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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?

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

11. Scope of the study

What is the scope of the study?

Safety surveillance

Primary scope : Safety surveillance

12. Main objective(s)

What is the main objective of the study?

What proportions of SARS-CoV-2 diagnosed patients have RA, PsA, or UC or not and what is risk of serious clinical manifestations & outcomes of interest in these subcohorts? What is the proportion treated at baseline with the following systemic therapies: tofacitinib, JAK inhibitors, TNFi, non TNFi, and csDMARD & what is risk of serious clinical manifestations and outcomes by treatment strata?

Are there primary outcomes?Yes

Determine the proportions of patients with a diagnosis of RA, PsA, & UC; describe baseline demographic characteristics, treatment history and comorbidities; estimate proportion experiencing serious clinical manifestations and outcomes of interest; determine the proportions of patients treated with the following systemic therapies at baseline: tofacitinib, JAK inhibitors, TNFi, non-TNFi & csDMARD.

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Cohort study

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

After selection of the study population, summary statistics of baseline variables will be determined for the baseline period. The index date for each patient is defined as the first date that the study inclusion criteria are satisfied. Baseline variables will be summarized as appropriate for categorical and continuous variables with 95% CI provided to show precision of the estimate. Among patients who are included in the study, outcomes will be included that occur during the risk window from index date until the first of death (based on discharge status), 3 months post SARS CoV 2 diagnosis, or end of study period/datacut. The endpoints of interest within each indication, non indicated subcohort and indication/treatment combination will be summarized as appropriate for categorical and continuous variables with 95% CI provided to show precision of the estimate.