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MASTARD-COVID: A Matched-Cohort Study of Treatment-requiring Autoimmune Rheumatic Diseases after COVID-19 Using Japanese Health Insurance Claims Data

MASTARD-COVID: A Matched-Cohort Study of Treatment-requiring Autoimmune Rheumatic Diseases after COVID-19 Using Japanese Health Insurance Claims Data - MASTARD-COVID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060722
Enrollment
580000
Registered
2026-02-21
Start date
2024-04-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease 2019 autoimmune inflammatory rheumatic diseases

Interventions

None listed

Sponsors

The University of Osaka
Lead Sponsor
Data Science Department, Shionogi &amp
Collaborator
Co.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study period spans from January 1, 2020, to August 31, 2022. We identified patients diagnosed with COVID-19, which is categorized under the International Classification of Diseases, Tenth Revision (ICD-10), as U07.1 (COVID-19, virus identified) and U07.2 (COVID-19, virus not identified). These groups form the basis of our exposed cohort. To establish a control group, we selected individuals from the same dataset who were neither diagnosed with COVID-19 nor with B34.2 (unspecified viral infection), matching them with the exposed group based on relevant criteria. The exposed group (COVID-19 patients) includes individuals with a confirmed diagnosis coded either as U07.1 or U07.2 during the data period. Conversely, the control group (non-COVID-19 patients) consists of individuals who were not diagnosed with COVID-19 or B34.2 within the same timeframe. Additionally, the analysis will differentiate between groups based on the timing of COVID-19 infection, providing insights into the impact of infection waves and potentially differing strains of the virus.

Exclusion criteria

Exclusion criteria: Patients with AIIRD (Autoimmune/Inflammatory Rheumatic Diseases) diagnoses within the 6 months preceding COVID-19 infection will be excluded from the evaluation.

Design outcomes

Primary

MeasureTime frame
The primary outcome was defined as the incidence of AIIRD onset within one year during the study period.

Secondary

MeasureTime frame
Secondary outcomes were evaluated as follows: 1. The presence or absence of each outcome associated with hospitalization. 2. Total medical costs incurred after the onset of AIIRD within 12 months following the Index Month (IM) (in yen). 3. The prescription of AIIRD-specific medications. 4. The period from the IM to hospitalization following the onset of AIIRD (in months). The Index Month is defined as the earliest month of COVID-19 diagnosis between July 2019 and August 2023. Additionally, a sensitivity analysis was performed by excluding medications that could potentially be used for COVID-19 treatment (dexamethasone, tocilizumab, sarilumab, baricitinib) from the list of drugs used to determine AIIRD-specific prescriptions. The sensitivity analysis was conducted for the main outcome, which is the frequency distribution, and the exploratory outcome, which is the period from the month of COVID-19 diagnosis to hospitalization after the onset of AIIRD. All of these analyses were conducted as post hoc analyses.

Countries

Japan

Contacts

Public ContactRyuichi Sada

Graduate School of Medicine, The University of Osaka Department of Transformative Analysis for Human Specimen

sadao@cider.osaka-u.ac.jp+81-6-6105-6259

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026