CAIN457F2366 (EXCEED 1) Secukinumab compared with Adalimumab in PsA

• Research type

  Research Study

• Full title

  A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis

• IRAS ID

  218607

• Contact name

  Hector Chinoy

• Contact email

  Hector.chinoy@manchester.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2015-004477-32

• Clinicaltrials.gov Identifier

  NCT02745080

• Duration of Study in the UK

  2 years, 9 months, 19 days

• Research summary

  Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over active immune system. 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).
  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 overactive immune system. The most commonly used biologic treatments for PsA are drugs which block a particular chemical messenger called TNF alpha, adalimumab is a drug in this class of biologics. Secukinumab is a new class of biologic which blocks the activity of one of the chemical messengers called Interleukin-17A (IL-17A)which is involved in the immune system and is implicated in PsA.
  Secukinumab and adalimumab are both medicines which have been approved and are available for the treatment of people with PsA.
  The purpose of the study is to see if secukinumab is better than and as safe as adalimumab. Patients must not have been treated with a biologic therapy for PsA or psoriasis and have had an intolerance or an inadequate response to standard drugs (cDMARDs).
  Eligible patients will be randomly allocated to one of the 2 treatment groups 1:1 ratio.
  Group 1: Secukinumab 300mg
  Group 2: Adalimumab 40mg

  Participation will last for up to 68 weeks: up to 8 weeks assessing eligibility to take part in the study, 52 weeks of treatment and a safety follow up visit.
  This study is double−blind, which means neither the study doctor nor the patient will know what treatment they are receiving.
  This study will recruit approx.850 patients with 80 patients being recruited in the UK, from 20 hospital sites.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  16/WM/0507

• Date of REC Opinion

  14 Feb 2017

• REC opinion

  Further Information Favourable Opinion