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Contact Information:

Dr Sohail Rahmany
No telephone contact available
sohail.rahmany@uhs.nhs.uk


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Be Part of Research - Trial Details - Investigating the difference between infliximab treatment injected into a vein and injected under the skin in patients with inflammatory bowel disease and inflammatory arthritis already established on infliximab injected into a vein
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Investigating the difference between infliximab treatment injected into a vein and injected under the skin in patients with inflammatory bowel disease and inflammatory arthritis already established on infliximab injected into a vein

Not Recruiting

Open to: All Genders

Age: Adult

0.0 Mile Away
Southampton

Medical Conditions

Ulcerative colitis, crohn's disease, rheumatoid arthritis, psoriatic arthritis, or ankylosis spondylitis

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.


This study is looking at the effects of switching from intravenous (administered into a vein in the hospital) infliximab to infliximab administered subcutaneously (injection under the skin administered at home). The subcutaneous infliximab (commercially known as Remsima) and intravenous infliximab are highly similar.

This study aims to explore the following:
1. Does the clinical status of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis) patients stay the same after switching the route of infliximab administration?
2. How safe and is it to switch from intravenous infliximab to infliximab self-administered subcutaneously?
3. What are the views and experiences of patients who switch from intravenous infliximab to infliximab self-administered subcutaneously?
4. Does the quality of life change for patients switching the route of infliximab administration?

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:

25 Feb 2021 25 Oct 2021

This study aims to follow the normal standard of care as much as possible. Participants will be required to attend up to 4 hospital visits at University Hospital Southampton NHS Foundation Trust (UHS) for trial assessments which will, as far as possible, mirror normal clinical care. These would replace their normal visits for infusions. Participants will be trained on how to self-inject the study drug and will administer this themselves at home every 2 weeks. The study will last for 24 weeks, after which participants will return to their normal clinical care.


Patients aged 18 or over with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis) being treated with intravenous infliximab

You can take part if:



You may not be able to take part if:


1. Allergic to any of the known excipients of infliximab2. Scheduled for a surgical procedure or planned hospitalisation within 6 months of enrolment3. Not anticipated to remain on infliximab for >6 months after enrolment 4. Pregnant or lactating


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

  • University Hospital Southampton NHS Foundation Trust
    Gastroenterology and Hepatology Tremona Road
    Southampton
    SO16 6YD

It is not known if participants will personally benefit from this research, however, it is hoped that this research will show that it is safe and tolerable to switch to the subcutaneous route. One possible benefit is that participants will have fewer visits to the hospital over the time they are in the study.

Most of the treatments and assessments participants will receive will be standard of care (i.e. participants would have received the treatments and assessments anyway even if they weren’t involved in the study). There will be several extra questionnaires to complete as part of the study.

The only additional risk beyond the risks of receiving infliximab via the intravenous route could be discomfort or reactions around the subcutaneous injection site. These can include redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash, and scab on the skin of the injection site. Most of these reactions are mild and resolve relatively quickly on their own.

The most common risks of receiving infliximab via either the subcutaneous or intravenous routes include viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), and injection site-related reactions and pain.

With any infliximab medication, there is a risk of developing an allergic reaction. If a serious reaction occurs, treatment will be given to alleviate the symptoms and further treatment with infliximab will be reviewed. In previous clinical trials, delayed hypersensitivity reactions (unwanted reactions produced by the normal immune system) have been reported so participants will be advised to seek immediate medical advice if they experience any delayed adverse effects.

Dr Sohail Rahmany
No telephone contact available
sohail.rahmany@uhs.nhs.uk



The study is sponsored by University Hospital Southampton NHS Foundation Trust and funded by Celltrion Healthcare.



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What will you do next?
Read full details for Trial ID: ISRCTN13323475

Or CPMS 47620

Last updated 18 January 2022

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

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