(duplicate) Long term safety study of secukinumab in pts with Psoriati

• Research type

  Research Study

• Full title

  A phase III randomised, double-blind, placebo-controlled multicentre study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with Active Psoriatic Arthritis.

• IRAS ID

  126079

• Contact name

  Hasan Tahir

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-004439-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over-active immune system that develops in at least 5% of patients with the skin condition psoriasis.  The disease can cause painful inflammation in many different joints of the body including the hands, wrists, feet and larger joints as well as the lower spine and pelvis.  It can also cause swelling and pain in fingers (dactylitis) and tendons (enthesitis).  It has a strong genetic link. Treatment of the disease aims to reduce pain and inflammation.  Recently biologic drugs have proven successful at treating PsA.  Biologics are protein based drugs which can target particular elements of the over-active immune system.  The most commonly used biologic treatments for PsA are drugs which block a particular chemical messenger called TNF-alpha. Secukinumab is a new class of biologic which blocks the activity of one of the chemical messages which is involved in the immune system and is implicated in psoriatic arthritis.  This study aims to look at the efficacy, safety and tolerability of secukinumab in patients with PsA over 5 years. Eligible patients will be randomly allocated to receive secukinumab or placebo for up to 24 weeks and thereafter all patients will receive active treatment for 5 years. Neither the patients nor the doctors will know which treatment they receive. PsA will be assessed throughout the five year treatment period, along with a range of safety measures. The study is looking to recruit approximately 400 patients worldwide with 70 of these from 14 sites in the UK. Â

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  13/EM/0095

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion