Early RA Vascular Randomised Controlled Study

Chinese University of Hong Kong120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Early Rheumatoid Arthritis

Interventions

SDAI remissionPROCEDURE

SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score \[SDAI\] \<3.3)

Minimal disease activity remissionPROCEDURE

Minimal disease activity group aims at minimal disease activity (DAS28\<2.6) (minimal disease activity group)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital

Hong Kong, China

Outcomes

Primary Outcomes

The change in PWV over 1-year of treatment

Time frame: Baseline and 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 12 months

The change in Alx@75 over 1-year of treatment

Change in augmentation index over 1-year of treatment

Time frame: 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.

Time frame: Baseline and 5-year

Data from ClinicalTrials.gov

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