NCT06046950

TrEatment Targets in Rheumatoid Arthritis: TETRA-study

TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Treatment target DAS28CRP-LDA	Aiming for DAS28CRP-low disease activity
OTHER	Treatment target SDAI-remission	Aiming for SDAI-remission

Timeline

• Start date: 2023-12-20
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2023-09-21
• Last updated: 2025-09-11

Locations

1 site across 1 country: Netherlands