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Early RA Vascular Randomised Controlled Study

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ClinicalTrials.gov Identifier: NCT01768923
Recruitment Status : Recruiting
First Posted : January 16, 2013
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

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
Early Rheumatoid Arthritis Procedure: SDAI remission Procedure: Minimal disease activity remission

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 1-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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)

Outcome Measures

Primary Outcome Measures :
  1. The change in PWV over 1-year of treatment [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768923

Contact: Lai Shan Tam, MD 00852-2632 3996 lstam@cuhk.edu.hk

Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Lai Shan Tam, MD    00852-2632 3996      
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Lai Shan Tam, MD Chinese University of Hong Kong
More Information

Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01768923     History of Changes
Other Study ID Numbers: ERA-Alx-2012
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Lai-Shan Tam, Chinese University of Hong Kong:
Early Rheumatoid Arthritis
Arterial stiffness
SDAI remission group
Minimal disease activity remission group

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases