Early RA Vascular Randomised Controlled Study

This study is currently recruiting participants.
Verified January 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01768923
First received: January 3, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The change in Alx@75 over 1-year of treatment [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of patients achieve clinical remission [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768923

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

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

No publications provided

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
Study First Received: January 3, 2013
Last Updated: January 14, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 17, 2014