Study identification

PURI

https://redirect.ema.europa.eu/resource/33254

EU PAS number

EUPAS33253

Study ID

33254

Official title and acronym

Utilisation disease-modifying anti-rheumatic drugs (DMARDs) used for the treatment of rheumatoid arthritis: protocol for a multi-database real-world cohort study

DARWIN EU® study

No

Study countries

Austria
Belgium
Estonia
France
Germany
Japan
Spain
United Kingdom
United States

Study description

There are no studies to date that have compared international drug utilisation of rheumatoid arthritis patients receiving DMARDs and long-term sequential prescribing following initial prescription. A drug utilisation study (DUS) on the use of DMARDs would therefore provide insights into real-world practice in RA.By means of a retrospective cohort study using routine-collected health care data which has been mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), we aim to characterise the prescribing/dispensing of first line DMARDs with regard to: i) type of first DMARD being prescribed during the the first year and during the first five years following the diagnosis of RAii) utilisation of second line DMARDs during the first year and during the first five years following RA diagnosisiii) proportion of patients not being treated with first line DMARDs following RA diagnosisiv) characterize use of DMARDs over calendar time.The start date for the study period will be from 01/01/2000 or from the start of the first available observation periods in the data source with sufficient data whichever comes last. The study period will end at the latest on 31/12/2018 for all data sources. The study population consists of DMARD naive rheumatoid arthritis (RA) patients. Patients are required to be ≥ 18 years at index and have ≥ 365 days of prior continuous observation and 365 days post-index time. DMARD drug exposure (biologic DMARD, tsDMARD, or csDMARD) will be identified from the drug exposure table in the CDM. Study participants demographics (gender, age, observation time prior to their index date, and their index year and month) will be idenfied.Both the incidence and prevalence of RA will be calculated as well as the proportion of patients treated with DMARDs. A sunburst diagram will be produced to describe the proportion of DMARD treatments for each treatment sequence observed in the target population.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner
University of Manchester
United Kingdom
First published:
01/02/2024
InstitutionEducational Institution
Erasmus MC Rotterdam, The Netherlands, NDORMS, University of Oxford Oxford, UK, IEETA/DETI, University of Aveiro Aveiro, Portugal, Centre for Epidemiology Versus Arthritis, University of Manchester Manchester, UK, Janssen Research and Development Titusville, USA, Columbia University, New York New York, USA

Contact details

Prieto Dani

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

OHDSI
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable