Study identification

PURI

https://redirect.ema.europa.eu/resource/47773

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

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
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

Contact details

Elke Binder

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Study protocol
Initial protocol

A3921405 final approved protocol

English (2.47 MB - PDF)View document
Updated protocol

A3921405 Non Interventional Study Protocol Amendment 1 (clean) V2.0_ 23 September 2021_Redacted

English (3.12 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable