Here you will find all recent announcements regarding the BSRBR-RA study.
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.