Recruitment - 11.12.2014 [11/12/2014]

275 patients have been recruited to the study.

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TACERA is a longitudinal, observational study in early Rheumatoid Arthritis taking place at approximately 30 sites in England and Scotland. The study is investigating the prediction of clinical responses to therapy and defining remission at both clinical and molecular levels. It is run under the direction of Chief Investigator, Professor Andy Cope in the Academic Department of Rheumatology at King’s College London and supported by the King’s Clinical Trials Unit, a UKCRC registered unit. The study is sponsored by King’s College London and Guy's and St Thomas' NHS Foundation Trust and has been funded through the MRC/ABPI Inflammation and Immunology Initiative now known as the RA-MAP Consortium.

Study Summary

Patients newly diagnosed with Rheumatoid Arthritis are treated conventionally according to NICE guidelines. There is no cure for Rheumatoid Arthritis (RA); instead, the goal is to achieve low disease activity and ultimately disease remission. However a blanket approach to giving treatment exists as it is not currently possible to predict which drug (or drugs) will produce a favourable response in a particular patient and it is currently difficult to identify patients in clinical remission. This study aims to define predictors of clinical response and define what true remission is in patients with early RA. The plan is to use this information to develop an ‘immunological toolkit’ to help predict which patients will respond well to particular treatments so that patients can be treated with individualised drug combinations that are most likely to induce and sustain remission.

The study will recruit 410 patients within 4 weeks of diagnosis. They will not have received disease modifying anti-rheumatic drugs (DMARDs) or corticosteroid treatment for the current episode of inflammatory arthritis. In addition all subjects will be positive for Rheumatoid Factor and anti-citrullinated protein antibody (ACPA). Patients will receive standard treatment following national guidelines throughout the study period.

The study duration will be 18 months. Patients will be assessed at months 0, 3, 6, 9, 12, 15 and 18 using standard validated questionnaires and blood tests as set out in current guidelines for all DMARDs and TNF inhibitors.

Biological sampling (blood and urine) will be carried out at each assessment for the purpose of developing an ‘immunological toolkit’. X-rays will be taken at 0, 12 and 18 months.

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