[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”BADBIR” _builder_version=”3.17.6″]<\/p>\n
Start date: 2007<\/p>\n
Number of registrations: Over 19,500 registrations from 164 centres<\/p>\n
BADBIR is a long-term prospective observational cohort study monitoring the safety and efficacy of biologic therapy in people with severe psoriasis.<\/p>\n
Visit the BADBIR website<\/a><\/p>\n <\/p>\n [\/et_pb_text][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_divider _builder_version=”3.17.6″]<\/p>\n [\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”BILAG LEFT” _builder_version=”3.17.6″]<\/p>\n Chief Investigator: Professor Ian Bruce<\/a><\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”BILAG RIGHT” _builder_version=”3.17.6″]<\/p>\n Start date: 2010<\/p>\n Number of registrations: Over 1,300 from 59 centres<\/p>\n BILAG-BR is a national study looking at the long-term safety and efficacy of biologic therapy in patients with lupus, compared with a group receiving standard immunosuppressive therapy.<\/p>\n Visit the BILAG-BR website<\/a><\/p>\n <\/p>\n [\/et_pb_text][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_divider _builder_version=”3.17.6″]<\/p>\n [\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”BSRBRRA LEFT” _builder_version=”3.17.6″]<\/p>\n Chief Investigator: Professor Kimme Hyrich<\/a><\/p>\n<\/div>\n<\/div>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”BSRBRRA RIGHT” _builder_version=”3.17.6″]<\/p>\n Start date: 2001<\/p>\n Number of registrations: Over 30,000 from more than 160 hospitals<\/p>\n BSRBR-RA is our flagship study. It is the largest study of its kind in the world and has a high research output. It is a UK national study and is supported by a team of 17 staff.<\/p>\n Visit the BSRBR-RA website<\/a><\/p>\n<\/div>\n<\/div>\n <\/p>\n [\/et_pb_text][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_divider _builder_version=”3.17.6″]<\/p>\n [\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”CAPS LEFT” _builder_version=”3.17.6″]<\/p>\n Chief Investigator: Professor Wendy Thomson<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”CAPS RIGHT” _builder_version=”3.17.6″]<\/p>\n Start date: 2001<\/p>\n Number of registrations: Over 1,700 from 7 centres<\/p>\n CAPS recruits children who are newly diagnosed with juvenile idiopathic arthritis. It aims to discover ways to predict how patients will manage over the long term.<\/p>\n Visit the CAPS website<\/a><\/p>\n <\/p>\n [\/et_pb_text][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_divider _builder_version=”3.17.6″]<\/p>\n [\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”JIA LEFT” _builder_version=”3.17.6″]<\/p>\n Chief Investigator: Professor Kimme Hyrich<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”JIA RIGHT” _builder_version=”3.17.6″]<\/p>\n Start date: BSPAR ETN \u2013 2004, BCRD – 2010<\/p>\n Number of registrations: Over 3,400<\/p>\n Two studies called Biologics for Children with Rheumatic Diseases (BCRD) and BSPAR Etanercept Study (BSPAR ETN) are underway at hospitals throughout the UK to look at the safety and effectiveness of biologic, biosimilar and other new treatments for Juvenile Idiopathic Arthritis (JIA). As part of the studies, long term follow-up information regarding changes to the disease and any newer illnesses is collected to determine the safety and effectiveness of these types of treatments.<\/p>\n Planning for a future without fear: Studying the long-term health of people with JIA.<\/strong><\/p>\n Dr Lianne Kearsley Fleet is a researcher at The University of Manchester. For the past 11 years, Lianne has been researching important questions for children and young people with juvenile idiopathic arthritis. She has recently been awarded a Versus Arthritis Career Development Fellowship to investigate what happens to children and young people with JIA as they transition to adulthood.<\/p>\n Visit the JIA Studies website: BCRD\/BSPAR<\/a><\/p>\n <\/p>\n <\/p>\n [\/et_pb_text][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_image src=”https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-content\/uploads\/sites\/233\/2020\/02\/banner4.png” _builder_version=”3.17.6″]<\/p>\n [\/et_pb_image][et_pb_text _builder_version=”3.17.6″]<\/p>\n \n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Our Funding LHS” _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Our Funding LHS” _builder_version=”3.17.6″]<\/p>\n Our funding model helps maintain academic independence while we carry out the administration of our projects.