A patient is urging others to take part in research after being involved in a landmark national clinical trial at the James Paget University Hospital.
Ryan Clarke, from Lowestoft, had been suffering from regular bouts of abdominal pain, which became so intense that he called 111 and was advised to attend the Paget’s Emergency Department.
After being admitted to hospital, diagnostic tests revealed that 31-year-old Ryan had Crohn’s Disease, a condition which causes inflammation of the digestive tract leading to symptoms that can have a major impact on quality of life including abdominal pain, diarrhoea, weight loss and fatigue.
The disease results in progressive bowel damage, with one in 20 patients needing urgent abdominal surgery to treat their condition within their first year of diagnosis.
Ryan’s stay in hospital back in September 2021 coincided with the recruitment of Crohn’s patients into a large-scale clinical research trial called PROFILE, which included assessing on the impact of the early introduction of a drug called Infliximab in improving outcomes for patients. The study recruited a total of 386 newly diagnosed Crohn’s patients from 40 hospitals.
Consultant Gastroenterologist, Dr Paul Banim, and the hospital’s clinical research team recruited Ryan and five other patients with newly diagnosed Crohn’s disease into the PROFILE study.
Senior Clinical Research Nurse Helen Sutherland helped to support and coordinate Ryan’s treatment throughout the one year study period.
The trial’s results were published earlier this year, showing that patients randomised to receive Infliximab straight after diagnosis had dramatically improved outcomes compared to those who received the usual standard of care where infliximab is only introduced if the patient fails to respond to other treatments. The improved outcomes included much better symptom control and a ten-fold reduction in the number of people requiring urgent abdominal surgery in the first year following diagnosis.
Ryan was among the participants who received regular intravenous courses of Infliximab, which had an immediate effect on his condition.
“Crohn’s had made my life really difficult. I was anxious every day about how it would affect me and it limited what I could do, to a huge extent.
“Even when was exercising, I would be constantly worried about being ‘caught short,’” said Ryan, who is a teacher at Pakefield High School.
“But after the first course of Infliximab, I could feel my body settling and began to feel better within days. Each course of the drug helped more, to the extent I was able to resume all my usual routines, without discomfort and anxiety.”
After a year of Infliximab treatment, Ryan is now is remission from the disease - and is now living a life ‘incomparable’ to where he was back in 2021.
“If my Crohn’s had continued, it would have turned me into something of a recluse, only wanting to go out locally and for a limited amount of time.
“Now I am able to go to events in London and have booked a holiday abroad later this year.”
Ryan’s message for other people suffering from illnesses like Crohn’s is simple: don’t delay getting checked out by your GP or ringing 111 for advice - and, if there is an opportunity to get involved in clinical research, sign up.
“It was a no-brainer to get involved. There is something really positive in knowing that what you are doing could help not just you but other people, who could receive a treatment that helps them get their lives back as a result.
“At all times during the trial, I felt cared for. I had a point of contact in Helen, who was always available and kept me informed, and knew exactly what was being offered and how I would be monitored,” added Ryan.
The PROFILE trial was sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge and supported by the National Institute for Health and Care Research (NIHR) Clinical Research Network.
It’s remit included testing two different approaches to treating Crohns, including the use of Infliximab, which works by blocking a protein found in the body’s immune system, TNF-alpha, which plays an important role in inflammation. Historically, Infliximab has only been offered to patients who experience regular Crohn’s ‘flare ups’ rather than to those newly-diagnosed with the disease. The results of PROFILE are expected to lead to a change in the care of patients with newly diagnosed Crohn’s, in the UK and worldwide.
Our photograph shows Ryan with Senior Clinical Research Nurse Helen Sutherland.