Vascular Effects of Achieving Minimal Disease Activity in Psoriatic Arthritis - a 2 Year Prospective Cohort Study

NCT02232321 | Completed

• 1 other identifier: PsA-MDA
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriatic Arthritis; Atherosclerosis; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

PsA MDA

OTHER

Other: PsA MDA

Interventions

PsA MDA OTHER

PsA MDA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PsA attending the outpatient clinic of the Prince of Wales Hospital (PWH) who fulfilled the Classification of Psoriatic Arthritis criteria

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (2)

• 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.

  PMID: 30144299 DERIVED

• 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.

  PMID: 28052860 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Atherosclerosis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

CN (1)