Status: Ongoing First registered on: 24/01/2020
Last updated on: 24/01/2020
1. Study identification
EU PAS Register NumberEUPAS33253
Official titleUtilisation disease-modifying anti-rheumatic drugs (DMARDs) used for the treatment of rheumatoid arthritis: protocol for a multi-database real-world cohort study
Study title acronym
Study typeObservational study
Brief description of the studyThere 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 RA ii) utilisation of second line DMARDs during the first year and during the first five years following RA diagnosis iii) proportion of patients not being treated with first line DMARDs following RA diagnosis iv) 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.
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliation
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Professor
Last name Dani
First name Prieto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

IQVIA
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
Countries in which this study is being conducted
International study

Austria
Belgium
Estonia
France
Germany
Japan
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/10/201901/10/2019
Start date of data collection13/01/202013/01/2020
Start date of data analysis15/01/202015/01/2020
Date of interim report, if expected
Date of final study report31/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherOHDSI100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Dani
First name Prieto
Address line 1Gran Via Corts Catalanes, 587
Address line 2àtic 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain
Phone number (incl. country code)0034934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address dprieto@idiapjgol.info
Public Enquiries
Title Professor 
Last name Dani 
First name Prieto 
Address line 1Gran Via Corts Catalanes, 587 
Address line 2àtic 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain 
Phone number (incl. country code)0034934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address dprieto@idiapjgol.info 
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