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

NCT02232321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2018-07-19

No results posted yet for this study

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

Interventions

OTHER

PsA MDA

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-10-31
Completion
2018-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232321 on ClinicalTrials.gov