TrEatment Targets in Rheumatoid Arthritis: a randomized multi-centre, treat to target strategy trial: TETRA study

TrEatment Targets in Rheumatoid Arthritis: a randomized multi-centre, treat to target strategy trial: TETRA study - TETRA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53234

Enrollment

280

Registered

2023-11-06

Start date

2023-12-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

joint inflammation rheumatoid arthritis

Interventions

Patients are randomised towards a treatment target of : 1. Disease Activity Score with 28-joint counts and c-reactive protein (DAS28CRP), low-disease activity target 2. Simplified Disease Activity In

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of RA (according to the 2010 ACR/ EULAR classification criteria and/or clinical diagnosis) - Aged 16 years or older - At most low disease activity, operationalised as DAS28-CRP

Exclusion criteria

Exclusion criteria: - Clinical deep remission, operationalised as SDAI

Design outcomes

Primary

Measure	Time frame
The main outcome of this trial is the proportion of patients that score positive for the dichotomous composite outcome for clinical and radiological remission. This composite measure includes: - radiographic progression	—

Secondary

Measure	Time frame
Secondary outcomes in this study are defined as: 1. All individual parts of the composite primary endpoint including radiographic progression, number of swollen joints and proportion of patients being in PASS at 18 months follow-up 2. The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission) 3. Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm 4. Number of flares that occur in each treatment arm over 18-months follow-up 5. Daily functioning, measured by HAQ DI 6. Physician T2T/Ta2T protocol adherence 7. Drug use of the patients, consisting of the type and volume of antirheumatic drugs (GC, DMARDS, NSAIDs) used over the 18 months period, and at 18 months visit 8. Safety ((serious) adverse events, according to CTCAE criteria version 5.0) 9. Quality of life (QoL) as defined by the EQ5-D-5L questionnaire 10. Costs: volumes of medical costs and productivity loss	—

Measure

Time frame

Secondary outcomes in this study are defined as: 1. All individual parts of the composite primary endpoint including radiographic progression, number of swollen joints and proportion of patients being in PASS at 18 months follow-up 2. The proportion of patients who reach the predefined target for each treatment arm (DAS28CRP-LDA or SDAI remission) 3. Percentage of patients that reach LDA or remission, using DAS28CRP- and SDAI-based definitions, in each treatment arm 4. Number of flares that occur in each treatment arm over 18-months follow-up 5. Daily functioning, measured by HAQ DI 6. Physician T2T/Ta2T protocol adherence 7. Drug use of the patients, consisting of the type and volume of antirheumatic drugs (GC, DMARDS, NSAIDs) used over the 18 months period, and at 18 months visit 8. Safety ((serious) adverse events, according to CTCAE criteria version 5.0) 9. Quality of life (QoL) as defined by the EQ5-D-5L questionnaire 10. Costs: volumes of medical costs and productivity loss

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)