NCT01768923

Early RA Vascular Randomised Controlled Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

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.

Conditions

• Early Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	SDAI remission	SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score \[SDAI\] \<3.3)
PROCEDURE	Minimal disease activity remission	Minimal disease activity group aims at minimal disease activity (DAS28\<2.6) (minimal disease activity group)

Timeline

• Start date: 2012-10-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2013-01-16
• Last updated: 2023-09-06

Locations

1 site across 1 country: China