An interventional study of Treatment target DAS28CRP-LDA and Treatment target SDAI-remission in Rheumatoid Arthritis, sponsored by Sint Maartenskliniek. Active, not recruiting at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Sint Maartenskliniek · Not applicable, Interventional, and Treatment
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 340 is above the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sint Maartenskliniek is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm that is allocated to strive for DAS28CRP low disease activity (LDA)
Other: Treatment target DAS28CRP-LDA
Arm that is allocated to strive for SDAI-remission
Other: Treatment target SDAI-remission
Aiming for DAS28CRP-low disease activity
Aiming for SDAI-remission
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.
Time frame: 18 months follow-up time point
The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms
Time frame: 18 months follow-up
The number of swollen joints at 18 months follow-up
Time frame: 18 months follow-up
The proportion of patients achieving 'patient acceptable symptom state' (PASS)
Time frame: 18 months follow-up
The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission)
Time frame: 18 months follow-up
Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm
Time frame: 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.
Time frame: 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.
Time frame: 18 months follow-up
Incidence density rates of safety ((serious) adverse events, according to CTCAE criteria version 5.0)
Time frame: 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
Time frame: 18 months follow-up
Costs associated with medical consumption as assessed with the 'Institute for Medical Technology Assessment Medical Consumption Questionnaire' (iMCQ)
Time frame: 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.
Time frame: 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.
Time frame: 18 months follow-up
The incidence density rate of flares
Time frame: 18 months follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sint Maartenskliniek