Characterization and outcomes follow up of patients with rheumatoid arthritis initiating tofacitinib: A retrospective, observational PASS using the British Society of Rheumatology Biologics Register-Rheumatoid Arthritis (BSRBR-RA) A3921448

Study identification

• EU PAS number:
  EUPAS1000000102
• Study ID:
  1000000102
• Official title and acronym:
  Characterization and outcomes follow up of patients with rheumatoid arthritis initiating tofacitinib: A retrospective, observational PASS using the British Society of Rheumatology Biologics Register-Rheumatoid Arthritis (BSRBR-RA) A3921448
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Voluntary, exploratory PASS study to understand baseline characteristics, continuation and efficacy outcomes for adult patients with Rheumatoid Arthritis initiating tofacitinib in the UK. This secondary data study uses data from the existing BSRBR-RA (an ongoing, prospective, observational cohort study started in 2001 with the primary aim of; studying the safety of new therapies for RA during routine post-marketed clinical use) supplied to Pfizer as part of the ongoing commitment PASS study A3921312.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:03/10/2022

Actual:03/10/2022

Study start date

Planned:03/10/2022

Actual:03/10/2022

Data analysis start date

Planned:03/10/2022

Actual:03/10/2022

Date of final study report

Planned:30/09/2024

Actual:25/09/2024

Sources of funding

No external funding

More details on funding

Funded by Pfizer

Regulatory

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