TrEatment Targets in Rheumatoid Arthritis: TETRA-study

NCT06046950 | Active Not Recruiting

• 1 other identifier: TETRA
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Achievement of the composite clinical/radiological remission outcome

  Achievement of the composite clinical/radiological remission outcome (radiographic progression ≤1 simple erosion narrowing score (SENS), AND, ≤1 swollen joint count, and being in PASS) at 18 months.

  18 months follow-up time point

Secondary Outcomes (13)

• The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms

  18 months follow-up

• The number of swollen joints at 18 months follow-up

  18 months follow-up

• The proportion of patients achieving 'patient acceptable symptom state' (PASS)

  18 months follow-up

• The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission)

  18 months follow-up

• Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm

  18 months follow-up

Study Arms (2)

DAS28CRP-LDA

EXPERIMENTAL

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

Other: Treatment target DAS28CRP-LDA

SDAI-remission

EXPERIMENTAL

Arm that is allocated to strive for SDAI-remission

Other: Treatment target SDAI-remission

Interventions

Treatment target DAS28CRP-LDA OTHER

Aiming for DAS28CRP-low disease activity

DAS28CRP-LDA

Treatment target SDAI-remission OTHER

Aiming for SDAI-remission

SDAI-remission

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
• Provided informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, 6574 NA, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alfons Den Broeder, MD, PhD

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 21, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)