Clinical trial NCT01768923: 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
Overall status: COMPLETED
Phase: NA
Conditions: Early Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis
Arterial stiffness
SDAI remission group
Minimal disease activity remission group
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in PWV over 1-year of treatment
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: The proportion of patients achieve clinical remission
timeFrame: 12 months
measure: The proportion of patients with a good response
timeFrame: 12 months
measure: ACR 20, 50, 70 responses
timeFrame: 12 months
measure: The change in Alx@75 over 1-year of treatment
timeFrame: Baseline and 12 months
measure: The change in AIx@75 and PWV over 5-year of treatment
timeFrame: Baseline and 5-year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Lai Shan Tam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.