A Retrospective Cohort Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults with Moderate to Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B004)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30229
• EU PAS number:
  EUPAS25145
• Study ID:
  30229
• Official title and acronym:
  A Retrospective Cohort Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults with Moderate to Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B004)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  *Note, this study was terminated, and the attached final abbreviated report contains descriptive information up until time of termination. The goal of this study is to monitor the incidence and nature of key serious infections, MACE, VTE, and malignancies amongst patients exposed long term to baricitinib compared to patients treated long-term with bDMARDs or cDMARDs. This goal will be achieved through the following specific objectives: 1) To assess and compare the risk 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 similar patients with RA 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 PML, rhabdomyolysis, myelosuppression (agranulocytosis), hyperlipidaemia (hypercholesterolaemia, hypertriglyceridaemia), gastrointestinal perforations, and evidence of drug-induced liver injury. A secondary objective is to describe the incidence of the above outcomes in very elderly patients (aged ≥75 years old).
• Study status:
  Finalised

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned: 31/03/2019

Actual: 25/03/2019

Study start date

Planned: 30/06/2023

Actual: 14/10/2019

Date of interim report, if expected

Planned: 31/03/2027

Date of final study report

Planned: 30/06/2030

Actual: 19/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B004 Pass Version 1.0 Dec2018_Redacted

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)