The TREMERA study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (RA). Recent international treatment recommendations emphasise the need to diagnose RA early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. Remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. Tocilizumab (TCZ) is a newly introduced biologic drug that is used in established RA. The TREMERA study primarily aims to investigate the biological changes seen in blood and tissue following TCZ therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as TCZ can also switch off immunological parameters associated with a disrupted immune system of RA. The study will assess the effectiveness of TCZ given on its own or in combination with methotrexate (MTX; a standard therapy usually given with biologic treatments)in patients with early onset RA to determine the proportion that achieve remission. This study also aims to find out how quickly remission can be achieved with TCZ and the depth of remission achieved. This will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (MRI) which can detect inflammation not apparent on clinical assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Evaluate change in expression of JAK 1 and 3 (as well as STAT and p38 MAPK).
Changes up to week 60
Time frame: To week 60
Reduction in inflammation in each treatment arm using ultrasound
Establish reduction in inflammation in each treatment arm using ultrasound using grey scale power doppler
Time frame: To week 48
Disease Activity Score (DAS): DAS28/44 remission
Proportion of patients achieving DAS28/44 remission
Time frame: To week 48
Questionnaires and research tools
Using tools including DAS28/44, SDAI, CDAI
Time frame: Week 48
Health Assessment Questionniaire (HAQ) scores
The change from baseline in HAQ scores.
Time frame: To week 48
VAS scores questionnaire
The change in VAS scores for pain, disease activity
Time frame: To week 48
Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire
The change in RAQoL from baseline
Time frame: To week 48
Bone densitometry
Bone densitometry scan of hands, spine, femoral neck
Time frame: Week 48.
Sharp score on plain radiographs
Change in modified Sharp score on plain radiographs
Time frame: Week 48.
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