Status: Planned First registered on: 19/03/2020
Last updated on: 19/03/2020
1. Study identification
EU PAS Register NumberEUPAS34204
Official titleComparative assessment of venous thromboembolism risk among patients with rheumatoid arthritis treated with baricitinib versus tumor necrosis factor inhibitors - French part of the study program
Study title acronymSafety Outcomes in Patients Treated for RA
Study typeOther: Historical cohort study using the SNDS, the French nationwide claims database
Brief description of the studyRheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease characterized by progressive joint destruction, systemic complications, reduced survival, and a profoundly reduced quality of life among those affected. Baricitinib is a Janus kinase selective inhibitor indicated for treatment of moderate-to-severe RA. Data from clinical trials demonstrate that baricitinib is an effective therapy for RA. During these clinical studies, there was a numerical imbalance in reported venous thromboembolism (VTE) between baricitinib and placebo-treated patients. However, given the limited placebo-treated patients follow-up, it was not possible to support a definitive assessment of the risk of VTE associated with baricitinib treatment, or with other outcomes such as major adverse cardiovascular events (MACE). This cohort study aims to evaluate the risk of VTE, MACE, serious infection, and tuberculosis in a large number of patients treated with baricitinib or tumor necrosis factor inhibitors [TNFi] for RA in France, using the French nationwide claims database (Système National des Données de Santé - SNDS). The cohort will include all patients aged ≥18, treated by baricitinib or TNFi between February 2017 and December 2018. The index date will be defined as the first dispensing of baricitinib or TNFi. Data history will run until January 2015 with a minimum of 180 days prior to index date. Each patient will be followed until 31 December 2018 or until the first of the following events: occurrence of an event of interest, discontinuation of study treatment plus 30 days, health plan disenrollment, or death if identified.
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 belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.bordeauxpharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Thurin
First name Nicolas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/09/2019
Start date of data collection01/06/2020
Start date of data analysis01/10/2020
Date of interim report, if expected
Date of final study report31/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Thurin
First name Nicolas
Address line 1University of Bordeaux
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579209 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Thurin 
First name Nicolas 
Address line 1University of Bordeaux 
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579209 
Alternative phone number 
Fax number (incl. country code)33557574740 
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