Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Peter Irving
+44 (0)20 7 188 2486
peter.irving@gstt.nhs.uk


Dr Peter Irving
+44 (0)20 7 188 2486
peter.irving@gstt.nhs.uk


Ms Alima Rahman
+44 20 7188 7188 56688
alima.rahman@gstt.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Investigating the need to continue taking immunomodulator tablets for patients with inflammatory bowel disease, when switching from treatment with intravenous infliximab infusions (infliximab given directly into a vein) to subcutaneous infliximab (infliximab given by an injection under the skin).
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Investigating the need to continue taking immunomodulator tablets for patients with inflammatory bowel disease, when switching from treatment with intravenous infliximab infusions (infliximab given directly into a vein) to subcutaneous infliximab (infliximab given by an injection under the skin).

Not Recruiting

Open to: All Genders

Age: Adult

London London

Medical Conditions

Crohn's disease and ulcerative colitis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 causing IBD flare-ups. 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 has 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

19 Oct 2022 17 Oct 2024

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 will be running for 32 months in total.


Adults with IBD, such as Crohn's disease and ulcerative colitis

You can take part if:



You may not be able to take part if:


1. Not willing or able to switch to subcutaneous (SC) treatment 2. Evidence of clinically active severe infections such as, bacterial sepsis, active viral infection and opportunistic infections. Severity as judged by the investigator3. Any clinically significant test results that in the opinion of the investigator should exclude the participant4. In the opinion of the investigator, patient in whom withdrawal of the thiopurine would not be appropriate 5. Known allergy/ hypersensitivity/ intolerance to the active substance or excipients, or patients taking any medications which are contraindicated as per the IMPs SmPCs6. Participation in an investigational trial that involves ongoing treatment with an investigational medicinal product at baseline7. Pregnant women and women of child bearing potential who are planning to get pregnant during the trial


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guys Hospital
    Great Maze Pond
    London
    SE1 9RT
  • University College Hospital
    235 Euston Rd
    London
    NW1 2BU

Participating in this trial may not have any direct benefits. We hope that this trial will provide information that will help us to improve the care of patients with IBD in the future.
The risk of stopping immunomodulator tablets is a risk of increased disease activity. Participants will be assessed for signs and symptoms of worsening disease activity at each study visit (by means of physical examination and HBI/SCCAI indexes). Blood tests will be performed which will be reviewed for evidence of worsening inflammation (CRP and calprotectin measurements).
For participants randomised to continuing immunomodulators, the risks of side effects from the medication are no different from before (participants would have been on combination therapy for at least 22 weeks prior to randomisation).
For all participants, there may be bruising and discomfort at the site of the blood tests, as with any blood test. Where possible, the blood taken for research purposes will be collected at the same time as your routine blood tests to minimise discomfort.

Dr Peter Irving
+44 (0)20 7 188 2486
peter.irving@gstt.nhs.uk


Ms Alima Rahman
+44 20 7188 7188 56688
alima.rahman@gstt.nhs.uk


Dr Peter Irving
+44 (0)20 7 188 2486
peter.irving@gstt.nhs.uk



The study is sponsored by Kings Health Partners and funded by Celltrion Healthcare.



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Read full details for Trial ID: ISRCTN95420128

Or CPMS 53185

Last updated 22 October 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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