Post Marketing Safety Surveillance of Baricitinib in Three European Registries (I4V-MC-B012)

Study identification

• EU PAS number:
  EUPAS25142
• Study ID:
  25143
• Official title and acronym:
  Post Marketing Safety Surveillance of Baricitinib in Three European Registries (I4V-MC-B012)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Sweden

  United Kingdom
• Study description:
  The objectives of this study are:(1) To monitor the incidence rate and profile of the following aggregate outcomes: serious infections (including herpes zoster) and opportunistic infections (including tuberculosis, Candida infections, and progressive multifocal leukoencephalopathy PML), major adverse cardiovascular events (MACE), malignancies (including lymphoma and typically virus-induced malignancies, such as cervical and many oropharyngeal cancers), and venous thromboembolism (VTE) among patients with long-term exposure to baricitinib compared to patients with long-term exposure to other medications indicated for moderate-to-severe RA, as possible given the data available in the BSRBR, RABBIT and ARTIS registries.(2) To describe the occurrence of the following individual outcomes: lymphoma, herpes zoster, opportunistic infections, rhabdomyolysis, agranulocytosis, PML, gastrointestinal perforations, and evidence of drug-induced liver injury, as possible given the data available in the BSRBR, RABBIT, and ARTIS registries.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Actual:12/05/2017

Study start date

Actual:12/05/2017

Date of final study report

Planned:31/03/2024

Actual:19/03/2024

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)?:
  EU RMP category 3 (required)