Early RA Vascular Randomised Controlled Study

Not Applicable

Completed

• Conditions: Early Rheumatoid Arthritis
• Interventions: Procedure: Minimal disease activity remission; Procedure: SDAI remission

• Registration Number: NCT01768923
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal disease activity group	Minimal disease activity remission	Minimal disease activity remission
SDAI remission group	SDAI remission	SDAI remission

Primary Outcome Measures

Name	Time	Method
The change in PWV over 1-year of treatment	Baseline and 12 months	The change in PWV over 1-year of treatment

Secondary Outcome Measures

Name	Time	Method
The proportion of patients achieve clinical remission	12 months	The proportion of patients achieve clinical remission (SDAI\</= 3.3 or DAS28\<2.6) after 1-year treatment
The proportion of patients with a good response	12 months	According to EULAR definition, good response is DAS28 \< 3.2 and a fall in score from baseline by \> 1.2
ACR 20, 50, 70 responses	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)
The change in Alx@75 over 1-year of treatment	Baseline and 12 months	Change in augmentation index over 1-year of treatment
The change in AIx@75 and PWV over 5-year of treatment	Baseline and 5-year	long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China