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There is currently no cure for rheumatoid arthritis (RA), but many treatment options are available. The central aim of RA treatment is lowering disease activity. The proactive treatment strategy called treat to target (T2T) includes measuring disease activity, setting a target and adjusting treatment accordingly until the goal is reached. T2T has proven to be superior to usual care, but there is much debate regarding the most optimal treatment measure and target. The Disease Activity Score with 28-joint counts and c-reactive protein (DAS28CRP) low-disease activity (LDA) target and the more stringent Simplified Disease Activity Index (SDAI) remission target are the best validated targets. Especially the DAS28CRP is the most commonly used in research and practice, whereas the SDAI remission target is most recommended. The European Alliance of Associations for Rheumatology (EULAR) recommends to strive for remission, whereas the American College of Rheumatology (ACR) recommends to strive for LDA. In patients with new and established RA, the (cost)effectiveness of aiming for remission compared to LDA when starting and tapering antirheumatic drugs has not been directly compared. This study therefore aims to directly compare two T2T strategies, aiming at DAS28CRP-LDA and SDAI remission, in patients with established RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS28CRP-LDA | Experimental | Arm that is allocated to strive for DAS28CRP low disease activity (LDA) |
|
| SDAI-remission | Experimental | Arm that is allocated to strive for SDAI-remission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment target DAS28CRP-LDA | Other | Aiming for DAS28CRP-low disease activity |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of the composite clinical/radiological remission outcome | Achievement of the composite clinical/radiological remission outcome (radiographic progression ≤1 simple erosion narrowing score (SENS), AND, ≤1 swollen joint count, and being in PASS) at 18 months. | 18 months follow-up time point |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms | 18 months follow-up | |
| The number of swollen joints at 18 months follow-up | 18 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfons Den Broeder, MD, PhD | Sint Maartenskliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartenskliniek | Ubbergen | 6574 NA | Netherlands |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Treatment target SDAI-remission |
| Other |
Aiming for SDAI-remission |
|
| The proportion of patients achieving 'patient acceptable symptom state' (PASS) | 18 months follow-up |
| The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission) | 18 months follow-up |
| Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm | 18 months follow-up |
| Daily functioning, measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) | The Health Assessment Questionnaire-Disability Index (HAQ-DI) will be used to measure the impact of the rheumatoid arthritis on daily functioning. A minimum score of 0 and a maximum score of 60 can be scored. A higher score means a higher impact on daily functioning. | 18 months follow-up |
| Quality of life (QoL) as defined by the 'EuroQol 5 Dimensions with 5 levels' (EQ5D-5L) questionnaire | This questionnaire assesses five dimensions of health, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension can be answered on a 5-point scale, ranging from no problems to extreme problems/unable to. A higher score means a worse outcome. | 18 months follow-up |
| Incidence density rates of safety ((serious) adverse events, according to CTCAE criteria version 5.0) | 18 months follow-up |
| Drug use of the patients, consisting of the type and volume of antirheumatic drugs (glucocorticoids, DMARDS, NSAIDs) used over the 18 months period, and at 18 months visit | 18 months follow-up |
| Costs associated with medical consumption as assessed with the 'Institute for Medical Technology Assessment Medical Consumption Questionnaire' (iMCQ) | 18 months follow-up |
| Costs associated with loss of productivity as measured bij the 'Institute of Medical Technology Assessment Productivity Cost Questionnaire (iMTA PCQ) | This is a short generic questionnaire that measures loss of productivity (e.g., both paid and unpaid work) due to illness or recovery. | 18 months follow-up |
| Proportion of patients of whom the rheumatologist adhered to the local guidelines to treat the patients | Clinicians are encouraged to adhere to protocol upfront, and adherence is actively monitored, but treatment decisions are ultimately made using shared decision making between patients and physicians. After study completion, adherence will be assessed through a comparison of the target measurements and any changes in treatment regime made by the rheumatologists. | 18 months follow-up |
| The incidence density rate of flares | 18 months follow-up |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |