Here you will find all recent announcements regarding the BSRBR-RA study.
June 2021 - Substantial Amendment 28 (29th March 2021)
The BSRBR-RA recently received approval for the above study amendment.
This amendment covers the following:
- Addition of questions to collect information about COVID-19 (including vaccinations) in participants.
- A brief (optional) addition to extend the studies existing outreach consent process to allow sites to receive signed consent forms back from participants via secure email, where the site has the appropriate security arrangements in place to allow this (local research staff should consult with their R&D departments if they are unsure if they have the appropriate arrangements in place to implement receiving consent forms in this way, or if they should continue to receive consent forms back from participants via post). This change does not affect how sites provide a completed consent form to the BSRBR-RA team, which should still always be uploaded directly to the BSRBR-RA online database.
All amendment documentation (including approvals) can be downloaded here.
June 2021 - BSRBR-RA Newsletter (Summer 2021)
We've recently distributed copies of our Summer 2021 hospital site newsletter to all centres, containing information on outreach consent, upcoming COVID-19 data collection and recent publications. You can download a copy (along with copies of all previous study newsletters) from the 'Newsletters' section of the site.
May 2021 - Now recruiting Ruxience participants!
You can now register patients with RA starting (or switching to) Ruxience (a rituximab biosimilar). Please see our 'registering a new patient' page for further information regarding all cohorts currently open to recruitment along with the eligibility criteria for each cohort.
An updated version of our eligibility checker is also available here.
April 2021 - New paper published: Demyelinating events following initiation of anti-TNFɑ therapy (Taylor et al, 2021)
A new paper based on data from the BSRBR-RA has just been published in the Journal of Neurology, Neuroimmunology and Neuroinflammation.
The full paper can be found at https://nn.neurology.org/content/8/3/e992
A lay summary of the paper can be downloaded directly from our website: BSRBR-RA - Lay Summaries (2021)
April 2021 - Now recruiting Rinvoq & Jyseleca participants!
You can now register patients with RA starting (or switching to) the JAK inhibitors Rinvoq & Jyseleca. The BSRBR-RA received approval to add these drugs to the study as part of substantial amendment 25 on 24/08/2017 (approval letters for all substantial amendments can be found in our online site file).
Please see our 'registering a new patient' page for further information regarding all cohorts currently open to recruitment along with the eligibility criteria for each cohort.
January 2021 - Remsima Subcutaneous (SC) cohort now open!
You can now register patients with RA starting (or switching to) Remsima Subcutaneous (SC). Please see our 'registering a new patient' page for further information regarding all cohorts currently open to recruitment along with the eligibility criteria for each cohort.
March 2020 - COVID-19 Important Announcement
Thank you as always for your support of the BSRBR-RA study. In these difficult times, we want to make sure we are doing everything within our power to help and support our NHS colleagues. Please get in touch if there is anything we can assist you with.
We are aware that outpatient services may be or have already been suspended in many hospitals and non-essential research paused.
Following government advice to limit ‘non-essential’ contact and The University of Manchester’s decision to close non-essential facilities, our team is now remote working and we wanted to share the following important information with you.
1. If you need to contact us: please use email rather than phone and copy firstname.lastname@example.org into your reply in case of staff absence.
2. We have suspended postage of all items to trusts, including reply paid envelopes.
3. Do not post any materials or paperwork back to the University. If you have already sent items, they are being stored securely in the interim and we will process these when we return.
4. The online system for registering a patient and/or submitting follow-up data is still fully operational if you are in a position to do this. We can continue to set up new sites if you currently don’t have access to the online system.
5. As we are classed as a non-CTIMP observational study, changes to how and when participants are seen will not be necessary, however please follow local guidance on this continuing situation. HRA advice is available at https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/
Many thanks again for your support –we will keep you updated with any changes. Stay safe and well.
With best wishes,
The BSRBR-RA Team
September 2019 - BSRBR-RA Web Portal Progress Report
We will be providing regular progress reports on the new BSRBR-RA web portal.
