Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDAI remission group | Active Comparator | SDAI remission |
|
| Minimal disease activity group | Active Comparator | Minimal disease activity remission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDAI remission | Procedure | SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in PWV over 1-year of treatment | The change in PWV over 1-year of treatment | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieve clinical remission | The proportion of patients achieve clinical remission (SDAI\ | 12 months |
| The proportion of patients with a good response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lai Shan Tam, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36774444 | Derived | Yue J, Wong PCH, Zhang Y, Peng F, Griffith JF, Xu J, Xiao F, Li TK, Hung V, Qin L, Tam LS. A novel visceral adiposity index predicts bone loss in female early rheumatoid arthritis patients detected by HR-pQCT. Sci Rep. 2023 Feb 11;13(1):2471. doi: 10.1038/s41598-023-29505-z. | |
| 29764965 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Minimal disease activity remission | Procedure | Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group) |
|
According to EULAR definition, good response is DAS28 < 3.2 and a fall in score from baseline by > 1.2
| 12 months |
| 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 |
| The change in Alx@75 over 1-year of treatment | Change in augmentation index over 1-year of treatment | Baseline and 12 months |
| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |