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Sponsor study identifier
interventional
113
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2017
Actual (reported)Study Completion
May 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2, 2014
Actual (reported)September 5, 2014
Actual (reported)October 2017
Actual (reported)May 2018
Actual (reported)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).
30 months
PsA MDA and arterial stiffness
30 months
PsA MDA rate
30 months
PsA sustained MDA and atherosclerosis and arterial stiffness
30 month
PsA atherosclerosis and arterial stiffness
30 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Prince of Wales Hospital
Hong Kong, China
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.
Shen 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.
113 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2014
First Posted
September 5, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2017
Actual (reported)Study Completion
May 2018
Actual (reported)Last Updated
July 19, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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