December 2018 - Opening of new cohorts announcement (Amgevita, Hulio, Imraldi & Hyrimoz)
You can now register patients with RA starting or switching to any of the above adalimumab biosimilars. Please see our registration information page for the full list of cohorts currently open to recruitment along with the eligibility criteria for each cohort.
The BSRBR-RA received approvals to add these drugs to the study as part of substantial amendment 20. Approval for this amendment can be found in our online site file documents. Please check with your local R&D department if you are unsure if your trust has approved this amendment prior to recruiting to this or any of our other biosimilar cohorts.
October 2018 - Substantial Amendment 26 ('Views on illness, treatment and general health' booklet re-introduction)
The BSRBR-RA recently received approval to re-introduce the 'Views on illness, treatment and general health' booklet (now version 2, 31/08/18). This booklet was originally introduced back in 2008 as part of substantial amendment 7, and contains a number of validated questionnaires used to measure the influence of adherence in treatment response to biologic and other advanced targeted therapies. This document will be sent out directly to new participants by the study team at the University of Manchester, as part of their weekly direct patient mailings, at baseline, 6 month and 12 month follow up points. Therefore there is no requirement for sites to provide this document to patients. All relevant amendment submission documents (including approvals) can be downloaded here.
May 2018 - New BSRBR-RA Transparency Information Sheet introduced
The BSRBR-RA have introduced a new study document, the Patient Transparency Information Sheet (v1, 18/05/2018). This new document was produced in conjunction with the Health Research Authority (HRA) and The University of Manchester (as the study sponsor) and provides additional clarity for participants regarding how the study complies with the recently introduced General Data Protection Regulation and how we safeguard patient identifiable data. This document should be localised and provided for information to potential participants along with the Patient Information Sheet. The document should also be provided to participants who are currently in follow up when you next see them directly at your site.
February 2018 - Opening of new cohorts announcement
You can now register patients with RA starting or switching to a number of new products including Olumiant (baricitinib), Kevzara (sarilumab), Rixathon (rituximab), Erelzi (etanercept) and Xeljanz (tofacitinib). Please see our registration information page for the full list of cohorts currently open to recruitment along with the eligibility criteria for each cohort.
Participating sites will be contacted directly to announce the opening of these cohorts. This announcement will also include updated copies of our eligibility table, registration checklist, recruitment poster and a new guide to re-registering patients to the study. All documents can also be downloaded directly from this site (new cohort announcement documentation)
The BSRBR-RA received approvals to add these drugs to the study as part of substantial amendment 25 (the JAK inhibitors Olumiant and Xeljanz and the IL6-inhibitor Kevzara) and substantial amendment 20 (biosimilars such as Erelzi and Rixathon). Approvals for both of these amendments can be found in our online site file documents.
October 2017 - Addition of new targeted therapies (including JAK inhibitors) to the BSRBR-RA study
Following the approval of substantial amendment 25 (click here to download all amendment documentation), we have opened recruitment to a new cohort of patients with rheumatoid arthritis who are being treated with the newer advanced targeted therapies, including Janus kinase (JAK) inhibitors.
Recruitment to this new cohort will begin with the Janus kinase (JAK) inhibitor Baricitinib (Olumiant).
Towards the end of the year we hope to be able to open recruitment for other therapies, including Tofacitinib (Xeljanz).
We will continue to notify sites as recruitment expands to include additional treatments as they are licensed for use in the UK. Please see our registration information page for the most up to date list of cohorts currently open to recruitment along with the eligibility criteria for each cohort.
January 2017 – Recruitment has started for biosimilar, Flixabi (Infliximab)
The BSRBR-RA study is now recruiting participants who are being prescribed Flixabi, the Infliximab biosimilar.
Participants can be registered if they have had biologic or biosimilar treatment previously and can be re-registered if they have previously been recruited to BSRBR-RA.
Refer to our Registration information page for further information regarding eligibility for the study.