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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 3, 2013
Last Updated
September 4, 2023
Sponsor
Chinese University of Hong Kong
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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
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Early RA Vascular Randomised Controlled Study

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