TrEatment Targets in Rheumatoid Arthritis: TETRA-study

Last updated: September 4, 2025
Sponsor: Sint Maartenskliniek
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Musculoskeletal Diseases

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Treatment

Treatment target SDAI-remission

Treatment target DAS28CRP-LDA

Clinical Study ID

NCT06046950
TETRA
  • Ages > 16
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteriaand/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 cutoff for low disease activity with measurement error 0.6) or SDAI <19 (SDAI 11 cutoff for low disease activity with measurement error of 8). A state of low diseaseactivity is required at inclusion, as for RA patients in moderate or high diseaseactivity there is no equipoise on the best course of action (treatment needs to beescalated).

  • Fluency of Dutch or English, both written and verbally; able to fill inquestionnaires

  • Provided informed consent

Exclusion

Exclusion Criteria:

  • Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP <2.4, and antaper attempt in the past 2 years that was discontinued due to occurrence of flare.

  • Fewer than 3 DMARD treatment options left for this patient (severedifficult-to-treat or refractory RA)

  • Current severe comorbidity or other serious life-shortening conditions hamperingtrial participation

  • Inability to comply with the study protocol or to provide informed consent withregard to intervention control and measuring outcomes

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Treatment target SDAI-remission
Phase:
Study Start date:
December 20, 2023
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Sint Maartenskliniek

    Ubbergen, 6574 NA
    Netherlands

    Site Not Available

  • Sint Maartenskliniek

    Ubbergen 2746012, 6574 NA
    Netherlands

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.