Last updated: February 22, 2024
Sponsor: Sint Maartenskliniek
Overall Status: Active - Recruiting
Phase
N/A
Condition
Rheumatoid Arthritis
Bone Diseases
Musculoskeletal Diseases
Treatment
Treatment target SDAI-remission
Treatment target DAS28CRP-LDA
Clinical Study ID
NCT06046950
TETRA
Ages > 16 All Genders
Study Summary
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 cut offfor low disease activity with measurement error 0.6) or SDAI <19 (SDAI 11 cut off forlow disease activity with measurement error of 8). A state of low disease activity isrequired at inclusion, as for RA patients in moderate or high disease activity thereis 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
Exclusion Criteria:
- Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP <2.4, and an taperattempt 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-treator refractory RA)
- Current severe comorbidity or other serious life-shortening conditions hampering trialparticipation
- Inability to comply with the study protocol or to provide informed consent with regardto 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:
December 31, 2026
Connect with a study center
Sint Maartenskliniek
Ubbergen, 6574 NA
NetherlandsActive - Recruiting
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