<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Our Funding RHS” _builder_version=”3.17.6″]<\/p>\n Most of our studies are funded through both contracts with charitable organisations and a separate contract for financial support with the pharmaceutical industry.<\/p>\n BCRD and CAPS are wholly charity-funded.<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Space” _builder_version=”3.17.6″]<\/p>\n \n <\/p>\n [\/et_pb_text][et_pb_divider _builder_version=”3.17.6″]<\/p>\n [\/et_pb_divider][et_pb_text _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Services LHS” _builder_version=”3.17.6″]<\/p>\n We are open to collaboration with the pharmaceutical industry and academic units. This is subject to relevant approvals from the study funders and scientific steering committees. <\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”SERVICES RHS” _builder_version=”3.17.6″]<\/p>\n \nSee below for more information on the data we collect from our studies and what we can provide. Please get in touch to discuss potential collaborations with us.<\/p>\n [\/et_pb_text][et_pb_button button_url=”mailto:kath.watson@manchester.ac.uk” button_text=”Email us now ” _builder_version=”3.17.6″]<\/p>\n [\/et_pb_button][et_pb_accordion _builder_version=”3.17.6″][et_pb_accordion_item title=”Reports for the pharmaceutical industry” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n Depending on the specific contract, participating pharmaceutical companies are provided with fully anonymised safety surveillance reports, including the following.<\/p>\n These report a serious adverse event (SAE) from the study to the appropriate company.<\/p>\n These ensure all SAE reports have been received by the company.<\/p>\n These contain anonymised data and corresponding coding schedules.<\/p>\n These are sent to industry every six months using the Manchester Template agreed with the European Rheumatology Biologic Registers Group and industry representatives in 2002. It is reviewed regularly to ensure that rates can be compared effectively.<\/p>\n Each report is divided into three sections:<\/p>\n Access to comparison cohort data is also available. <\/strong><\/p>\n To find out more about these services, please contact Dr Kath Watson (kath.watson@manchester.ac.uk<\/a>).<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Other available analyses” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n We offer regulatory analyses on an ad hoc basis, via pharmaceutical companies who are obligated to respond to such queries from the European Medicines Agency, US Food and Drug Administration, and Medicines and Healthcare products Regulatory Agency, at a cost per analysis.<\/p>\n Academic analysis of data collected by the studies within the BSG is ongoing. Publications from the flagship BSRBR-RA study are available to view and download on the BSRBR-RA website<\/a>.<\/p>\n We can also provide access to a dataset for analysis purposes.<\/p>\n To find out more about these services, please contact Dr Kath Watson (kath.watson@manchester.ac.uk<\/a>).<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”How we collect and process study data” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n We collect and process detailed safety data for all participants. A comprehensive pharmacovigilance standard operating procedure is in place to document this process, which is reviewed with industry on an annual basis.<\/p>\n We use patient questionnaires, clinical case notes and linkage with national databases such as NHS Digital to collect data. Detailed adverse event and serious adverse event (SAE) data is reviewed by the pharmacovigilance team, who code the events using the Medical Dictionary for Regulatory Activities (MedDRA) and look for any safety signals.<\/p>\n SAEs are reported to industry as required. Reports are sent to a Data Monitoring Committee. Analyses are undertaken to compare rates of SAEs, and findings are conveyed to the clinical community via published journal articles.