Very Early versus Delayed Etanercept in patients with RA (VEDERA)

• Research type

  Research Study

• Full title

  A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA)

• IRAS ID

  67634

• Contact name

  Maya Buch

• Sponsor organisation

  University of Leeds

• Eudract number

  2010-023910-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Patients with early rheumatoid arthritis, who have not yet commenced disease-modifying drugs, will be recruited. In this patient group, current evidence-based guidelines recommend initial treatment with methotrexate and regular monitoring to assess response to treatment. If there are signs of residual disease activity treatment should be increased. Options include adding other medications: tablets such as sulfasalazine and or a TNF inhibitor such as etanercept. The guidelines also advocate the use of TNF inhibitors with methotrexate as initial therapy in patients with severe disease. The purpose of the study is to investigate whether benefits can be gained using a TNF inhibitor very early as supposed to delaying TNF inhibitor therapy until other treatments have failed. Patients will be assigned to one of these two treatment options by chance (like flipping a coin): ?½ Group 1: initial etanercept and methotrexate. ?½ Group 2: initial methotrexate and a treat to target regimen. This involves monitoring of disease activity every month. After 12 weeks, in patients with active disease, tablets will be added which work together with methotrexate (sulfasalazine and hydroxychloroquine). If patients have residual disease activity at 24 weeks, treatment will be changed to etanercept and methotrexate. The study is open label (patients and clinicians will know which study medications patients are receiving). Patient participation lasts for 96 weeks. Our aim is to assess if there is a difference in the number of patients who have no symptoms or signs of arthritis at one year. We will also compare the effect of treatment on: ?½ Joint damage using x-rays, ultrasound, magnetic resonance imaging (MRI). ?½ Bone density using DEXA scans (which uses x-rays). ?½ Disease processes, by looking at changes in the blood and in the lining of joints (the synovium) by taking synovial biopsies. ?½ The cardiovascular system: measuring blood vessel stiffness (applanation tonometry), cardiac MRI and testing blood. This will be undertaken as a substudy.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/138

• Date of REC Opinion

  23 Feb 2011

• REC opinion

  Further Information Favourable Opinion