Study identification

PURI

https://redirect.ema.europa.eu/resource/42324

EU PAS number

EUPAS25151

Study ID

42324

Official title and acronym

A Retrospective Cohort Study to Assess the Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Rheumatoid Arthritis in Nordic Countries (I4V-MC-B011)

DARWIN EU® study

No

Study countries

Denmark
Finland
Norway
Sweden

Study description

This study aims to evaluate the safety of baricitinib among (A) rheumatoid arthritis (RA) and (B) atopic dermatitis patients treated in routine clinical care. Primary objectives: (1) to compare the incidence rates and profiles of: serious infections overall (including herpes zoster) and opportunistic infections (including tuberculosis, Candida infections, and progressive multifocal leukoencephalopathy), major adverse cardiovascular events, malignancies overall (including lymphoma and typically virus induced malignancies such as cervical and many oropharyngeal cancers), and venous thromboembolism, among patients with long term exposure to baricitinib compared to similar patients with long term exposure to other indicated medications, (2) to describe the incidence rates of the following individual outcomes: lymphoma, herpes zoster, opportunistic infections such as tuberculosis, Candida, and progressive multifocal leukoencephalopathy, rhabdomyolysis, agranulocytosis, hyperlipidaemia (hypercholesterolaemia, hypertriglyceridaemia) - RA only, gastrointestinal perforations, and liver injury. Secondary objectives: (3) to monitor the incidence rates of the aggregate outcomes of serious infections overall, MACE, malignancies overall, and VTE in very elderly patients, that is, those ≥75 years of age, (4) to assess the effectiveness of risk minimisation activities by describing the pattern of use of baricitinib and the occurrence of pregnancy, active tuberculosis or active viral hepatitis, and monitoring and treatment of lipid levels in relation to such use in routine clinical care.

Study status

Ongoing
Research institution and networks

Institutions

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:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company Corporate Center
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)