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
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research groupBordeaux PharmacoEpi
Organisation/affiliationUniversity of Bordeaux
Website/Homepagehttp://www.bordeauxpharmacoepi.eu/
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) 
Email address RA-RNDUS-ClnclTrlsEU@its.jnj.com
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) 
Email address RA-RNDUS-ClnclTrlsEU@its.jnj.com 
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