A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in US Patients in the Course of Routine Clinical Care (I5Q-MC-B001)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39914
• EU PAS number:
  EUPAS27597
• Study ID:
  39914
• Official title and acronym:
  A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in US Patients in the Course of Routine Clinical Care (I5Q-MC-B001)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To evaluate the utilisation and long-term safety of galcanezumab in the United States, in routine clinical practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned: 21/01/2019

Actual: 25/01/2019

Study start date

Planned: 31/12/2020

Actual: 21/12/2020

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

I5Q-MC-B001 Protocol v1_Redacted

Updated protocol

I5Q-MC-B001_Galcanezumab_US_LongTermSafety_Protocol_Amend(b)_Redacted

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)