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Completed

NCT Number: NCT01768923

Early RA Vascular Randomised Controlled Study

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDAI remission

Procedure

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

Minimal disease activity remission

Procedure

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

Primary outcomes

  1. The change in PWV over 1-year of treatment

    Time frame: Baseline and 12 months

    The change in PWV over 1-year of treatment

Secondary outcomes

  1. The proportion of patients achieve clinical remission

    Time frame: 12 months

    The proportion of patients achieve clinical remission (SDAI</= 3.3 or DAS28<2.6) after 1-year treatment

  2. The proportion of patients with a good response

    Time frame: 12 months

    According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2

  3. ACR 20, 50, 70 responses

    Time frame: 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)

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

    Time frame: Baseline and 12 months

    Change in augmentation index over 1-year of treatment

  5. The change in AIx@75 and PWV over 5-year of treatment

    Time frame: Baseline and 5-year

    long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2013
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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