Open label Phase IIIb study to evaluate the efficacy and safety of subcutaneous (SC) Tocilizumab monotherapy or combination therapy with methotrexate (MTX) or other non-biologic disease modifying ant-rheumatic drugs (DMARD’s) in patients with active Rheumatoid Arthritis (RA) who have an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (ant-TNF) biologic agent The primary objective of this study is to assess the efficacy of switching to SC Tocilizumab (as monotherapy or in combination with MTX or other non-biologic DMARD’s) in patients who have had an inadequate response to current non-biologic DMARD therapy or the first anti-TNF biologic agent ( as monotherapy or in combination with MTX or other non-biologic DMARD’s). Inadequate response to anti-TNF treatment is assessed at week 24 or after a minimum period of 12 weeks of therapy if permitted by local guidance (either defined by NICE as a Disease Activity Score 28 (DAS 28) improvement of less than 1.2 or patients not achieving a DAS28 of≤ 3.2 according to a treat-to-target strategy). Efficacy will be measured by DAS28 ESR and Clinical Disease Activity Index (CDAI) at every visit up to week 52 Chief Investigator: Dr Neil McKay Number and location of participating sites (by region/ country): Multiple sites throughout the UK EudraCT number: 2013-000054-22 Funder: Roche Products Ltd Start and End date of grant award: Jan-2014 to Sep 2016 Current Status: Complete. Contact details: Sponsor - Roche Products Ltd Dr Neil McKay, Consultant Rheumatologist, Rheumatology Department, Western General Hospital, Crewe Road South, Edinburgh. Debbie Alexander, Trial Team Manager (Clinical). ECTU Involvement: Research Nurses This article was published on 2024-09-24
