Early RA Vascular Randomised Controlled Study

The Chinese University of Hong Kong

Status

Completed

Conditions

Early Rheumatoid Arthritis

Treatments

Procedure: Minimal disease activity remission

Procedure: SDAI remission

Study type

Interventional

Funder types

Other

Identifiers

NCT01768923

ERA-Alx-2012

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Volunteers

No Healthy Volunteers

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