An Active Surveillance, Post-Authorization Study to Assess Tofacitinib Utilization Patterns and to Characterize the Safety of Tofacitinib Use in Patients with Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data from a US Administrative Healthcare Claims Database

Study identification

• EU PAS number:
  EUPAS36041
• Study ID:
  46136
• Official title and acronym:
  An Active Surveillance, Post-Authorization Study to Assess Tofacitinib Utilization Patterns and to Characterize the Safety of Tofacitinib Use in Patients with Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data from a US Administrative Healthcare Claims Database
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The goal of the study is to understand the patterns of tofacitinib use in the US and to characterize the safety of tofacitinib (all approved formulations) in ulcerative colitis (UC) patients in the post-approval setting. The primary outcome of interest is malignancy, excluding non-melanoma skin (NMSC).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual: 25/10/2019

Study start date

Planned: 30/06/2020

Actual: 30/06/2020

Data analysis start date

Planned: 30/06/2025

Date of final study report

Planned: 30/05/2026

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)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

A3921347