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

Recruiting

Conditions: 10023213
joint inflammation
rheumatoid arthritis
10003816

Registration Number: NL-OMON53234

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 340

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 <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 8) or the
rheumatologist*s opinion. 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, both
in case of aiming for remission or LDA).
- 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 a 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome of this trial is the proportion of patients that score<br /><br>positive for the dichotomous composite outcome for clinical and radiological<br /><br>remission. This composite measure includes:<br /><br>- radiographic progression <= 1 SENS score point<br /><br>- <=1 swollen joints detected during joint count<br /><br>- Positive patient acceptable symptom state (PASS)</p><br>

Secondary Outcome Measures