Response to Abatacept with MTX in Active Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  Multicentre, Open-Label study to assess early response to Abatacept with background Methotrexate using Power Doppler Ultrasonography in patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

• IRAS ID

  7356

• Sponsor organisation

  Bristol-Myers Squibb

• Eudract number

  2008-001523-57

• ISRCTN Number

  n/a

• Research summary

  Rheumatoid arthritis (RA) is the most common inflammatory joint disease, affecting approximately 1% of the population worldwide. While RA is recognised clinically because of the severe inflammation affecting the synovial joints, it is also a systemic disease with frequent extra-articular manifestations. The natural history of RA is characterised by joint destruction, impaired physical function, and poor health-related quality of life.Abatacept is an investigational drug under development by Bristol-Myers Squibb. This study is a multi-centre, open-label study to assess early response to Abatacept with background methotrexate using Power Doppler Ultrasound in patients with active rheumatoid arthritis and poor response to methotrexate.The purpose of this study is to evaluate the early (ie. 6 months) effect of abatacept with background methotrexate therapy on the synovial (joint) inflammation of the 2nd-5th finger joints of the hand, by means of a technique called Power Doppler Ultrasonography (PDUS). In addition, other joints involved in rheumatoid arthritis (ie. 1st fingers, wrists, elbows, shoulder, knees, small bones in feet and toes) will be evaluated using the same technique. Ultrasound scanning is a quick, easy and safe technique that uses sound waves to study and treat hard to reach body areas. It provides the ability to study the site of inflammation of the joints (synovitis) as well as measuring bone damage. It is expected that abatacept will have an early effect on synovitis by blocking inflammation and slowing down the joint damage in both hands as assessed by PDUS.Study assessments include: Physical Examinations, Blood/Urine tests, Chest X-ray, PDUS.Patients will receive up to 8 doses of abatacept intravenously over a period of 6 months. A fixed dose (500, 750 or 1000mg) will be determined by body weight.100 patients will be enrolled.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  08/H1306/163

• Date of REC Opinion

  6 Jan 2009

• REC opinion

  Further Information Favourable Opinion