iBiSS v1.0
Research type
Research Study
Full title
IBD Biosimilar to Biosimilar Infliximab Switching Study
IRAS ID
244677
Contact name
Fraser Cummings
Contact email
Sponsor organisation
University Southampton Hospital NHS Foundation Trust
Eudract number
2018-001546-33
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
This study will be looking at the effects of switching from one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease.
We will be enrolling patients who are currently on a drug known as CT-P13 (Inflectra, Remsima), which is referred to as a Biosimilar drug. A biosimilar drug means it is very or highly similar to the brand (originator) product but made in a slightly different way. This leads to tiny differences, but should not affect how the drug works, or it’s safety and side effects. Participants will be switched from CT-P13 to another Biosimilar drug, known as SB2 (Flixabi).
Infliximab is sometimes known by the brand name Remicade and is considered the originator or reference drug.
CTP-13 (Inflectra, Remsima) and SB2 (Flixabi) are ‘biosimilars’ of Remicade, but work in the same way.
This study wants to explore a number of things, namely;
•How UC or CD is maintained after switching
•How safe it is to switch from one Biosimilar drug to another
•How the immune system responds to this change
•Gather information regarding the quality of life after switching from CT-P13 to SB2.
•Gather information regarding the patient experiences of switching from CT-P13 to SB2.
Currently there have been no comparisons made in terms of efficacy and outcomes between biosimilars and this study hopes to provide this informationREC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0254
Date of REC Opinion
11 Jul 2018
REC opinion
Further Information Favourable Opinion