Abstract
BackgroundUncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time. ‘Treating to target’ has been shown to be effective in active established disease and also in early disease. However, there is a lack of nationally agreed treatment protocols for patients with established rheumatoid arthritis who have intermediate disease activity. This trial is designed to investigate whether intensive management of disease leads to a greater number of remissions at 12 months. Levels of disability and quality of life, and acceptability and cost-effectiveness of the intervention will also be examined.MethodsThe trial is a 12-month, pragmatic, randomised, open-label, two-arm, parallel-group, multicentre trial undertaken at specialist rheumatology centres across England. Three hundred and ninety-eight patients with established rheumatoid arthritis will be recruited. They will currently have intermediate disease activity (disease activity score for 28 joints assessed using an erythrocyte sedimentation rate of 3.2 to 5.1 with at least three active joints) and will be taking at least one disease-modifying anti-rheumatic drug.Participants will be randomly selected to receive intensive management or standard care. Intensive management will involve monthly clinical reviews with a specialist health practitioner, where drug treatment will be optimised and an individualised treatment support programme delivered based on several principles of motivational interviewing to address identified problem areas, such as pain, fatigue and adherence. Standard care will follow standard local pathways and will be in line with current English guidelines from the National Institute for Health and Clinical Excellence. Patients will be assessed initially and at 6 and 12 months through self-completed questionnaires and clinical evaluation.DiscussionThe trial will establish whether the known benefits of intensive treatment strategies in active rheumatoid arthritis are also seen in patients with established rheumatoid arthritis who have moderately active disease. It will evaluate both the clinical and cost-effectiveness of intensive treatment.Trial registrationCurrent Controlled Trials, ID: ISRCTN70160382. Registered on 16 January 2014.
Highlights
Uncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time
Analysis of the exploratory extension study will use the final assessment in the TITRATE trial and the new 6-month follow-up data to compare the proportion of patients in remission at 12 and 18 months
Cost utility analysis A cost-utility analysis will be undertaken to estimate the incremental cost per quality-adjusted life year (QALY) of intensive management compared to standard care in Rheumatoid arthritis (RA) patients with intermediate disease activity, alongside the clinical trial
Summary
Aim and hypothesis TITRATE is a robust pragmatic clinical trial to improve outcomes for RA patients with intermediate disease activity by using an Intensive Management Programme. The trial will test the hypothesis that patients with established RA, who currently have intermediate disease activity (defined as DAS28-ESR of 3.2–5.1 with at least three active joints) and are currently receiving at least one DMARD, are more likely to achieve remission at 12 months if they receive intensive management than if they continue to have SC. Target population The target population will be patients attending specialist rheumatology clinics who meet the most recent classification criteria for RA (American College of Rheumatology 2010 criteria); have established RA; currently have intermediate disease activity (DAS28-ESR of 3.2–5.1 and at least three active joints) and are receiving at least one conventional DMARD. Have intermediate disease activity, defined by: (a) DAS28-ESR of 3.2–5.1; (b) at least three active joints (defined as swollen and/or tender) on 66/68 joint count, to include at least one swollen joint
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