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TITRATE trial

TITRATE Trial

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Please note that the TITRATE Trial closed for recruitment on 14th July 2017.

 

Title 

TITRATE - Treatment Intensities and Targets in Rheumatoid Arthritis Therapy.

Aim

In the TITRATE Trial, we are studying how best to treat persisting "intermediate" rheumatoid arthritis (RA). We want to know if intensive drug treatment, together with additional support, helps patients more than standard care. 

The goal of the TITRATE trial is to improve outcomes for RA patients with intermediate disease activity by using intensive management to increase remission, reduce disability and enhance quality of life.

Overview

Standard care will involve maintaining suppressive treatment with DMARDs and steroids. Patients will also receive biological treatments if they flare and meet current NICE guidance for using these interventions. In standard care, patients are reviewed at least once each year. Urgent Specialist reviews will be arranged for patients in either treatment arm using routine approaches if there is a clinical need.

Intensive management will involve reviewing patients monthly and immediately adjusting their treatment regime based on changes in their clinical care, by giving DMARD combinations, steroids and, in some patients, biologics, with the aim of achieving remission. 

Primary Objective

The primary objective is to improve outcomes (defined primarily through achieving DAS28-ESR remission at 12 months) for RA patients with intermediate disease activity using intensive management.

Secondary Objectives

The secondary objectives are to reduce disability, enhance quality of life, to show that intensive management is acceptable to RA patients with intermediate disease activity and to determine the cost-effectiveness of intensive management. 

Trial Design

The TITRATE trial is a 12-month, pragmatic, randomised, open-label, two-arm, parallel group, multicentre trial undertaken at specialist rheumatology clinics in England. 

Eligibility

Each patient will be assessed at screening and baseline assessments to ensure that the patient meets the necessary criteria to take part in the TITRATE trial.

Inclusion Criteria
  • Males and females aged over 18 years
  • Have received at least one DMARD for at least six months, and currently receiving at least one DMARD
  • Have intermediate disease activity, defined by: i) DAS28-ESR 3.2-5.1 and ii) at least three active joints (defined as swollen and/or tender) on 66/68 joint count, to include at least one swollen joint
  • Willing and able to follow an intensive management programme
  • Able and willing to give informed consent
Exclusion Criteria
  • Major co-morbidities making intensive treatment inadvisable (e.g. heart failure)
  • Previously failed multiple DMARDs (greater than or equal to five treatments) or having received biologics
  • Irreversible disability from extensive joint damage (for example, replacement of three or more major joints)
  • Women who are pregnant, breast-feeding or at risk of conceiving
  • Current or recent (within the 12 weeks prior to randomisation) participation in another interventional trial
  • Currently in early RA pathway

Trial Oversight

A Trial Steering Committee (TSC) provides oversight of the trial and ensures it is being conducted in accordance of the principles of GCP.

A Data Monitoring and Ethics Committee (DMC) has also been formed to assess the trial's progress, occurrence of adverse events and all other aspects.

Funding

The TITRATE Trial forms part of a programme of work funded by a National Institute for Health Research (NIHR) (UK) Programme Grant for Applied Research (Ref: RP-PG-0610-10066)

If you are interested in recruitment and other trial related news, please see our Twitter page (@titrate_kcl).
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