British Society for Rheumatology Biologics Register for Rheumatoid - - PowerPoint PPT Presentation

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Jul 05, 2023 189 likes •430 views

British Society for Rheumatology Biologics Register for Rheumatoid Arthritis UKCRN ID: 7302 Version 1 14/10/2019 Welcome Presentation Primary Aim To monitor the long-term safety of biologic, biosimilar, and other new targeted therapies in

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British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

UKCRN ID: 7302

Version 1 14/10/2019 Welcome Presentation

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Primary Aim

To monitor the long-term safety of biologic, biosimilar, and other new targeted therapies in the UK

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Where is the data used?

Independent Study Open Data Access

Pharmacovigilance

Used for post-marketing surveillance for pharmaceutical companies for the drug regulators (EMA, FDA)

Independent Study

Over 50 scientific academic study papers have been published using BSRBR-RA data View related publications:https://bit.ly/2jWtOle

Open Data Access

External parties are encouraged to access and analyse the rich BSRBR-RA data set Visit the BSR Website to find out more: https://www.rheumatology.org.uk/practice-quality/registers

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Clinical Research Network and Accruals

BSRBR-RA is part of the NIHR Clinical Research Network Portfolio. This means that the study is eligible for consideration for support from the Clinical Research Network in England The coordinating centre at The University of Manchester are responsible for uploading recruitment figures to the Central Portfolio Management system (CPMS) on a monthly basis Further information on this, including a guide on accessing study support, can be found on our website at the following link: https://www.bsrbr.org/hospitals/research-development/clinical-research-network/

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Recruitment Statistics

Up to 31/03/2019 REGISTRATIONS

23300

ACTIVE PARTICIPANTS

301,860

FOLLOW-UPS REQUESTS MAILED TO CENTRES

160

PARTICIPATING NHS ORGANISATIONS

We are proud to be one of the largest prospective studies of patients receiving these drugs in the world. Over 29,000 patients registered in the study since it started in 2001!

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Recruitment Eligibility

Aged 16 Years or over Diagnosis of Rheumatoid Arthritis Starting eligible biologic treatment Registration within 6 months of the therapy start date*

*Patients already registered and starting a new eligible therapy can be re-registered. A cohort switch request needs to be made within 24 months of the new therapy start.

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Drugs we recruit for

ANTI-TNF BIOSIMILARS OTHER TARGETED THERAPIES

HUMIRA (adalimumab orginator)* ENBREL (etanercept orginator)* REMICADE (infliximab orginator)* HULIO (adalimumab)

*patients must be biologic, biosimilar & targeted therapy naïve to be eligible

AMGEVITA (adalimumab) HYRIMOZ (adalimumab) IMRALDI (adalimumab) ERELZI (etanercept) BENEPALI (etanercept) RIXATHON (rituximab) INFLECTRA (infliximab) REMSIMA (infliximab) FLIXABI (infliximab) OLUMIANT (baracitinib) CIMZIA (certolizumab) KEVZARA (sarilumab) XELJANZ (tofacitnib) ROACTEMRA (tocilizumab)

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Information required to register patients

Patient details - including NHS number (CHI number for Scotland) and HRN
DAS28 or disease activity assessment (originator to biosimilar only) - at the time patient

started drug

Tradename of biologic / biosimilar
Start date of biologic (within 6 months of registration)
Completed and initialed current version consent form*

*For further information on the BSRBR-RA consent process visit: https://www.bsrbr.org/hospitals/eligibility/consent-process/

For further information on the BSRBR-RA registration process visit: https://www.bsrbr.org/hospitals/data-collection/registration/

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Baseline Data Capture

Completed upon registration of patients

Clinical Patient

Co-morbidities

Other current therapy Biologic / Targeted Therapy

Disease Activity Patient demographics

EuroQol (EQ5D) Questionnaire Health Assessment Questionnaire (HAQ) Patient Baseline Questionnaire (sent directly to patient from the BSRBR-RA team)

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Follow-up Timeline

Clinical follow up Patient follow up 3 years

6 monthly follow-ups Annual follow-ups

Clinical follow-up data is collected every 6 months for 3 years (FUPs 1-6), then annually thereafter (FUP7+

nwards)

Patient follow-up data is collected every 6 months for 3 years, questionnaires and diaries are sent directly to patients Registration

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Follow-up Data Capture

Biologic Therapy Adverse Events 1) Biologic / targeted therapy Includes any changes to the patient's biologic/biosimilar therapy (start & stop dates, dose, route, and reasons for discontinuation) 2) Other current therapy Includes any changes to the patient's DMARD therapy (start & stop dates and reasons for discontinuation) and any steroids the patient has had during the follow up period 3) Adverse Events Details of any new illnesses or adverse events that have occurred since the last follow up For more information on how to report adverse events: https://www.bsrbr.org/hospitals/data-collection/adverse-events/ 4) Latest DAS28, weight measurement (if available)

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The BSRBR-RA is Online!

Retrieve patient study data Enter data on the BSRBR-RA Database Preview queries Address queries