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