Risk of Safety Events Among Patients with UC and PsA Treated with Tofacitinib and Other Advanced Treatments in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105306
• EU PAS number:
  EUPAS103443
• Study ID:
  105306
• Official title and acronym:
  Risk of Safety Events Among Patients with UC and PsA Treated with Tofacitinib and Other Advanced Treatments in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This non-interventional study aims to provide additional information about incidence rates for specific safety outcomes in ulcerative colitis and psoriatic arthritis populations in routine clinical practice in the United States.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 28/10/2022

Actual: 28/10/2022

Study start date

Planned: 31/03/2023

Actual: 19/04/2023

Data analysis start date

Planned: 31/12/2024

Actual: 18/08/2023

Date of final study report

Planned: 30/11/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921431 Non-Interventional Study Protocol v1.0 (PASS)_22 February 2023_Redacted

Updated protocol

A3921431 Non-Interventional Study Protocol V3.0 18Nov2024.pdf

Regulatory

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