Secukinumab in rheumatoid arthritis (AINF2302)

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents

• IRAS ID

  63371

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000275-13

• ISRCTN Number

  na

• Research summary

  Rheumatoid Arthritis is a chronic inflammatory disease which leads to cartilage damage and joint destruction. It is generally a progressive disease and its prevalence ranges between 0.5% and 1.0%. Women are affected 2.5 ?? 3 times more frequently than men.Current treatments only partially control the disease and can have adverse effects which limit their use. Treatment is based on suppressing the overactive immune system, but many current treatments only partially control the disease or can have adverse effects which limit their use. Interleukin-1? (IL-17) is a protein of the immune system which is believed to be involved in the inflammation associated with rheumatoid arthritis. Secukinumab is a drug which binds to IL-17A and thereby reduces its activity.The aim of this study is to determine whether Secukinumab is an effective and safe treatment in patients with rheumatoid arthritis, and to see if their disease can be controlled by Secukinumab. Eligible patients who have provided written agreement to take part in the study will attend 30 visits over 104 weeks.This is an international study and it is expected that patients will be enrolled at approximately 150 centers. About 900 patients will be screened for a total of 630 patients to be randomized.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0235

• Date of REC Opinion

  20 Jul 2011

• REC opinion

  Further Information Favourable Opinion