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TrEatment Targets in Rheumatoid Arthritis: TETRA-study

Study acronym: TETRA
StatusActive, Not Recruiting
PhaseNot applicable
Started2023-12-20
View on ClinicalTrials.gov ↗

Amendment history

2025-09-04
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v3
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-12→2027-02
Completion date2026-12→2027-02
Study sitesdetails revised at 1 of 1 site
2024-02-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-11→2026-12
Completion date2027-03→2026-12
Start dateestimated 2023-11→confirmed 2023-12-20
Study sites0→1
2023-10-04
Study Identification, Study Status, Eligibility v1
Eligibility criteria+273 characters
[...] R/ EULAR classification criteria and/or clinical diagnosis) (Starting) use of a DMARD Aged 1816 years or older At most low disease activity, operationalise [...] 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, [...] uestionnaires Provided informed consent Exclusion Criteria: 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 [...]
Study title-59 characters
TrEatment Targets in Rheumatoid Arthritis: a Randomized MultiTETRA-centre, Treat to Target Strategy Trial: TETRA Studystudy
2023-09-13
Original filing
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.
Trial Details
NCT Number NCT06046950
Lead Sponsor Sint Maartenskliniek
Conditions Rheumatoid Arthritis
Enrollment 340 participants
Start Date 2023-12-20
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-11