Rheumatoid ArthritisTETRANCT06046950
TrEatment Targets in Rheumatoid Arthritis: TETRA-study
A study testing Treatment target DAS28CRP-LDA and Treatment target SDAI-remission in people with Rheumatoid Arthritis, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Treatment target DAS28CRP-LDA and Treatment target SDAI-remission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Dec 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteria and/or clinical diagnosis)
- (Starting) use of a DMARD
- Aged 16 years or older
- At most low disease activity, operationalised as DAS28-CRP <3.5 (DAS28 CRP 2.9 cut off for low disease activity with measurement error 0.6) or SDAI <19 (SDAI 11 cut off for low disease activity with measurement error of 8). A state of low disease activity is required at inclusion, as for RA patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated).
- Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
- Provided informed consent
Who cannot join
- Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP <2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare.
- Fewer than 3 DMARD treatment options left for this patient (severe difficult-to-treat or refractory RA)
- Current severe comorbidity or other serious life-shortening conditions hampering trial participation
- Inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Treatment target DAS28CRP-LDA, Treatment target SDAI-remission
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment target DAS28CRP-LDAOther
Aiming for DAS28CRP-low disease activity
Treatment target SDAI-remissionOther
Aiming for SDAI-remission
| Study group | Role | What they receive |
|---|---|---|
| DAS28CRP-LDA | Experimental | Arm that is allocated to strive for DAS28CRP low disease activity (LDA) Receives: Other: Treatment target DAS28CRP-LDA |
| SDAI-remission | Experimental | Arm that is allocated to strive for SDAI-remission Receives: Other: Treatment target SDAI-remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months follow-up time point
Secondary outcomes (13)
The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms
Measured: 18 months follow-up
The number of swollen joints at 18 months follow-up
Measured: 18 months follow-up
The proportion of patients achieving 'patient acceptable symptom state' (PASS)
Measured: 18 months follow-up
The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission)
Measured: 18 months follow-up
Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm
Measured: 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.
Measured: 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.
Measured: 18 months follow-up
Incidence density rates of safety ((serious) adverse events, according to CTCAE criteria version 5.0)
Measured: 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
Measured: 18 months follow-up
Costs associated with medical consumption as assessed with the 'Institute for Medical Technology Assessment Medical Consumption Questionnaire' (iMCQ)
Measured: 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.
Measured: 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.
Measured: 18 months follow-up
The incidence density rate of flares
Measured: 18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Dec 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfons Den Broeder, MD, PhD, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046950
- Sponsor's protocol ID
- TETRA
- Acronym
- TETRA
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study
- ClinicalTrials.gov ID
- NCT06046950
- Acronym / sponsor ID
- TETRA / TETRA
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAS28CRP-LDA | Experimental | Other: Treatment target DAS28CRP-LDAArm that is allocated to strive for DAS28CRP low disease activity (LDA) |
| SDAI-remission | Experimental | Other: Treatment target SDAI-remissionArm that is allocated to strive for SDAI-remission |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteria and/or clinical diagnosis)
- (Starting) use of a DMARD
- Aged 16 years or older
- At most low disease activity, operationalised as DAS28-CRP <3.5 (DAS28 CRP 2.9 cut off for low disease activity with measurement error 0.6) or SDAI <19 (SDAI 11 cut off for low disease activity with measurement error of 8). A state of low disease activity is required at inclusion, as for RA patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated).
- Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
Key exclusion criteria (4 listed)
- Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP <2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare.
- Fewer than 3 DMARD treatment options left for this patient (severe difficult-to-treat or refractory RA)
- Current severe comorbidity or other serious life-shortening conditions hampering trial participation
- Inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment target DAS28CRP-LDAAiming for DAS28CRP-low disease activity | Other | DAS28CRP-LDA |
| Treatment target SDAI-remissionAiming for SDAI-remission | Other | SDAI-remission |
Primary outcome
Achievement of the composite clinical/radiological remission outcome
Time frame: 18 months follow-up time point
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.
13 secondary outcomes
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)
Time frame: 18 months follow-up
Quality of life (QoL) as defined by the 'EuroQol 5 Dimensions with 5 levels' (EQ5D-5L) questionnaire
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)
Time frame: 18 months follow-up
Proportion of patients of whom the rheumatologist adhered to the local guidelines to treat the patients
Time frame: 18 months follow-up
The incidence density rate of flares
Time frame: 18 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfons Den Broeder, MD, PhD principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment target DAS28CRP-LDA and Treatment target SDAI-remission in people with Rheumatoid Arthritis, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the composite clinical/radiological remission outcome (time frame: 18 months follow-up time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.