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Muscle, Bone and Neurology clinical trial

A PRAGMATIC RANDOMISED CONTROLLED OPEN TRIAL OF THE EFFECT OF INTENSIVE MANAGEMENT (IM) COMPARED WITH STANDARD CARE (SC) ON REMISSION RATES AT 12 MONTHS IN RHEUMATOID ARTHRITIS PATIENTS WITH INTERMEDIATE DISEASE ACTIVITY.

Summary:
TITRATE is a clinical trial designed to improve the specialist management of rheumatoid arthritis. This major health problem affects one adult in a hundred. Its NHS costs exceed £500M/yearly. The main problem in rheumatoid arthritis is inflamed joints. If persistent these cause disability and reduce quality of life.
It is accepted that patients with active early rheumatoid arthritis need intensive management. This type of care results in remission in one third of patients. Such remissions minimise disability and maximise quality of life. However, two thirds of active patients fail to achieve remission. Their on-going grumbling arthritis neither
active nor in remission – means most of them are likely to become very disabled in the fullness of time with current treatment approaches.
TITRATE focuses on these patients. It is designed to find out whether intensive management results in more
remissions in patients with intermediate disease activity. It will also see whether intensive management reduces
disability, enhances quality of life and is acceptable to patients.
The TITRATE trial will enrol 398 intermediate disease activity whose rheumatoid arthritis has lasted 6-120
months.
They will be randomly chosen to receive ‘intensive management’ or ‘standard care’.
‘Intensive management’ will involve monthly sessions with a specialist nurse/health practitioner and a management
algorithm will be used to optimise drug treatment and deliver ‘treatment support’ spanning pain management,
exercise and adherence. Drugs will be used within their licensed indications.
Standard care will involve 6-monthly sessions with specialists in which NICE guidance for managing intermediate disease activity will be followed.
The trial will last 12 months. Patients will be assessed initially and at 6 and 12 months. Self-completed
questionnaires
and clinical evaluation will assess remission, disease activity, disability, quality of life and acceptability.
The potential benefit of intensive management is improved outcomes. Its main limitations are using more drugs,
taking longer and costing more money.

Inclusion criteria:
a) Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria); duration six months to 10 years.
b) Have received at least one DMARD for at least six months, and currently receiving at least one DMARD.
c) Have intermediate disease activity, defined by:
i. DAS28-ESR3.2-5.1.
ii. At least three swollen joints and three tender joints on 66/68 joint count.
d) Willing and able to follow an intensive management programme.
e) Able and willing to give informed consent.

Exclusion criteria:
a) Major co-morbidities making intensive treatment inadvisable (e.g. heart failure)
b) Previously failed multiple DMARDs (≥5 treatments) or having received biologics.
c) Irreversible disability from extensive joint damage (for example, replacement of three or more major joints).
d) Women who are pregnant, breast-feeding
or at risk of conceiving.
e) Currently in early RA pathway.
d) Current or recent (within the previous 12 weeks) participation in another interventional trial.

Principal Investigator for this trial: Dr Ira Pande

Research Ethics Committee Reference: 13/LO/1308

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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