Status: Ongoing
First registered on:
02/07/2020
Last updated on:
26/09/2023
1. Study identification
EU PAS Register NumberEUPAS36129
Official titleAn observational post-authorization safety study to describe the safety of ustekinumab and other treatments of ulcerative colitis in a cohort of patients with ulcerative colitis using the French Nationwide claims database (SNDS) France
Study title acronym
Study typeOther: Study using the French health insurance and hospital discharge database
Brief description of the study
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
Department/Research groupBordeaux PharmacoEpi
Organisation/affiliationUniversity of Bordeaux
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
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
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/04/2020
Start date of data collection31/12/202231/12/2022
Start date of data analysis
Date of interim report, if expected30/11/2025
Date of final study report31/12/2027
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen-Cilag International, NV100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Azzabi
First name Ahlem
Address line 1Lotissement La Colline
Address line 2Immeuble "Les 4 Temps''
Address line 3
CitySidi Maarouf, Casablanca
Postcode20270
CountryMorocco
Phone number (incl. country code)212691522170
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Ahlem
First name Azzabi
Address line 1Lotissement La Colline
Address line 2Immeuble "Les 4 Temps'
Address line 3
CitySidi Maarouf, Casablanca
Postcode20270
CountryMorocco
Phone number (incl. country code)212691522170
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameStelara
CountryFrance
Substance INN(s)USTEKINUMAB
7. Medical conditions to be studied
Medical condition(s)Yes
Colitis ulcerative
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 subjects6667
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
SNIIRAM/SNDS, France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Long term safety profile of ustekinumab for UC, as measured by incidence of malignancies, infections (serious infections, opportunistic infections, and tuberculosis) and VTE.
Primary scope : Long term safety profile of ustekinumab for UC, as measured by incidence of malignancies, infections (serious infections, opportunistic infections, and tuberculosis) and VTE.
12. Main objective(s)
What is the main objective of the study?
The primary study objective is to describe the long-term safety of ustekinumab for UC, as measured by incidence of malignancies, infections (serious infections, serious opportunistic infections and tuberculosis), VTE, MACE and all-cause mortality
The secondary study objective is to compare the long-term safety in patients treated with ustekinumab for UC and patients treated with other therapies
Are there primary outcomes?Yes
Malignancies, infections and VTEs at 3-year and 5-year of follow-up:Incidence rate expressed per 1 000 patient-year in each cohort; Estimation of the cumulative incidence of each outcome in each cohort Comparison of incidence of each study outcome defined above between: ustekinumab and primary comparator, ustekinumab and secondary comparator
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort 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
Analyses will be conducted for each outcome and will include descriptive analyses, comparative analyses, and any relevant sensitivity analyses for each study cohort. Population description, comparative and sensitivity analyses will be performed at 3-year and 5-year follow-up
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
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
