Status: Ongoing First registered on: 17/01/2019
Last updated on: 30/07/2020
1. Study identification
EU PAS Register NumberEUPAS27594
Official titleA Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care
Study title acronymI5Q-MC-B002
Study typeObservational study
Brief description of the studyTo evaluate the utilisation and long-term safety of galcanezumab in Europe, in routine clinical practice.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPHARMO Institute
Department/Research group
Organisation/affiliationThe PHARMO Institute for Drug Outcomes Research
Website/Homepagewww.pharmo.nl
Details of (Primary) lead investigator
Title Dr
Last name Schroeder
First name Krista
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

PHARMO Institute
BIPS GmbH
Bordeaux PharmacoEpi
University of Basel, in collaboration with the Boston Collaborative Drug Surveillance Program, United Kingdom
University Institute for Primary Care Research Jordi Gol and University of Oxford, Spain
Agenzia regionale di sanita della Toscana, Italy
Quantify Research, Sweden
Countries in which this study is being conducted
International study

France
Germany
Italy
Netherlands
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/01/201918/01/2019
Start date of data collection30/06/202030/06/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2026
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schroeder
First name Krista
Address line 1Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States
Phone number (incl. country code)13172763039 
Alternative phone number 
Fax number (incl. country code) 
Email address schroeder_krista_marie@lilly.com
Public Enquiries
Title Dr 
Last name Schroeder 
First name Krista 
Address line 1Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode46285 
CountryUnited States 
Phone number (incl. country code)13172763039 
Alternative phone number 
Fax number (incl. country code) 
Email address schroeder_krista_marie@lilly.com 
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