ANSWERS

• Research type

  Research Study

• Full title

  An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly

• IRAS ID

  56082

• Contact name

  Karl Gaffney

• Sponsor organisation

  Norfolk & Norwich University Hospitals NHS Foundation Trust

• Eudract number

  2010-020913-10

• Research summary

  Ankylosing spondylitis (AS) is a chronic, inflammatory joint disease characterised by spinal inflammation and progressive spinal fusion. This leads to significant disability and reduced quality of life. Whilst the causes of AS are not clearly understood, the presence of elevated levels of Tumour Necrosis Factor (TNF) in sacroiliac joints suggests the disease is triggered by a prolonged immune response to infection. Treatment options for AS have been limited, comprising physical therapy plus disease modifying anti-rheumatic drugs and anti-inflammatory medicines to combat joint pain and morning stiffness. However, a number of TNF inhibitors have now been developed and three therapies (Adalimumab, Infliximab and Etanercept) are licensed in the United Kingdom to treat patients with active AS for whom conventional treatment has failed. Etanercept has a well defined and acceptable safety profile and is effective in reducing pain and stiffness and improving functional outcome. A dosage of 50mg per week is effective for approximately two thirds of AS patients with benefits manifesting within 3 months of initiating treatment. This study investigates whether a treatment response is maintained in AS patients when the dose of Etanercept is reduced by 50% after 6 months of therapy. The study design comprises an open label, two centre, randomised controlled trial. Participants will be initiated on Etanercept 50 mg once weekly. After a 6 month lead-in phase, responders to Etanercept (as defined by NICE criteria) will be randomly assigned to either step down to 25mg dose or continue with 50mg. Both groups of patients will be followed up for 6 months post step-down. Participants will be evaluated at screening, baseline and months 3, 6, 9 and 12. Patients randomised to 25 mg who subsequently loose response will be offered to increase to the usual 50mg maintenance treatment. Assessments will include measurements of efficacy and adverse effects.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/52

• Date of REC Opinion

  6 Aug 2010

• REC opinion

  Favourable Opinion