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Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial

Martin, N. H., Ibrahim, F., Tom, B., Galloway, J., Wailoo, A., Tosh, J., Lempp, H., Prothero, L. ORCID: 0000-0002-5385-0397, Georgopoulou, S., Sturt, J., Scott, D. L. and TITRATE Programme Investigators, . (2017). Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial. Trials, 18, 591.. doi: 10.1186/s13063-017-2330-8

Abstract

Background
Uncontrolled 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.

Methods
The 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.

Discussion
The 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 registration
Current Controlled Trials, ID: ISRCTN70160382. Registered on 16 January 2014.

Publication Type: Article
Additional Information: Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Publisher Keywords: Rheumatoid arthritis, Intermediate disease activity, Treating to target, Intensive treatment, Randomised controlled trial, Tumour necrosis factor inhibitors
Departments: School of Health Sciences > Optometry & Visual Science
Date available in CRO: 04 May 2021 13:45
Date deposited: 4 May 2021
Date of acceptance: 16 November 2017
Date of first online publication: 8 December 2017
URI: https://openaccess.city.ac.uk/id/eprint/25989
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