An evaluation of early use patterns to assess the effectiveness of Xeljanz® (tofacitinib citrate) in rheumatoid arthritis: A retrospective non-interventional database study of observational data embedded within Optimising Patient outcome in Australian RheumatoLogy - Quality Use of Medicines Initiative (OPAL-QUMI) (OPal study of xeljanz Effectiveness in RA - OPERA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27619
• EU PAS number:
  EUPAS18435
• Study ID:
  27619
• Official title and acronym:
  An evaluation of early use patterns to assess the effectiveness of Xeljanz® (tofacitinib citrate) in rheumatoid arthritis: A retrospective non-interventional database study of observational data embedded within Optimising Patient outcome in Australian RheumatoLogy - Quality Use of Medicines Initiative (OPAL-QUMI) (OPal study of xeljanz Effectiveness in RA - OPERA)
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Xeljanz® (tofacitinib citrate) is a potent, selective inhibitor of the Janus kinase (JAK) family of kinases with a high degree of selectivity against other kinases in the human genome. It was approved for use in Australia in Feb 2015 and included in the Pharmaceutical Benefits Scheme (PBS) (reimbursement) in Oct 2015. Limited data exist to describe the characteristics and outcomes in patients who receive Xeljanz® in the real world setting. To permit assessment of general treatment patterns, clinical effectiveness, adherence and patient reported outcomes among RA patients being treated with Xeljanz in the post-approval setting, Pfizer will support a database study utilizing data collected within the Optimising Patient outcome in Australian RheumatoLogy (OPAL) network, a clinician driven point of care observational data management consortium. The OPAL network is made up of Australian private-practice rheumatologists who agree to share a clinical record system for data gathering. Several studies have already been published based on data collected from this combined cohort. This protocol outlines operational and analytical aspects of a database study within the OPAL network to describe treatment patterns and patient characteristics of Xeljanz-treated patients. It will also describe effectiveness of and adherence to Xeljanz in real-world Australian clinical practice. The study will describe baseline characteristics of patients initiating treatment, their clinical and patient-reported outcomes, and any observed safety outcomes. The analyses will be based on enrolled incident users of Xeljanz for RA treatment. Similar data will also be collected for patients treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs) to provide context about clinical management of RA in real-world Australian clinical practice. This study does not aim to perform formal comparisons between Xeljanz and bDMARDs.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 20/04/2016

Actual: 20/04/2016

Study start date

Planned: 19/05/2017

Actual: 09/05/2017

Data analysis start date

Planned: 19/05/2017

Actual: 09/05/2017

Date of interim report, if expected

Planned: 14/07/2017

Date of final study report

Planned: 01/03/2019

Actual: 21/10/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921292 NIS Protocol

Regulatory

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