Antibody responses to infliximab in patients with IBD
Research type
Research Study
Full title
ANTIBODY RESPONSES TO INFLIXIMAB TREATMENT IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (ULCERATIVE COLITIS AND CROHN’S DISEASE)
IRAS ID
213480
Contact name
Alan Lobo
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of this project is to define the B cell epitopes at the amino acid level associated with the antidrug antibody (ADA) response to the anti-tumour necrosis factor (anti-TNF) agent, infliximab.
The purpose of this proposal is firstly to identify patients who elicit an anti-infliximab immune response and to collect serum and peripheral blood mononuclear cells (PBMC’s) from these patients to be used in studies to
•Identify B cell epitopes associated with the serological ADA response using display technologies
•Recover infliximab specific B cells from which recombinant human monoclonal antibodies associated with ADA immune response will be isolated and characterised.
This will be a longitudinal observational cohort study, with no intervention as part of the research. All patients attending for Infliximab (Remsima) infusions at the Royal Hallamshire Hospital will be invited to participate in the study.
Patients with a diagnosis of ulcerative colitis or Crohns disease will be included. These patients will be receiving or planned to receive treatment with infliximab. Participation in the study will involve consent to taking blood for analysis of the immune response to infliximab at the same time as routine blood taken for their normal clinical care. No additional venepuncture is required.
Patients with high antibody levels may be approached for a further sample of 50 ml for Work Streams 2 and 3.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0379
Date of REC Opinion
14 Sep 2016
REC opinion
Favourable Opinion