A Longitudinal, Retrospective, Multi-centre Observational Study to Evaluate Effectiveness, Persistence, Treatment Patterns and Safety of Australian Patients Receiving Early Access to Tofacitinib

Study identification

• EU PAS number:
  EUPAS41439
• Study ID:
  47773
• Official title and acronym:
  A Longitudinal, Retrospective, Multi-centre Observational Study to Evaluate Effectiveness, Persistence, Treatment Patterns and Safety of Australian Patients Receiving Early Access to Tofacitinib
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  This study will examine the disease characteristics and outcomes in ulcerative colitis patients granted access to tofacitinib in Australia using deidentified patient information. ; There are over 300 ulcerative colitis patients who have been treated with tofacitinib since its TGA approval. The vast majority of patients who have been granted early access have failed previous biologic therapy. ; There has been limited data presented on the response of patients to tofacitinib after previously failing anti-TNF and anti-integrin therapy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Mater Hospital Brisbane, St Vincent's Hospital Victoria, Austin Health Victoria, St John of God Western Australia, St Vincent's Hospital Victoria, Concord Hospital Sydney, Eastern Health Victoria, Gold Coast Health Queensland, Royal Melbourne Hospital Victoria

Networks

Mater research

Study timelines

Date when funding contract was signed

Planned:31/08/2021

Actual:02/09/2021

Study start date

Planned:30/04/2022

Actual:11/03/2022

Date of final study report

Planned:31/10/2025

Actual:30/09/2025

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