A single-blind, randomized, 3-arm proof of concept study in PMR v1.0

• Research type

  Research Study

• Full title

  A 2-week single-blind, randomized, 3-arm proof of concept study of the effects of AIN457 (anti-IL17 antibody), ACZ885 (canakinumab, anti-IL1b antibody), or corticosteroids in patients with polymyalgia rheumatica, followed by an open label phase to assess safety and long term efficacy.

• IRAS ID

  56255

• Contact name

  Bhaskar Dasgupta

• Sponsor organisation

  Novartis

• Eudract number

  2010-019395-73

• ISRCTN Number

  Not Sent

• Research summary

  Polymyalgia rheumatica (PMR) causes inflammation (mediated by cytokines), pain, stiffness and tenderness in large muscles (upper arms, shoulders and hips). Corticosteroids are the standard treatment and can cause a rapid and often dramatic remission within days. However patients are required to remain on steroids for several years. Around 60% experience relapses during this time and 65% experience at least 1 serious adverse event related to long term steroid exposure. There is therefore a clear unmet need for a steroid-sparing or steroid-alternative therapy for this disease.In this POC study, two biologic agents will be compared alongside corticosteroids to test whether either AIN457 or ACZ885 can reduce the initial signs and symptoms. The study will assess the duration of response, the safety and tolerance of the treatments. The biologic agents on trial are both human monoclonal antibodies.A total of 30 patients aged 50-85 will be treated at 2 UK (both in Essex) 7 USA sites.Patients will be randomised to receive either AIN457, ACZ885 or Prednisone. Patients are blinded to treatment for the first 2 weeks, therefore placebos are required. At first dose patients receive 1 intravenous infusion of either AIN457, ACZ885 or placebo. They will receive a 14 day supply of placebo or Prednisone capsules. Further hospital visits are on days 1, 3, 8 and 15.On day 15 patients will be assessed for a response to treatment. Thereafter the patients enter the open label follow-up with 3 visits each at 2 weeks apart, then 4 visits each at 4 weeks apart ?? the last of these is the completion visit (day 154). If the patient experiences a flare a second infusion may be given (if eligible) and the visit schedule begins again as above.This follow-up phase will continue for 154 days or 112 days after last dose of biologic agent, whichever is greater.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/53

• Date of REC Opinion

  20 Sep 2010

• REC opinion

  Further Information Favourable Opinion