Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46622
• EU PAS number:
  EUPAS45035
• Study ID:
  46622
• Official title and acronym:
  Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To perform a retrospective matched cohort study to compare clinical outcomes of these agents among anti-TNF exposed patients with Ulcerative Colitis in our health system.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Networks

Mass General Brigham (MGB)

Study timelines

Date when funding contract was signed

Planned: 29/10/2021

Actual: 06/12/2021

Study start date

Planned: 01/03/2022

Actual: 24/02/2022

Date of final study report

Planned: 30/03/2023

Actual: 13/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921415 Non Interventional Study Protocol Final 08Feb2022_Redacted

Updated protocol

A3921415 Non Interventional Study Protocol Amendment 1 (clean) 08Apr2022 (1)_Redacted

Regulatory

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