Early RA Vascular Randomised Controlled Study
Primary Purpose
Early Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SDAI remission
Minimal disease activity remission
Sponsored by

About this trial
This is an interventional treatment trial for Early Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group
Eligibility 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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SDAI remission group
Minimal disease activity group
Arm Description
SDAI remission
Minimal disease activity remission
Outcomes
Primary Outcome Measures
The change in PWV over 1-year of treatment
The change in PWV over 1-year of treatment
Secondary Outcome Measures
The proportion of patients achieve clinical remission
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
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
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)
The change in Alx@75 over 1-year of treatment
Change in augmentation index over 1-year of treatment
The change in AIx@75 and PWV over 5-year of treatment
long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.
Full Information
NCT ID
NCT01768923
First Posted
January 3, 2013
Last Updated
September 4, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01768923
Brief Title
Early RA Vascular Randomised Controlled Study
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. 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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SDAI remission group
Arm Type
Active Comparator
Arm Description
SDAI remission
Arm Title
Minimal disease activity group
Arm Type
Active Comparator
Arm Description
Minimal disease activity remission
Intervention Type
Procedure
Intervention Name(s)
SDAI remission
Intervention Description
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
Intervention Type
Procedure
Intervention Name(s)
Minimal disease activity remission
Intervention Description
Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)
Primary Outcome Measure Information:
Title
The change in PWV over 1-year of treatment
Description
The change in PWV over 1-year of treatment
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
The proportion of patients achieve clinical remission
Description
The proportion of patients achieve clinical remission (SDAI</= 3.3 or DAS28<2.6) after 1-year treatment
Time Frame
12 months
Title
The proportion of patients with a good response
Description
According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2
Time Frame
12 months
Title
ACR 20, 50, 70 responses
Description
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)
Time Frame
12 months
Title
The change in Alx@75 over 1-year of treatment
Description
Change in augmentation index over 1-year of treatment
Time Frame
Baseline and 12 months
Title
The change in AIx@75 and PWV over 5-year of treatment
Description
long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years.
Time Frame
Baseline and 5-year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Shan Tam, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29764965
Citation
Tam LH, Shang Q, Li EK, Wong PC, Kwok KY, Kun EW, Yim IC, Lee VK, Yip RM, Pang SH, Lao VW, Mak QW, Cheng IT, Lau XS, Li TK, Zhu TY, Lee AP, Tam LS. Effect of Treat-to-target Strategies Aiming at Remission of Arterial Stiffness in Early Rheumatoid Arthritis: A Randomized Controlled Study. J Rheumatol. 2018 Aug;45(9):1229-1239. doi: 10.3899/jrheum.171128. Epub 2018 May 15.
Results Reference
derived
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Early RA Vascular Randomised Controlled Study
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