Status: Finalised
First registered on:
06/06/2014
Last updated on:
12/07/2018
1. Study identification
EU PAS Register NumberEUPAS6736
Official titleEuropean Drug Usage Survey for Amyvid (I6E-MC-AVBF)
Study title acronymI6E-MC-AVBF
Study typeObservational study
Brief description of the studyThis is a survey of physicians who refer patients for Amyvid PET scans. This study seeks to establish the usage patterns of Amyvid in European 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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Details of (Primary) lead investigator
Title Dr
Last name Salinas
First name Claudia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/12/201415/12/2014
Start date of data collection15/12/201417/12/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report01/06/201728/10/2017
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 Salinas
First name Claudia
Address line 1Eli Lilly and Company, Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode
CountryUnited States
Phone number (incl. country code)13174339188
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Salinas
First name Claudia
Address line 1Eli Lilly and Company, Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode
CountryUnited States
Phone number (incl. country code)13174339188
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)V09AX05 (florbetapir (18F))
7. Medical conditions to be studied
Medical condition(s)Yes
Dementia Alzheimer's type
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects100
Additional information
At least 100 patient reports from at least 30 physicians will be required, with no more than 5 patient reports from each physician.
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To assess the usage patterns of Amyvid in European clinical practice;
To assess the level of off-label use in European clinical practice.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Reasons for the Amyvid referral will be summarized using responses to the survey questions. The level of off-label use will be reported for each relevant question as a proportion of the total responses and as the total number of questions consistent with off-label use. Results will also be analysed by temporal period (1, 2, or 3 years elapsed since commercial launch of Amyvid) to evaluate if there are trends in patterns of Amyvid use. Reasons for non-response will be evaluated to assess the potential existence of selection bias. Additional information is available in the report.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
