(CAIN457K2340) Secukinumab compared with GP2017 in Active AS

• Research type

  Research Study

• Full title

  A randomized, partially-blinded, active-controlled,multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis

• IRAS ID

  232448

• Contact name

  Dr Raj Sengupta

• Contact email

  rajsengupta@nhs.net

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2017-000679-10

• Duration of Study in the UK

  4 years, 1 months, 0 days

• Research summary

  Research Summary

  Ankylosing spondylitis (AS) is a chronic inflammatory disease involving an overactive immune system. The disease typically causes painful inflammation in the bones and joints of the lower spine and pelvis, but sometimes also more peripheral joints as well. It has a strong genetic link.

  Treatment of the disease aims to reduce pain and inflammation. Recently, biologic drugs have proven successful at treating AS. Biologics are protein based drugs which can target particular elements of the overactive immune system. The most commonly used biologic treatments for AS are drugs which block a particular chemical messenger called TNF alpha.

  Secukinumab as well as a number of anti-TNFs including adalimumab are approved for
  treatment of patients with active AS. Results on signs and symptoms with both secukinumab and adalimumab have demonstrated good response along with rapid reduction of SI-joint and spinal inflammation as evidenced by MRI.

  The purpose of this study is to demonstrate the impact on progression of structural damage in the spine as measured by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) in patients with AS. Data from this study will be used to support the submission of an AS label extension to include a claim on radiographic progression.

  The study is looking to recruit approximately 837 patients worldwide into the study with 45 of these from 15 centres in the UK.

  Summary of Results to be added:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQARiLqHqM-2F1N7VMGQrEDxzNcXK8n4XrjD0JXpFui9CneknI_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJbImrd6ZgTZkZsA0aFYIkMYxkZynMkoLixr2C0UC0U4iKdfFO0pzhW8V91vvRU-2Bj1ngz8Cgj9r6dFKmMVzUf0oyI7HWBVPs0oopGz04x8MNpg1djEjUbQUr2bbYZDWAlv-2F7q7yG4CbfjoMOcWlLPWQ0wSYjcKtS3xbymcOOLYJJw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C873dbd02c5184a23a36808daeef4bdd2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638085032162669256%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=myyH%2BHygyp6bBKXaCQDRWaNeaJXKDLe2w%2FiS0SRNgz0%3D&reserved=0

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  17/SW/0221

• Date of REC Opinion

  16 Nov 2017

• REC opinion

  Further Information Favourable Opinion