Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis — TOVERA  

Rheumatoid Arthritis Clinical Trial

Official title: Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)

Status Recruiting

Clinical Trial Summary

This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate (MTX).

Clinical Trial Description

For most rheumatic autoimmune diseases, treatment has two components: induction of remission and maintenance (to prevent relapse). After screening (week -3 to 0), patients enter into a 3 week run-in period during which no glucocorticoid (GC) treatment is allowed. At week 0, if persistent synovitis is confirmed patients will enter the induction phase. During the induction phase all patients will receive TCZ and MTX from week 0 to week 24. After week 24, all patients will receive MTX.

Ultrasound (US) is increasingly used in rheumatic diseases, in particular in rheumatoid arthritis (RA). The great resolution of superficial musculoskeletal structures obtained by using high frequency transducers and the high sensitivity of colour Doppler (CD) and power Doppler (PD) techniques allow to detect synovial vascularisation, synovial hypertrophy (SH) and joint effusion (JE).

This is a pilot US trial that allow us to explore the hypothesis that an early US response may be predictive of later clinical response. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT02837146
• Study type: Interventional
• Source: Université Catholique de Louvain
• Contact: Maria S Stoenoiu, MD, PhD
• Phone: +32 2 7645391
• Email: maria.stoenoiu@uclouvain.be
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2015
• Completion date: December 2019