Being involved in the study
The BILAG BR has been reviewed and approved by a research ethics committee, and is overseen by Ian Bruce, a highly experienced consultant rheumatologist who is also a Professor of Rheumatology at The University of Manchester.
What’s involved in being part of the BILAG BR?
We’ll follow your progress through your hospital care team, who will collect data on your lupus symptoms and treatment when you attend your routine hospital appointments.
With your consent, we will collect urine samples from you, as well as extra blood samples at the same time as your usual blood tests, so you will not need to have any extra trips to the hospital.
We will also ask you to fill in some questionnaires about your lupus symptoms and how they affect your life.
We will send you the same questionnaires at regular intervals throughout the study; initially three and six months after your treatment, and then annually.
You will also be asked to keep a diary of changes in medication, hospital stays and appointments.
We would like to collect this information for at least five years, but longer if possible.
Why get involved?
By participating in the study, you will be contributing towards the amount of data available for researchers to look at the safety and effectiveness of biologic treatments for lupus.
If you are not involved in the study but would like to be, please speak with your hospital care team to see if you are eligible to join.
Participants are “flagged” with national healthcare data providers
With their consent, all participants are “flagged” with national healthcare data providers, such as NHS Digital, for participants in England and Wales, and The National Health Service Central Register (NHSCR) for participants in Scotland, who will then inform us if any of the participants on our studies develop a serious illness such as cancer, or if they pass away.
What does being “flagged” mean?
National healthcare data providers, such as NHS Digital or NHSCR have information about the health of everyone in the country, and they store details about any hospital stays or serious illnesses that people experience.
When you consent to be involved in the BILAG BR study you give agreement for your name, date of birth and NHS number (or CHI number if you are in Scotland) to be shared with these national healthcare data providers (including NHS Digital and NHSCR).
This is for the purpose of matching identifiable information already held by these national databases so that they are able to “flag” you.
This flag means that if you experience a really serious illness, such as cancer, then the research study will be informed of these events directly by the national databases.
This is a resource that is really important for research into health and diseases such as SLE, as the information that we get from NHS Digital and other national databases is added to the information that we collect from your healthcare team.
This makes our data more complete, stronger and more reliable.