Prince of Wales Hospital
Hong Kong, China
NCT Number: NCT01768923
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
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Interventional
Not applicable
Hong Kong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)
Time frame: Baseline and 12 months
The change in PWV over 1-year of treatment
Time frame: 12 months
The proportion of patients achieve clinical remission (SDAI</= 3.3 or DAS28<2.6) after 1-year treatment
Time frame: 12 months
According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2
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)
Time frame: Baseline and 12 months
Change in augmentation index over 1-year of treatment
Time frame: Baseline and 5-year
long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.
Chinese University of Hong Kong
Other
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
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