Status: Ongoing First registered on: 30/01/2020
Last updated on: 30/01/2020
1. Study identification
EU PAS Register NumberEUPAS33214
Official titleThe comparative safety of first-line conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) 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 studyWe studied the comparative safety of first-line conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) as prescribed for the treatment of rheumatoid arthritis (RA). Drugs of interest were informed by a parallel drug utilisation study, and included methotrexate, hycroxychloroquine, sulfasalazine, and leflunomide. Study outcomes included cardiovascular disease (myocardial infarction, stroke), infection/s (any, serious, opportunistic), cancer (any, lung, colo-rectal, leukemia, lymphoma) and leukopenia/pancytopenia. Routine (real world) electronic medical records and/or claims data from Germany, Spain, Belgium, France, Netherlands, United Kingdom, Estonia, Japan, and the United States of America were analysed. All subjects aged 18+ , with 1+ year run-in, a diagnosis of RA, and a first-line csDMARD were included at therapy initiation. Propensity score stratification was used to minimise confounding by indication, and negative control outcomes analyses to identify residual (unobserved) confounding.
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 nameCentre for Statistics in Medicine, NDORMS, University of Oxford
Centre locationOxford, United Kinddom
Details of (Primary) lead investigator
Title Professor
Last name Prieto-Alhambra
First name Daniel
Is this study being carried out with the collaboration of a research network?
Yes
EHDEN
OHDSI
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

IDIAPJGol
Erasmus Medical Centre, Rotterdam, the Netherlands
Countries in which this study is being conducted
International study

Belgium
Estonia
France
Germany
Japan
Netherlands
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/11/201801/11/2018
Start date of data collection01/01/200501/01/2005
Start date of data analysis13/01/202013/01/2020
Date of interim report, if expected
Date of final study report31/01/2020
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 schemeIMI2 European Health Data and Evidence Network (EHDEN)100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Prieto-Alhambra
First name Daniel
Address line 1Botnar Research Centre
Address line 2Nuffield Orthopaedic Centre 
Address line 3Windmill Road 
CityOxford 
PostcodeOX3 7LD 
CountryUnited Kingdom
Phone number (incl. country code)00441865223401 
Alternative phone number 
Fax number (incl. country code) 
Email address daniel.prietoalhambra@ndorms.ox.ac.uk
Public Enquiries
Title Professor 
Last name Prieto-Alhambra 
First name Daniel 
Address line 1Botnar Research Centre 
Address line 2Nuffield Orthopaedic Centre 
Address line 3Windmill Road 
CityOxford 
PostcodeOX3 7LD 
CountryUnited Kingdom 
Phone number (incl. country code)00441865223401 
Alternative phone number 
Fax number (incl. country code) 
Email address daniel.prietoalhambra@ndorms.ox.ac.uk 
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