Clinical trial NCT06046950: TrEatment Targets in Rheumatoid Arthritis: TETRA-study
Official title: TrEatment Targets in Rheumatoid Arthritis: a Randomized Multi-centre, Treat to Target Strategy Trial: TETRA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 340
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Achievement of the composite clinical/radiological remission outcome
timeFrame: 18 months follow-up time point
Secondary outcomes:
measure: The proportion of patients having radiographic progression (defined as > 1 simple erosion narrowing score (SENS) point) in both treatment arms
timeFrame: 18 months follow-up
measure: The number of swollen joints at 18 months follow-up
timeFrame: 18 months follow-up
measure: The proportion of patients achieving 'patient acceptable symptom state' (PASS)
timeFrame: 18 months follow-up
measure: The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission)
timeFrame: 18 months follow-up
measure: Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm
timeFrame: 18 months follow-up
measure: Daily functioning, measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: 18 months follow-up
measure: Quality of life (QoL) as defined by the 'EuroQol 5 Dimensions with 5 levels' (EQ5D-5L) questionnaire
timeFrame: 18 months follow-up
measure: Incidence density rates of safety ((serious) adverse events, according to CTCAE criteria version 5.0)
timeFrame: 18 months follow-up
measure: Drug use of the patients, consisting of the type and volume of antirheumatic drugs (glucocorticoids, DMARDS, NSAIDs) used over the 18 months period, and at 18 months visit
timeFrame: 18 months follow-up
measure: Costs associated with medical consumption as assessed with the 'Institute for Medical Technology Assessment Medical Consumption Questionnaire' (iMCQ)
timeFrame: 18 months follow-up
measure: Costs associated with loss of productivity as measured bij the 'Institute of Medical Technology Assessment Productivity Cost Questionnaire (iMTA PCQ)
timeFrame: 18 months follow-up
measure: Proportion of patients of whom the rheumatologist adhered to the local guidelines to treat the patients
timeFrame: 18 months follow-up
measure: The incidence density rate of flares
timeFrame: 18 months follow-up
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Alfons Den Broeder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: