Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information

The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.

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Key information

Conditions

Gout Arthritis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Contact

Cambridge, Massachusetts, 02142, United States

About this study

This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization.

The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database.

All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Index fill date on or after 01 June 2016.
Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision [ICD-9-CM]: 274.x or International Classification of Diseases, tenth revision [ICD-10]: M10.x) at any time in the participant's record.
Continuously enrolled for at least 12 months prior to index fill date.

Treatment and study plan

Primary outcomes

Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users

Time frame: Up to 14 months

Participants will be categorized into new users and prevalent new users. New users are participants who were naïve to allopurinol, defined as no record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat. Prevalent new users are participants who had used allopurinol and switched, defined as at least one record of allopurinol use in all historic pharmacy or medical claims at any time prior to initiation of febuxostat.
Number of Participants With Established Cardiovascular Disease (CVD)

Time frame: Up to 14 months

Participants initiating febuxostat will be categorized as having (Yes/No) to each of the following morbidities at any time prior to initiation of febuxostat: myocardial infarction (MI), unstable angina, stroke (hemorrhagic and ischemic), transient ischemic attack, peripheral vascular disease, diabetes mellitus with evidence of macrovascular or microvascular disease.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Apr 21, 2021
Registry last updated: Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed