Evaluating treatment targets in rheumatoid arthritis
TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study
This study is testing which treatment goal works better for people with rheumatoid arthritis: a lower disease activity score or aiming for complete remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Locations | 1 site (Ubbergen) |
| Trial ID | NCT06046950 on ClinicalTrials.gov |
What this trial studies
This study focuses on optimizing treatment strategies for rheumatoid arthritis (RA) by comparing two treatment targets: the Disease Activity Score with 28-joint counts and c-reactive protein (DAS28CRP) low-disease activity target and the more stringent Simplified Disease Activity Index (SDAI) remission target. The proactive treatment approach, known as treat to target (T2T), aims to lower disease activity by adjusting treatment based on measured outcomes until specific goals are achieved. The study seeks to determine which target is more effective in managing RA symptoms and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 years or older with a diagnosis of rheumatoid arthritis and low disease activity.
Not a fit: Patients in clinical deep remission or those with limited treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with rheumatoid arthritis, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown that treat to target strategies can improve outcomes in rheumatoid arthritis, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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
Where this trial is running
Ubbergen
- Sint Maartenskliniek — Ubbergen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Alfons Den Broeder, MD, PhD — Sint Maartenskliniek
- Study coordinator: Pauline Groenen, MD, MSc
- Email: p.groenen@maartenskliniek.nl
- Phone: 0031243272807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.