Rheumatologist and Dermatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant (baricitinib), a JAK1/2 inhibitor (I4V-MC-B025)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43240
• EU PAS number:
  EUPAS43239
• Study ID:
  43240
• Official title and acronym:
  Rheumatologist and Dermatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant (baricitinib), a JAK1/2 inhibitor (I4V-MC-B025)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  This study will assess: a) effectiveness of the updated baricitinib healthcare professional (HCP) educational materials and Patient Alert Card among dermatologists and rheumatologists and b) the effectiveness of a Direct Healthcare Professional Communication (DHPC) distributed to dermatologists and rheumatologists. This study was updated as a result of the Article 20 referral for JAKi, the protocol was endorsed by PRAC.
• Study status:
  Ongoing

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 15/09/2021

Study start date

Planned: 31/03/2024

Actual: 27/03/2024

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Updated protocol

LY3009104 B025(b) NI PASS Protocol_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)