DINORA4 22 June 2007

• Research type

  Research Study

• Full title

  A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFá Chimeric Monoclonal Antibody (Infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis

• Contact name

  David Scott

• Sponsor organisation

  Vienna Medical University

• Eudract number

  2006-002787-26

• Research summary

  Purpose of trial: Joint inflammation (arthritis), characterized by swollen and painful joints, can become chronic and continuously painful and may lead to stiffness of the joints and physical disability. This type of arthritis is in an early stage and currently the final diagnosis cannot yet be made. In principle, this illness goes away in approximately half of the patients, although this becomes less likely with increased duration of the disease (in particular with a duration of symptoms of 12 weeks or more). In approximately half of the patients with arthritis which persists more than 12 weeks, the illness stays on a long-term basis. This number is even higher if the arthritis affects the hands for 12 weeks or more; this often leads to the diagnosis of chronic polyarthritis (rheumatoid arthritis). Trial design and duration: This is a double blind placebo controlled trial which is being undertaken and sponsored by the University of Vienna but conducted at King??s College Hospital as the only UK site by Professor Scott. The trial is looking at patients (both male and females) with very early inflammatory arthritis and seeing whether using a biological agent called infliximab in combination with methotrexate works better at treating the disease than methotrexate or conventional treatment alone. The trial will last approximately 106 weeks and patients will be required to have a total of 5 x-rays and 8-weekly infusions. Regular monitoring of trial patients will be done by a dedicated research nurse to ensure that there are no toxicities whilst taking trial medications. An emergency medical contact number for the Principal Investigator will also be provided to patients should they have any concerns or safety issues whilst they are involved in the trial.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/95

• Date of REC Opinion

  9 Mar 2010

• REC opinion

  Further Information Favourable Opinion