TEEMS
Research type
Research Study
Full title
Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification.
IRAS ID
207599
Contact name
Paul Emery
Contact email
Sponsor organisation
University of Leeds
Eudract number
2016-002344-16
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The current optimal treatment for early rheumatoid arthritis (RA) is to start methotrexate (MTX) to target inflammation and induce remission (absence of clinical signs and symptoms of disease). Prediction of MTX response remains a key clinical need to enable the identification of patients who would benefit from an alternative, more aggressive treatment strategy. Multiple predictors of remission with MTX have been reported over the years, however none have entered routine clinical practice.
We previously reported that baseline T-cell frequency can predict remission in patients treated with MTX. This confirmed that naïve T-cells were predictive of remission. The inability to achieve remission was not observed in patients treated with combination therapy (MTX + biologic/anti-TNF treatment). There is therefore a clinical need for measuring T-cells as a biomarker for managing patients with early RA.
The aim of the study is to determine whether treating patients according to baseline naïve T-cells results in better outcomes at 24 weeks compared to standard clinical practice for patients with newly diagnosed, treatment-naive RA patients.
We propose a phase 4, single-centre, open-label, pilot randomized controlled study that aims to assess whether MTX can be rationalised as a first-line treatment for treatment-naïve early RA patients, based on their baseline naïve T-cells.
Patients with newly diagnosed RA will be stratified into two groups based on their naïve T-cell frequency (normal/abnormal). Patients with a normal T-cell value will commence MTX in line with standard (treat-to-target) care. Patients with an abnormal T-cell frequency will be randomized into 2 groups.
The first group will receive MTX with T2T care and the second group will receive MTX in combination with etanercept.
If the study demonstrates a greater proportion of patients in remission at six months for the combination therapy group, it may be appropriate to consider biologics/anti-TNF therapy earlier in patients with abnormal baseline naïve T-cells.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0155
Date of REC Opinion
21 Jun 2017
REC opinion
Further Information Favourable Opinion