Optimising Treatment with TNF Inhibitors in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A “Proof Of Principle” And Exploratory Trial. (OPTTIRA)

• IRAS ID

  53567

• Contact name

  David L Scott

• Eudract number

  2010-020738-24

• ISRCTN Number

  TBC

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Patients with established rheumatoid arthritis (RA) are usually given intensive treatment in the form of tumour necrosis factor inhibitors (TNF-inhibitors) to manage their disease. TNF-inhibitors are currently given at standard doses and at regular intervals, also often with disease modifying anti-rheumatic drugs (DMARDs). The trial investigates whether it is necessary to maintain the standard dose of TNF-inhibitor in patients with well controlled RA and asks the question: Can patients with established RA that have already achieved a good response to TNF-inhibitors have their treatment tapered to a minimum dose without affecting the control of their disease activity?The trial will recruit 99 patients that have been on a stable dose of either etanercept or adalimumab (with at least one DMARD) for at least 6 months. Patients will be randomly assigned two experimental groups, in which their existing treatment will be tapered to either one third or two thirds of their current dose, or a control group. The trial duration will be 12 months. Patients will be assessed at months 0, 3, 6, 9 and 12 using standard validated questionnaires and blood tests as set out in current guidelines for all DMARDs and TNF inhibitors. X-rays will be taken at months 0, 6 and 12. At month 6, patients in the experimental groups will have their TNF-inhibitor dosing further reduced until their medication is stopped completely. Patients in the control group will then also start dose tapering at month 6.Patients will also have the option of participating in a biomarker sub-study which aims to link biological/immunological markers with clinical and imaging data to see if this can be used to predict those subjects most likely to tolerate TNF inhibitor tapering and/or withdrawal. This data will be used to help try and define the optimal combination of markers to predict remission.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/69

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion