An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103633
• EU PAS number:
  EUPAS103632
• Study ID:
  103633
• Official title and acronym:
  An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Bulgaria

  Croatia

  France

  Greece

  Netherlands

  Poland

  Romania

  Slovenia

  Spain
• Study description:
  Tofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post-approval, active surveillance study of tofacitinib-exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Networks

United Registries for Clinical Assessment and Research (UR-CARE)

Study timelines

Date when funding contract was signed

Planned: 20/11/2020

Actual: 18/11/2020

Study start date

Planned: 31/01/2024

Date of interim report, if expected

Planned: 31/08/2024

Date of final study report

Planned: 31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921352_TOFACITINIB UC PASS PROTOCOL_V4.0_ 27FEB2023

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)