Early RA Vascular Randomised Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early RA MRI Early Intensive Treatment Study

NCT01762176

Early Rheumatoid Arthritis

COMPLETED NA

Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

NCT04324892

Rheumatoid Arthritis

UNKNOWN

Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

NCT00555230

Rheumatoid Arthritis

COMPLETED PHASE2

Vascular Effects of Achieving Minimal Disease Activity in Psoriatic Arthritis - a 2 Year Prospective Cohort Study

NCT02232321

Psoriatic Arthritis Atherosclerosis Arterial Stiffness

COMPLETED NA

Integrated Care Approach for Rheumatoid Arthritis Patients

NCT06791980

Rheumatoid Arthritis (RA)

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Early Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SDAI remission group

SDAI remission

Group Type ACTIVE_COMPARATOR

SDAI remission

Intervention Type PROCEDURE

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

Minimal disease activity group

Minimal disease activity remission

Group Type ACTIVE_COMPARATOR

Minimal disease activity remission

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SDAI remission

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

Intervention Type PROCEDURE

Minimal disease activity remission

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No