<\/p>\n [\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Space” _builder_version=”3.17.6″]<\/p>\n \n <\/p>\n [\/et_pb_text][et_pb_image src=”https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-content\/uploads\/sites\/233\/2020\/02\/tech.png” _builder_version=”3.17.6″]<\/p>\n [\/et_pb_image][et_pb_text admin_label=”Space” _builder_version=”3.17.6″]<\/p>\n \n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Contacts LHS” _builder_version=”3.17.6″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Contacts LHS” _builder_version=”3.17.6″]<\/p>\n If you wish to collaborate or apply for access to a dataset, please get in touch.<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Contacts RHS” _builder_version=”3.17.6″]<\/p>\n Dr Kath Watson [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Connect Title” custom_padding=”0px||0px|” _builder_version=”3.0.90″ background_color=”#1d1d1d” module_class=”footer-section” prev_background_color=”#ffffff” global_module=”380″][et_pb_row admin_label=”row” global_parent=”380″ locked=”off” allow_player_pause=”off” parallax=”off” parallax_method=”on” parallax_1=”off” parallax_method_1=”off” parallax_2=”off” parallax_method_2=”off” parallax_3=”off” parallax_method_3=”off” make_fullwidth=”off” use_custom_width=”off” width_unit=”on” use_custom_gutter=”off” make_equal=”off” module_id=”footer-row” _builder_version=”3.0.89″][et_pb_column type=”1_3″][et_pb_text admin_label=”Contact Us Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n [\/et_pb_text][et_pb_text admin_label=”Contact Us” global_parent=”380″ text_text_color=”#aaaaaa” parent_locked=”off” background_layout=”light” text_orientation=”left” use_border_color=”off” border_color=”#ffffff” border_style=”solid” module_class=”contact-us” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n +44 (0) 161 306 6000<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″][et_pb_text admin_label=”Find Us Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n [\/et_pb_text][et_pb_text admin_label=”Address” global_parent=”380″ background_layout=”dark” text_orientation=”left” use_border_color=”off” border_color=”#ffffff” border_style=”solid” module_id=”address” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n The University of Manchester [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″][et_pb_text admin_label=”Connect Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n [\/et_pb_text][et_pb_code admin_label=”Social Media” global_parent=”380″ parent_locked=”off” _builder_version=”3.17.6″]<\/p>\n <\/p>\n <\/p>\n <\/p>\n <\/ul>\n [\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Studying the safety and efficacy of biologic, biosimilar and other targeted therapies in musculoskeletal and dermatological conditions. We have developed and coordinated national prospective observational cohort studies in the UK for over 20 years. Biologic Studies Group (BSG) is based at the Centre for Musculoskeletal Research at The University of Manchester. We primarily […]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-1423","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/pages\/1423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/comments?post=1423"}],"version-history":[{"count":129,"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/pages\/1423\/revisions"}],"predecessor-version":[{"id":1687,"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/pages\/1423\/revisions\/1687"}],"wp:attachment":[{"href":"https:\/\/sites.manchester.ac.uk\/biologic-studies-group\/wp-json\/wp\/v2\/media?parent=1423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}British Isles Lupus Assessment Group Biologics Register (BILAG-BR)<\/h3>\n
British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA)<\/h3>\n
Childhood Arthritis Prospective Study (CAPS)<\/h3>\n
Juvenile Idiopathic Arthritis (JIA) Studies<\/h3>\n
UK JIA Biologics Register<\/h4>\n
BCRD and BSPAR ETN<\/h5>\n
Adults with JIA<\/h5>\n
Our funding<\/h2>\n
Our services<\/h2>\n
Standard ’24-hour’ serious adverse event reports<\/h4>\n
Monthly reconciliation lists<\/h4>\n
Annual datasets<\/h4>\n
Comprehensive six-monthly reports<\/h4>\n
\n
Ad hoc analyses as requested by regulators<\/h4>\n
Academic analyses<\/h4>\n
Contact us<\/h2>\n
Programme Manager
Email: kath.watson@manchester.ac.uk<\/a><\/p>\nContact Us<\/h4>\n
Find Us<\/h4>\n
Oxford Rd
Manchester
M13 9PL
UK<\/a><\/p>\nConnect With Us<\/h4>\n
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