Early RA Vascular Randomised Controlled Study

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01768923

Collaborator

(none)

120

Enrollment

Location

Arms

128

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Early Rheumatoid Arthritis	Procedure: SDAI remission Procedure: Minimal disease activity remission	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: SDAI remission group

SDAI remission

Procedure: SDAI remission

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

Active Comparator: Minimal disease activity group

Minimal disease activity remission

Procedure: Minimal disease activity remission

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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