Secukinumab versus placebo in psoriatic arthritis

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis

• IRAS ID

  81037

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000276-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an overactive immune system that develops in at least 5% of patients with the skin condition psoriasis. The disease causes painful inflammation in many joints of the body (hands, wrists, feet, lower spine and pelvis) and can also cause swelling and pain in fingers (dactylitis) and tendons (enthesitis). It has a strong genetic link. Treatment aims to reduce pain and inflammation. 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 block a chemical messenger called TNF-alpha. Secukinumab is a new class of biologic; it is an antibody directed against another immune system chemical messagenger called interleukin 17. This study aims to look at the efficacy and safety of secukinumab in patients over a 2 year period in patients with psoriatic arthritis. Eligible patients will be randomly allocated to receive secukinumab or placebo ("dummy" drug) for 2 years. The study will be blinded, so neither the doctors nor the patients will know which treatment is being administered. Patients who are initially in the placebo group will be re-assigned to receive active secukinumab at either week 16 or week 24, depending on their assessment results at week 16. This study is split into 3 stages - screening period, treatment period and follow up period. Each participant will be in the study for a maximum of 116 weeks, and will be on study treatment for up to 100 weeks. Patients will have their PsA assessed regularly throughout the study, along with a range of safety measures.Approximately 600 patients will be recruited into the study worldwide. Approximately 25 of these will be from the UK, recruited across 5 centres.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0219

• Date of REC Opinion

  23 Aug 2011

• REC opinion

  Further Information Favourable Opinion