Inflectra (infliximab) Post-Marketing Observational Study
Research type
Research Study
Full title
Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with Inflectra (infliximab) in Usual Clinical Practice (CONNECT-IBD)
IRAS ID
180533
Contact name
Stuart Bloom
Contact email
Sponsor organisation
Hospira UK Ltd.
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
Remicade (infliximab, Janssen Biotech, Inc.), an IgG1 chimeric human-murine monoclonal antibody (mAb), was authorised for approval in Europe in August 1999. Since then it has been utilised in many thousands of patients for the treatment of 2 major types of inflammatory bowel disease (IBD), Crohn’s Disease (CD) and ulcerative colitis (UC).
In September 2013, Inflectra (infliximab), a mAb biosimilar to reference Remicade, was approved by the European Medicines Agency (EMA) based on an extensive biosimilar comparability exercise, which demonstrated that quality, as well as the clinical efficacy, pharmacokinetics and safety profile of Inflectra are highly comparable to that of Remicade. Marketing authorisation of Inflectra included all approved indications for Remicade including the extrapolated indications of moderate to severe CD and UC.This study is designed to characterise the patient population currently receiving Inflectra in the context of standard of care (SOC) utilisation of Remicade, and to document the safety and effectiveness of Inflectra, also in the context of SOC Remicade, in the treatment of patients with CD or UC in real-world clinical practice.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0316
Date of REC Opinion
28 Aug 2015
REC opinion
Favourable Opinion