Monotherapy with INflixIMab when swItching to Subcutaneous thErapy - MINIMISE
Research type
Research Study
Full title
Subcutaneous CT-P13 monotherapy vs combination with immunomodulation when switching from intravenous infliximab in inflammatory bowel disease – A Multicentre, Randomised Withdrawal Trial
IRAS ID
1005499
Contact name
Peter Irving
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Eudract number
2021-006803-13
ISRCTN Number
ISRCTN95420128
Research summary
Infliximab is a well-established treatment for inflammatory bowel disease (IBD). Traditionally infliximab is given to patients as an intravenous infusion, which is an injection directly into a vein. Although treatment with infliximab infusions is effective, patients can develop antibodies against this drug over time. Antibodies are proteins produced by our body when the immune system detects something that could be harmful, such as a virus, bacteria or a chemical. These antibodies can inactivate infliximab, making it less effective and therefore causing flare ups of IBD. To reduce this risk, the infusions are often combined with another drug, a tablet, called an immunomodulator. Unfortunately immunomodulator drugs are not well tolerated by some patients. They can also cause serious side effects, including a small increase in the risk of developing certain cancers. Recently, infliximab became available as a subcutaneous injection. Subcutaneous means that the injection goes under the skin, as opposed to into a vein. This newer form of treatment has been shown to work just as well as the infusions and have the advantage that they can be done at home by patients themselves. Additionally, it is possible that the injections may not need to be combined with the immunomodulator tablets, which could reduce the side effects and risks of treatment. We designed a study to find out if patients need to continue taking immunomodulator tablets when switching from intravenous to subcutaneous infliximab. We plan to enrol 102 patients across 3 NHS hospitals in the UK, who were previously on infliximab infusions and are about to start infliximab injections as part of their routine care. Patients will attend 5 research visits over a period of 6 months, where blood samples will be taken. The study is funded by a company called Celltrion and will be running for 32 months in total.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0166
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion