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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT01768923
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date June 2022

See also
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Completed NCT00195663 - Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis Phase 3
Completed NCT04752748 - Power Doppler in Hand Joints of Early RA Patients