Early RA Vascular Randomised Controlled Study

September 4, 2023 updated by: Lai-Shan Tam, Chinese University of Hong Kong

Effect of Treat-to-target Strategies Aiming at Remission Compared With Minimal Disease Activity on Arterial Stiffness in Early Rheumatoid Arthritis - a Randomised Controlled Study

To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.

To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred RA patients with active disease (DAS28 >/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial.

All participants will receive 1-year tight-control treatment. One hundred patients will be randomly assigned to two arms. Treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 ACR/EULAR definition (Group 1, n=50, simplified disease activity score [SDAI] ≤3.3) or minimal disease activity (Group 2, n=50, DAS28<2.6). A follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • fulfilled the 2010 ACR/EULAR classification criteria for RA
  • have symptoms onset of less than 2 years
  • have active disease (DAS28> 3.2)
  • are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies

Exclusion Criteria:

  • have a history of overt cardiovascular diseases
  • are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
  • have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
  • have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
  • on glucocorticoids at a dose >10mg/day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SDAI remission group
SDAI remission
Procedure: SDAI remission
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
Active Comparator: Minimal disease activity group
Minimal disease activity remission
Procedure: Minimal disease activity remission
Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in PWV over 1-year of treatment
Time Frame: Baseline and 12 months
The change in PWV over 1-year of treatment
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients achieve clinical remission
Time Frame: 12 months
The proportion of patients achieve clinical remission (SDAI</= 3.3 or DAS28<2.6) after 1-year treatment
12 months
The proportion of patients with a good response
Time Frame: 12 months
According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2
12 months
ACR 20, 50, 70 responses
Time Frame: 12 months
ACR 20, 50, 70 responses defined as at least 20%, 50%, 70% improvement in joint swelling and joint tenderness counts, and three of five other variables (i.e. ESR or CRP, HAQ score, pain score and physicians' and patients' global assessments)
12 months
The change in Alx@75 over 1-year of treatment
Time Frame: Baseline and 12 months
Change in augmentation index over 1-year of treatment
Baseline and 12 months
The change in AIx@75 and PWV over 5-year of treatment
Time Frame: Baseline and 5-year
long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.
Baseline and 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Lai Shan Tam, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimated)

January 16, 2013

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERA-Alx-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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