SWIMSUIT

• Research type

  Research Study

• Full title

  SWitching InflixiMab to SUbcut from Intravenous Therapy

• IRAS ID

  286907

• Contact name

  JR Fraser Cummings

• Contact email

  fraser.cummings@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton NHS Trust

• Eudract number

  2020-004463-25

• Duration of Study in the UK

  1 years, 5 months, 31 days

• Research summary

  This single centre, Phase IV interventional study will be looking at the effects of switching from infliximab administered intravenously to infliximab (CT-P13, a biosimilar of infliximab marketed as Remsima) administered subcutaneously in patients treated as part of thier standard of case and as per license for either Ulcerative Colitis (UC), Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosis Spondylitis (AS).

  Biosimilars are biological medicines that were developed to be highly similar to the originator drug or reference medicines (in this case Remicade) in terms of both efficacy and side effects, however as these are biological molecules it is impossible to make an exact copy.

  The available data on the use if S/C infliximab is in patients who have been started infliximab de novo in phase III clinical studies, rather a population of patients who may have been treated with intravenous infliximab in some cases for many years. Patients will be switched to a self-administered sub cutaneous (SC) injection of CT-P13 every 2 weeks for 24 weeks. A study of this nature is required because physicians and health authorities are interested in real-world data, on effectiveness, safety, tolerability and other outcomes, based on subject experience in the routine clinical setting.

  The study wants to explore a number of things, namely:
  •If the clinical status of UC, CD, RA, PsA and AS patients is maintained after switching
  •How safe it is to switch from an IV infliximab to a self-administered one sub-cutaneous biosimilar drug
  •How tolerable it is to switch from an IV originator drug to a self-administered one sub-cutaneous biosimilar drug
  •Gather information regarding the quality of life of patients before and after switching from IV Infliximab to S/C CT-P13
  •Gather information regarding patient experience after switching from IV Infliximab to S/C CT-P13

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  20/EM/0285

• Date of REC Opinion

  15 Dec 2020

• REC opinion

  Further Information Favourable Opinion