Canakinumab single dose pain in Osteoarthritis knee study

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo and Naproxen controlled, multi-center study to determine the safety, tolerability, pharmacokinetics and effect on pain of a single dose intra-articular administration of Cankinumab in patients with osteoarthritis in the knee

• IRAS ID

  44592

• Contact name

  p conaghan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-015017-48

• ISRCTN Number

  Not applicable

• Research summary

  Osteoarthritis (OA) is a chronic degenerative disease involving pain, loss of joint function and disability. The study is being conducted to confirm if Canakinumab is effective in controlling signs and symptoms of OA in the knee. Canakinumab is a drug that mimics a protein which is part of the immune system in all humans known as a fully human monoclonal antibody. It works by decreasing the effect of another protein, interleukin 1 beta. Interleukin 1 beta is expected to be a key protein in causing OA and thus Canakinumab may be effective in controlling the signs and symptoms of OA. The study is divided into 2 parts; Part A and Part B. Part A is being conducted outside of the UK in 16-24 patients and will determine the safe and tolerable dose of Canakinumab to be used in Part B. A total of 135 patients from Germany, Finland, France, Russia, Turkey, USA and UK will be invited to take part in Part B, including approx. 5 patients from a single UK centre. The study design for Part B is a double-dummy, active-controlled, parallel group design. Patients with mild to moderate OA of the knee aged between 40 to 80 years will be invited to take part in this research. Eligible patients will receive a single intra-articular injection to the knee of canakinumab or matching placebo as well as active comparator Naproxen or matching placebo. The study duration following a screening period of up to 3 weeks is 18 weeks including a follow-up visit. Measurements will be made to assess if canakinumab is safe and tolerable. Outcomes will also be measured for OA symptoms of pain, function and stiffness compared to placebo. The comparator arm is being conducted for exploratory purposes.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/27

• Date of REC Opinion

  17 Jun 2010

• REC opinion

  Further Information Favourable Opinion