Early Rheumatoid Arthritis
Conditions
Keywords
Early Rheumatoid Arthritis, Arterial stiffness, SDAI remission group, Minimal disease activity remission group
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.
Interventions
PROCEDURESDAI remission
SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score \[SDAI\] \<3.3)
PROCEDUREMinimal disease activity remission
Minimal disease activity group aims at minimal disease activity (DAS28\<2.6) (minimal disease activity group)
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in PWV over 1-year of treatment | Baseline and 12 months | The change in PWV over 1-year of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieve clinical remission | 12 months | 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 | 12 months | 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 | 12 months | 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 | Baseline and 12 months | Change in augmentation index over 1-year of treatment |
| The change in AIx@75 and PWV over 5-year of treatment | Baseline and 5-year | long term effect on vascular outcomes (including changes in PWV and AIx) after 5 years. |
Countries
China
Outcome results
None listed