ASTUTE – a new clinical trial starting

We are pleased to tell you about a new clinical trial called ASTUTE which is due to start in England in 2021. BUS has been involved in helping plan this trial.   

ASTUTE will use an adalimumab biosimilar as the study medication. This will be added on to existing standard treatments for non-infectious autoimmune uveitis. Adalimumab biosimilars are newer, highly similar versions of the original adalimumab, Humira. 

The ASTUTE trial will be looking at how effective the study medication is, how well it is tolerated and how cost-effective it is. 

ASTUTE is designed to help doctors find out how the use of an adalimumab biosimilar might improve the treatment of a broad group of non-infectious autoimmune uveitis patients. The trial should also show which patients would benefit the most from adalimumab treatment.

Birdshot patients who do not currently meet the NICE criteria in England for adalimumab treatment may be considered for enrolment in the ASTUTE trial, as well as those who do.

To find out more about ASTUTE and to read the patient information leaflet, go to https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/astute/

Future newsletters will include updates on how the ASTUTE trial is progressing, and we will also let you know which hospital sites have opened for recruitment to the trial. 

July 2021

Birdshot ABC project July 2021

 The Birdshot ABC study is now re-opening at sites after temporarily pausing due to COVID-19. We are very excited to re-open the study and also to implement a brand-new database which has been specifically designed for the study. 

If you have alreadyconsented to the study, the research team that you see may be in touch to re-consent you to the new version of the study documents; this may be via post, telephone or at your next clinic visit. You will be asked to re-consent because there have been some minor changes to the study, and we need to make sure you are happy with the changes. Re-consenting involves reading the new Participant Information Sheet (PIS) and then signing a new updated consent form if you agree to the changes. 

The main changes are: 

Recruitment: Participants can now be sent information about the study in the post and can consent to the study on the telephone

Data collection: The study now collects anonymised eye images as well as data 

Data collection tool: The study now uses a new database provided by an external company called Big Picture Medical. Big Picture are experts in data collection for ophthalmic diseases, and University Hospitals Birmingham, as study sponsor, has a contract in place with them to make sure data is used only for the purposes of the research study. 

If you haven’t yet consented to the study and want to take part, the sites below are currently open for recruitment: 

  • Guy’s and St Thomas’ NHS Foundation Trust – Miles Stanford
  • Manchester University NHS Foundation Trust – Laura Steeples
  • University Hospitals Birmingham NHS foundation Trust – Alastair Denniston
  • Moorfields Eye Hospital NHS Foundation Trust – Narciss Okhravi

The sites below are taking park but are currently still paused to recruitment. However, they should be opening soon:

  • University Hospitals Bristol NHS Foundation Trust – Andrew Dick
  • Leeds Teaching Hospitals NHS Trust – Kanchan Bhan

If you want to take part in the study, please ask at your next hospital appointment or ask for your details to be passed on to the research team, who should then follow up with you.

If your hospital isn’t taking part yet, don’t worry. Our long term vision is to have all UK hospitals that care for birdshot patients signed up to the study. This does, however, take time, so we will keep you updated when new centres come on board.

New BUS factsheet and updated website page

BUS recently added a new factsheet which describes the difference between a biologic drug and a biosimilar.  It has been posted in both our factsheet section and the in the section which gives information about biologic drugs.

Biologics and Biosimilars what’s the difference? Oct 2017

In addition we have also updated our Birdshot research section adding links to a number of recent papers and removing the outdated links.  The new research page can be found at:-

Birdshot research papers