A Descriptive Retrospective Database Study to Evaluate Serious Clinical Manifestations and Outcomes among SARS-CoV-2 Diagnosed Patients with RA, PsA or UC treated with systemic therapies: A Post Approval Safety Study of Tofacitinib in the Context of the COVID-19 Pandemic

Study identification

• EU PAS number:
  EUPAS35384
• Study ID:
  42208
• Official title and acronym:
  A Descriptive Retrospective Database Study to Evaluate Serious Clinical Manifestations and Outcomes among SARS-CoV-2 Diagnosed Patients with RA, PsA or UC treated with systemic therapies: A Post Approval Safety Study of Tofacitinib in the Context of the COVID-19 Pandemic
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The research questions addressed by this study are: • What proportions of SARS-CoV-2 diagnosed patients have a diagnosis of RA, PsA, or UC (ie, indicated subcohorts) or not (i.e. non-indicated subcohort) and what is risk of serious clinical manifestations and outcomes of interest in these subcohorts? • Within the indicated subcohorts of SARS-CoV-2 diagnosed patients, what is the proportion treated at baseline with the following systemic therapies: tofacitinib, JAK inhibitors, TNFi, non TNFi, and csDMARD and what is risk of serious clinical manifestations and outcomes of interest within strata? This is a retrospective cohort study involving secondary analysis of Optum administrative databases in the US consisting of longitudinal health information about patients tested for or diagnosed with SARS-CoV-2. The data source will be periodically updated and evaluated throughout the course of the study period. The dataset consists of longitudinal data for patients from a subset of healthcare systems that expedite reporting of SARS CoV 2 diagnoses, tests and their results. This dataset has been selected in the study in order to identify early insights into the potential risks of SARS CoV 2 for indicated patients overall and by therapy. This study is an active surveillance study consisting of repeat analyses over multiple time points, beginning with a 30 April 2020 data cut and repeated quarterly (summarized per quarter as well as cumulatively) in order to understand the SARS CoV 2 infected patients over time and across geographies as the virus spreads.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 01/05/2020

Actual: 01/05/2020

Study start date

Planned: 18/05/2020

Actual: 23/05/2020

Date of final study report

Planned: 11/10/2023

Actual: 11/09/2023

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