A Prospective Observational Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults in the United States with Moderate-to-Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B003)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29470
• EU PAS number:
  EUPAS25139
• Study ID:
  29470
• Official title and acronym:
  A Prospective Observational Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults in the United States with Moderate-to-Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B003)
• 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 aggregate serious and opportunistic infections, MACE, malignancies and VTE amongst patients with long-term exposure to baricitinib compared to patients treated long-term with bDMARDs or cDMARDs and to describe the incidence of key individual outcomes. This goal will be achieved through the following specific objectives: The primary objectives are: 1. to compare the incidence rates and profiles of the following aggregate outcomes: serious infections (including herpes zoster) and opportunistic infections (including tuberculosis, Candida infections, and PML), MACE, malignancies (including lymphoma and typically virus-induced malignancies such as cervical and many oropharyngeal cancers), and VTE, among patients with long-term exposure to baricitinib versus patients with long-term exposure to other medications indicated for moderate-to-severe RA. 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 (hypercholestoerolaemia, 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).
• Study status:
  Finalised

Research institutions and networks

Institutions

Corrona Rheumatoid Arthritis Registry

Study timelines

Date when funding contract was signed

Planned: 22/04/2019

Actual: 12/04/2019

Study start date

Planned: 31/12/2018

Actual: 31/07/2018

Data analysis start date

Planned: 22/04/2019

Date of final study report

Planned: 31/12/2031

Actual: 06/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B003 PASS Version 1.0 Nov2018_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)