Status: Finalised First registered on: 29/05/2020
Last updated on: 20/09/2023
1. Study identification
EU PAS Register NumberEUPAS35384
Official titleA 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 title acronym
Study typeActive surveillance
Brief description of the studyThe 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNot Applicable
2. Research centres and Investigator details
Coordinating study entity
Centre namePfizer, Inc
Centre locationNew York, NY
Details of (Primary) lead investigator
Title Mrs
Last name Binder
First name Elke
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/05/202001/05/2020
Start date of data collection18/05/202023/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report11/10/202311/09/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Barnes
First name David
Address line 166 Hudson Blvd
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States
Phone number (incl. country code)16463068024 
Alternative phone number 
Fax number (incl. country code) 
Email address David.Barnes@pfizer.com
Public Enquiries
Title Mr 
Last name Barnes 
First name David 
Address line 166 Hudson Blvd 
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States 
Phone number (incl. country code)16463068024 
Alternative phone number 
Fax number (incl. country code) 
Email address David.Barnes@pfizer.com 
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