TrEatment Targets in Rheumatoid Arthritis: TETRA-study

NCT ID: NCT06046950

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2027-02-28

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAS28CRP-LDA

Arm that is allocated to strive for DAS28CRP low disease activity (LDA)

Group Type: EXPERIMENTAL

Treatment target DAS28CRP-LDA

Intervention Type: OTHER

Aiming for DAS28CRP-low disease activity

SDAI-remission

Arm that is allocated to strive for SDAI-remission

Group Type: EXPERIMENTAL

Treatment target SDAI-remission

Intervention Type: OTHER

Aiming for SDAI-remission

Interventions

Treatment target DAS28CRP-LDA

Aiming for DAS28CRP-low disease activity

Intervention Type: OTHER

Treatment target SDAI-remission

Aiming for SDAI-remission

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfons Den Broeder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Locations

Sint Maartenskliniek

Ubbergen, , Netherlands

Countries

Netherlands

Other Identifiers

TETRA

Identifier Type: -

Identifier Source: org_study_id