iBaSS

• Research type

  Research Study

• Full title

  IBD Reference and Biosimilar adalimumab CroSS over Study

• IRAS ID

  259061

• Contact name

  Fraser Cummings

• Contact email

  fraser.cummings@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2018-004967-30

• Duration of Study in the UK

  1 years, 11 months, 18 days

• Research summary

  We are proposing to conduct a Phase IV, single-centre, prospective, randomised, single-blind, cross-over study. This study is using both a reference product (Humira-adalimumab) and a Biosimilar product (Imraldi-adalimumab). Biosimilars are biological medicines that were developed to be highly similar to the originator or reference medicines (in this case Humira) in terms of both efficacy (how well it works) and side effects, but offer the potential of lower treatment cost as compared to the originator molecule.

  This study will enrol subjects who are currently being treated with Humira. At the baseline visit subjects will be randomized to either continue on Humira for 24 weeks and then transition to receive Imraldi for a further 24 weeks or transition to Imraldi for 24 weeks and transition back to Humira for a further 24 weeks.

  As far as possible the study will mimic what would happen during a real-world cross over between reference product Humira and biosimilar Imraldi, and vice versa.

  Why? A study of this nature is required because physicians and health authorities are interested in real-world data, on effectiveness, safety and other outcomes, based on subject experience in the routine clinical setting. In particular, in a cost-constrained environment where non-medical transition between biosimilars and originators becomes an increasingly likely scenario, it is important to evaluate the transition process for outcome and safety measures.

  The primary objective is:
  To compare biosimilar Imraldi with Humira as assessed by maintenance of baseline clinical status at both 24 and 48 weeks after initiation of study therapy.

  We will also explore:
  1. To describe subject clinical characteristics and disease status over time
  2. To describe adalimumab and relevant concomitant medication use over time
  3. To evaluate immunogenicity to adalimumab
  4. To describe presence of inflammatory markers over time
  5. To describe subject experience and treatment satisfaction over time

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  19/LO/0167

• Date of REC Opinion

  30 Apr 2019

• REC opinion

  Further Information Favourable Opinion