Status:

ACTIVE_NOT_RECRUITING

TrEatment Targets in Rheumatoid Arthritis: TETRA-study

Lead Sponsor:

Sint Maartenskliniek

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

16+ years

Phase:

NA

Brief 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 calle...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

December 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2027

Estimated Enrollment :

340 Patients enrolled

Trial Details

Trial ID

NCT06046950

Start Date

December 20 2023

End Date

February 1 2027

Last Update

September 11 2025

Active Locations (1)

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1

Sint Maartenskliniek

Ubbergen, Netherlands, 6574 NA