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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Naomi H. Martin, Fowzia Ibrahim, Brian Tom, James Galloway, Allan Wailoo, Jonathan Tosh, Heidi Lempp, Louise Prothero, Sofia Georgopoulou, Jackie Sturt, David L. Scott, On behalf of TITRATE Programme Investigators

Published in: Trials | Issue 1/2017

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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.
Appendix
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Metadata
Title
Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial
Authors
Naomi H. Martin
Fowzia Ibrahim
Brian Tom
James Galloway
Allan Wailoo
Jonathan Tosh
Heidi Lempp
Louise Prothero
Sofia Georgopoulou
Jackie Sturt
David L. Scott
On behalf of TITRATE Programme Investigators
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2330-8

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