Achieving Minimal Disease Activity on the Progression of Subclinical Atherosclerosis and Arterial Stiffness: A Prospective Cohort Study in Psoriatic Arthritis. Arthritis Rheumatol. 2019 Feb;71(2):271-280. doi: 10.1002/art.40695. Epub 2019 Jan 5.
- Derived from this study: PubMed 28052860Shen J, Wong KT, Cheng IT, Shang Q, Li EK, Wong P, Kun EW, Law MY, Yip R, Yim I, Ying S, Li M, Li TK, Wong CK, Zhu TY, Lee JJ, Chang M, Lee AP, Tam LS. Increased prevalence of coronary plaque in patients with psoriatic arthritis without prior diagnosis of coronary artery disease. Ann Rheum Dis. 2017 Jul;76(7):1237-1244. doi: 10.1136/annrheumdis-2016-210390. Epub 2017 Jan 4.
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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 study testing PsA MDA in people with Psoriatic Arthritis and Atherosclerosis, run by Chinese University of Hong Kong 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 1 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: finished, as of the sponsor's last update on 19 Jul 2018. 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?
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?
PsA MDA and subclinical atherosclerosis (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232321, which also lists 2 linked publications.
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 19 Jul 2018.