Study identification

PURI

https://redirect.ema.europa.eu/resource/32272

EU PAS number

EUPAS32271

Study ID

32272

Official title and acronym

Comparative Assessment of VTE and Other Risks among Patients with Rheumatoid Arthritis treated with Baricitinib versus Tumor Necrosis Factor Inhibitors: A Multi-database Observational Cohort Study

DARWIN EU® study

No

Study countries

France
Sweden
United Kingdom
United States

Study description

This study aims to evaluate the safety of patients with RA treated with baricitinib. This aim will be achieved using postmarketing data from multiple sources and through the following objectives, to be addressed by a meta-analysis of analytic results across individual data sources: Primary Objective: To compare the risk of VTE among patients with RA treated with baricitinib with the risk among similar patients treated with TNFi. Secondary Objectives: • To compare the risk of MACE among patients with RA treated with baricitinib with the risk among similar patients treated with TNFi. • To compare the risk of incident serious infection among patients with RA treated with baricitinib with the risk among similar patients treated with TNFi. • To describe the risk of tuberculosis (TB) requiring hospitalization among patients with RA treated with baricitinib.

Study status

Finalised
Research institution and networks

Institutions

Aetion
Spain
First published:
16/07/2024
Institution
OtherENCePP partner
Eli Lilly and Company

Contact details

Claudia Salinas

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Study protocol
Initial protocol

B023 05 Protocol(d)

English (856.46 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable