A PROPER research outcome for the rheumatology team | Latest news

The COVID-19 pandemic has meant that across the world, vital clinical research has been slowed down or stopped completely. For some patients, clinical trials offer the only treatment option or access to life-saving medications. With this in mind, the Rheumatology Research Team based at QMC worked even harder to enable patients to take part in the observation of a current standard of care treatment. 

The Europe-wide study was investigating the “real world” experiences of patients who have been switched from the current standard treatment to another adalimumab biosimilar drug. 

The Nottingham team was asked to recruit 40 patients, which included those with a range of inflammatory conditions such as axial spondyloarthritis, psoriatic arthritis and Crohn’s disease. 

By the end of May they had recruited 29 patients in less than two months. So successful has their approach been that the team plans to carry on offering patients the opportunity to take part.

“This study definitely is an exemplar of how team working and lateral thinking has made us proud. It is a feather in the cap for NUH R&I,” said Dr Ira Pande, Consultant Rheumatologist and Principal Investigator (PI) for PROPER study (looking at the “Real World” Experience of a Biosimilar Drug).

Team members who worked on PROPER at NUH were Marie-Josèphe Pradère and Paige Draper, as well as PI Dr Pande and sub-investigator Dr Megan Rutter.

The strong relationships established by the research nurses with their patients as well as the team’s levels of knowledge and skills in adapting the study to take account of the COVID-19 lockdown, are all part of the Nottingham success story.

When the study sponsor approached the Nottingham team to ask them to enrol patients in the PROPER study, they were interested in involving patients with the inflammatory conditions ankylosing spondylitis and psoriatic arthritis, as well as patients for Crohn’s disease, a gastrointestinal condition for which the drug is also indicated.

Discussions with the sponsor started in December and NUH went live as a fourth UK trial site, joining other sites that opened around the same time in Belfast and Surrey.

“We were aware that recruitment was competitive, and patients were switching drugs, so time was crucial – so we had to act fast,” said Dr Pande.

“While local capacity and capacity checks were underway between site and sponsor to set up the study, I got the team to create a log of potential patients as they attended clinic for routine care. The aim was to jump start once we got the go-ahead and recruit top heavy.”

But just weeks after NUH was cleared to recruit for PROPER, the government declared lockdown due to the Coronavirus pandemic, which lead to a large number of trials being paused in Nottingham and elsewhere. 

Dr Pande said their preparations “coincided with the pandemic that was out of our control and something no one could have planned for. The majority of this patient population was shielding and almost all of them had switched to the biosimilar. At one point, as PI, I thought it was now a non-starter…”

However, the study had already received ethics approval earlier in the year for an amendment to include postal contact with patients based on feedback from sites set up in July 2019. After gaining permission from the study sponsor and R&D to use telephone and postal questionnaires for other key protocol requirements such as disease score and adverse events instead of physical visits to see research staff in clinic, the research team used lockdown to their advantage.

“The timing was perfect, as a lot of patients who are normally busy and would be out at work were at home,” explained research nurse Marie-Josèphe Pradère.

“Some were finding things difficult as they had been required to home school their kids. After working for many years as a research nurse I have learned to do things differently when required, so I called them in the evenings rather than the daytime with the questionnaires.”

Paige Draper (pictured) adapted the survey, so it was suitable for use over the phone and the research nurses tapped into the willingness to participate in studies among their patients.

“A lot of the success has been down to adapting things to the circumstances as we go along,” added Marie-Josèphe. “Some study protocols allow for postal consent to participate in research in exceptional circumstances so other teams may find it worth asking their study’s chief investigator if a postal study is possible (instead of face-to-face appointments).”

Biosimilars are administered by patients themselves using a special injection device. Patients with ankylosing spondylitis are often men diagnosed under the age of 35 while those with psoriatic arthritis come from a wider age range, ranging from their teens and beyond