British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA)

Study identification

• EU PAS number:
  EUPAS35567
• Study ID:
  35568
• Official title and acronym:
  British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA) is a multi‐centre prospective cohort study of persons who meet the CASPAR classification criteria for psoriatic arthritis and:(a) Are starting a biologic disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic DMARD (tsDMARD) that is approved or recommended for the treatment of PsA in the United Kingdom, having never previously received that particular agent, or(b) Have never received a boDMARD, bsDMARD, or tsDMARD agent.These groups comprise the exposed cohort and comparison cohort, respectively, and bDMARDs may include originator or biosimilar products. Standardised questionnaires are completed by the participants, and clinical data is obtained from the rheumatologist and / or the patients’ medical notes.The study evaluates the long-term course of PsA and, patients are followed up annually, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and serious adverse events. In addition, patients starting a bDMARD or tsDMARD (either at recruitment or subsequently) will be followed up three and six months after the commencement of that therapy, with the follow-up schedule being ‘reset’ in the event of switching between therapies. Questionnaire follow-up is tied to patients’ anticipated clinical visit schedule, and clinical centres are contacted regarding any patients lost-to-follow- up. Safety issues, serious adverse events and supplementary information are collected by standardised forms. Once recruited, participants remain eligible for follow-up irrespective of any changes to their therapy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Aberdeen

Study timelines

Date when funding contract was signed

Actual: 05/10/2017

Study start date

Actual: 20/09/2018

Data analysis start date

Planned: 01/08/2020

Date of final study report

Planned: 31/01/2023

Sources of funding

Non-for-profit organisation (e.g. charity)

More details on funding

British Society for Rheumatology

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Website: www.abdn.ac.uk/bsr-psaProtocol registration: www.researchregistry.com (ID: researchregistry3801)