3TR Precis-The-RA

• Research type

  Research Study

• Full title

  The 3TR Molecular Pathobiology-Driven Precision Therapy in RA (3TR Precis-The-RA) study

• IRAS ID

  1005441

• Contact name

  Costantino Pitzalis

• Contact email

  c.pitzalis@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Eudract number

  2022-001074-56

• ISRCTN Number

  ISRCTN44988547

• Research summary

  Rheumatoid arthritis (RA) is a chronic inflammatory disease, characterised by persistent synovitis, systemic inflammation and autoantibodies (particularly to rheumatoid factor and citrullinated peptide). In industrialised countries, RA affects 0.5-1% of adults, with 5-50 per 100,000 new cases annually.

  Despite the clinical and radiological benefits of biologic therapies, the vast majority of patients fail to achieve low disease activity or remission. Almost 40% of all patients treated with biologic disease-modifying anti-rheumatic drugs
  (b-DMARDs) do not experience minimally acceptable improvement. Thus, the treatment of RA patients according to their biomarker would provide better care (avert delay starting a more effective drug) and prevent unnecessary exposure to potentially toxic drugs and additionally be cost saving.

  We aim to test whether RNA signatures (biomarkers), in the tissue which surrounds the joints (synovial tissue) from patients with Rheumatoid Arthritis are predictive of response to drug treatments such as biologic disease-modifying
  anti-rheumatic drugs (b-DMARDs).

  Rheumatology patients will undergo a biopsy of their joint, and then will receive either sarilumab or etanercept. Half of patients will receive the drug randomly, and the other half will be treated according to their biomarkers. Patients will attend 4-weekly visits up to 12 weeks, followed by a 30-day safety follow up visit.

• REC name

  HSC REC A

• REC reference

  22/NI/0157

• Date of REC Opinion

  5 Dec 2022

• REC opinion

  Further Information Favourable Opinion