Early RA Vascular Randomised Controlled Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Early Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: SDAI remission
* Procedure: Minimal disease activity remission


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SDAI remission group<br>SDAI remission | Procedure: SDAI remission<br>* SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)<br>|
| Active Comparator: Minimal disease activity group<br>Minimal disease activity remission | Procedure: Minimal disease activity remission<br>* Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in PWV over 1-year of treatment | The change in PWV over 1-year of treatment | Baseline and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group