Early RA Vascular Randomised Controlled Study

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014