TY - JOUR
T1 - Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial)
T2 - Study protocol for a randomised controlled trial
AU - Martin, Naomi H.
AU - Ibrahim, Fowzia
AU - Tom, Brian
AU - Galloway, James
AU - Wailoo, Allan
AU - Tosh, Jonathan
AU - Lempp, Heidi
AU - Prothero, Louise
AU - Georgopoulou, Sofia
AU - Sturt, Jackie
AU - Scott, David L.
AU - Jenner, Richard
AU - Neatrour, Isabel
AU - Baggott, Rhiannon
AU - Kingsley, Gabrielle
AU - Zhong, Yujie
AU - Mian, Aneela
PY - 2017/12/8
Y1 - 2017/12/8
N2 - 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 12months. 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 12months 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.
AB - 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 12months. 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 12months 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.
KW - Intensive treatment
KW - Intermediate disease activity
KW - Randomised controlled trial
KW - Rheumatoid arthritis
KW - Treating to target
KW - Tumour necrosis factor inhibitors
UR - http://www.scopus.com/inward/record.url?scp=85037375794&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-2330-8
DO - 10.1186/s13063-017-2330-8
M3 - Article
AN - SCOPUS:85037375794
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 591
ER -