To compare intensive management with standard care in patients with Rheumatoid Arthritis (RA) with intermediate disease activity.
The National Institute for Health Research (NIHR) is funding a pragmatic randomised controlled trial to compare intensive management with standard care in patients with Rheumatoid Arthritis showing intermediate disease activity (DAS 28-ESR 3.2-5.1). The trial takes place in different hospitals across England and is led by Professor David Scott at King’s College London and King’s College NHS Foundation Trust, London.
The trial has two arms to which patients are randomly allocated: (i) standard care and (ii) intensive management. The first aim of the study is to achieve disappearance of signs and symptoms of RA, e.g. pain, fatigue, mobility, measured by DAS28-ESR (less than 2.6) at 12 months. The secondary aims are to: (i) reduce disability, (ii) improve quality of life and (iii) show that intensive management is acceptable to patients. We will also find out the cost-effectiveness of such an approach compared with standard care.
Patients will be screened first to see if they are eligible for the trial (based on certain criteria),and further assessments will take place at the beginning of the trial, at 6 and 12 months. These include completion of a variety of questionnaires, blood tests and x-rays of hands and feet.
Intensive Management Intervention will involve monthly reviews in the outpatient clinic where patients’ intensive treatment will be (i) reviewed and medication adjusted by a rheumatologist and (ii) supportive non-drug advice and guidance will be provided by nurses to meet each patient’s individual needs. This approach will include goal setting, skills teaching, e.g. management of pain, fatigue and physical activity, based on a specifically developed study manual. The nurses will have undergone a bespoke training to deliver this additional support.
Duration of treatment: 12 months.
Safety: Patients will be regularly monitored via blood tests.
This trial is currently taking place at the following NHS Trusts:
- Ashford and St Peter's NHS Foundation Trust
- Croydon Health Services NHS Trust
- Derby Hospitals NHS Foundation Trust
- East Kent Hospitals University NHS Foundation Trust
- Gateshead Health NHS Foundation Trust
- Great Western Hospitals NHS Foundation Trust
- Guy's & St Thomas' NHS Foundation Trust
- King's College Hospital NHS Foundation Trust
- Lancashire Care NHS Foundation Trust
- Lewisham and Greenwich NHS Trust
- Maidstone and Tunbridge Wells NHS Trust
- Mid Cheshire Hospitals NHS Foundation Trust
- Northampton General Hospital NHS Trust
- Northumbria Healthcare NHS Foundation Trust
- Nottingham University Hospitals NHS Trust
- Plymouth Hospitals NHS Trust
- Portsmouth Hospitals NHS Trust
- RNOH NHS Trust
- Royal Cornwall Hospitals NHS Trust
- Royal Devon & Exeter NHS Foundation Trust
- Sheffield Teaching Hospitals NHS Foundation Trust
- South Devon Healthcare NHS Foundation Trust
- South Tees Hospitals NHS Foundation Trust
- St George's University Hospitals NHS Foundation Trust
- The Dudley Group Group NHS Foundation Trust
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- The Royal Bournemouth & Christchurch NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust
- University Hospitals Coventry and Warwickshire NHS Trust
- West Suffolk NHS Foundation Trust
- Wrightington, Wigan and Leigh NHS Foundation Trust
Please note that the list above may have changed since it was last posted (16 November 2015).
If you need any further information about the TITRATE trial, or are interested in participating, please visit the TITRATE website for the full and most recent list of participating hospitals.
Alternatively, please contact the Trial Manager, Dr Naomi Martin, on 0207 848 5204 or email@example.com.
Please note that you will only be able to participate if the hospital where you are receiving your specialist treatment is involved in the trial.