ASUS - Abatacept in Seronegative Undifferentiated arthritis Study

• Research type

  Research Study

• Full title

  Single-centre, Pilot Study Assessing the Efficacy of Abatacept in Anti-CCP Negative Undifferentiated Inflammatory Arthritis

• IRAS ID

  6308

• Contact name

  Maya H Buch

• Eudract number

  2008-004878-41

• ISRCTN Number

  n/a

• Research summary

  The purpose of the study is to investigate Abatacept, a drug that is already licensed for treating patients with rheumatoid arthritis. Abatacept is a protein that has been designed to block the stimulation of a group of cells called T-cells that are involved early on in the inflammatory pathway linked to rheumatoid arthritis. It is given as an infusion every 4 weeks.A recent study that Abatacept can prevent progression of an early, inflammatory arthritis to an established rheumatoid arthritis in patients who have an antibody associated with rheumatoid arthritis. This study is being carried out to see if Abatacept has a similar effect in patients who also have an early inflammatory arthritis but who do not have the antibody. The primary aim of this study is to assess how many patients achieve remission i.e. no evidence of arthritis and no more damage to joints. The study is now fully recruited with follow-up ongoing.Twenty patients who had at least 2 involved joints (confirmed with ultrasound scan) and who did not have the antibody (tested with a blood sample) have been recruited. We will perform regular blood tests to check on the safety of the drug and on any changes in activity of disease that may have resulted from Abatacept use are being performed. Patients will receive drug for 12 months but followed up for another 12 months without study drug. All patients will receive the active drug i.e. there will be NO placebo (dummy drug). The results will be fully analysed once all 20 patients have completed the study.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/33

• Date of REC Opinion

  29 Jul 2009

• REC opinion

  Further Information Favourable Opinion