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)
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)
6. Study drug(s) information
Substance class (ATC Code)L04AA29 (tofacitinib)
7. Medical conditions to be studied
Medical condition(s)Yes
Rheumatoid arthritis
Colitis ulcerative
Psoriatic arthropathy
Additional Medical Condition(s)
Not Applicable
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects1385530
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
