Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant® (baricitinib) a JAK1/2 inhibitor (I4V-MC-B010)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38240
• EU PAS number:
  EUPAS25154
• Study ID:
  38240
• Official title and acronym:
  Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant® (baricitinib) a JAK1/2 inhibitor (I4V-MC-B010)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Sweden

  United Kingdom
• Study description:
  This study will assess: a) Rheumatologists’ understanding of the important safety information detailed in the Healthcare Professional Educational Material, that is, information relating to: ­ Pregnancy and breast feeding ­ Infections ­ Changes in lipid parameters b) Communication of the important safety information and mitigating actions to patients prescribed baricitinib for the first time c) Distribution of the Patient Alert Card (PAC) to patients prescribed baricitinib for the first time.
• Study status:
  Finalised

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 01/01/2019

Actual: 03/12/2018

Study start date

Planned: 31/03/2019

Actual: 19/03/2018

Date of final study report

Planned: 30/09/2020

Actual: 17/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B010 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)