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

Study identification

• 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

Regulatory

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