Early RA Vascular Randomised Controlled Study

Early Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768923
• Other study ID #: ERA-Alx-2012
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: June 2022

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Early Rheumatoid Arthritis

Intervention

Procedure:
• SDAI remission
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
• Minimal disease activity remission
Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in PWV over 1-year of treatment	The change in PWV over 1-year of treatment	Baseline and 12 months
Secondary	The proportion of patients achieve clinical remission	The proportion of patients achieve clinical remission (SDAI	12 months
Secondary	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	12 months
Secondary	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)	12 months
Secondary	The change in Alx@75 over 1-year of treatment	Change in augmentation index over 1-year of treatment	Baseline and 12 months
Secondary	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.	Baseline and 5-year