Study identification

PURI

https://redirect.ema.europa.eu/resource/43731

EU PAS number

EUPAS34204

Study ID

43731

Official title and acronym

Comparative assessment of venous thromboembolism and other risks among patients with rheumatoid arthritis treated with baricitinib versus tumor necrosis factor inhibitors - French part of the study program (Safety Outcomes in Patients Treated for RA)

DARWIN EU® study

No

Study countries

France

Study description

Rheumatoid 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). The baricitinib marketing authorization holder initiated an international study program 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 multiple country data sources. The present study aims to evaluate the safety of patients with RA treated with baricitinib in the French population, using the French nationwide claims database (Système National des Données de Santé - SNDS). The cohort will include all patients aged >18 years with RA, who are included in SNDS and are newly treated by baricitinib or TNFi (absence of use in the 180-day period prior to cohort entry) between September 2017 and December 2019. All patients will have a 2-year database history and will be followed until 31 December 2019 or until the first of the following events: occurrence of an event of interest, discontinuation of study treatment plus 30 days or switch to a medication in another exposure cohort, initiation of a concomitant bDMARD or tsDMARD, health plan disenrollment, or death if identified.

Study status

Ongoing
Research institution and networks

Institutions

University of Bordeaux
France
First published:
01/02/2024
Institution
Educational Institution

Contact details

Nicolas Thurin

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable