Status: Ongoing First registered on: 02/07/2020
Last updated on: 03/06/2021
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
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 collection31/12/202103/09/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2027
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 Marlies
First name Neuhold
Address line 1Janssen-Cilag GmbH
Address line 2Vorgartenstra├če 26 
Address line 3 
CityWien 
Postcode1020 
CountryAustria
Phone number (incl. country code)436648116482 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Ms 
Last name Marlies 
First name Neuhold 
Address line 1Janssen-Cilag GmbH 
Address line 2Vorgartenstra├če 26 
Address line 3 
CityWien 
Postcode1020 
CountryAustria 
Phone number (incl. country code)436648116482 
Alternative phone number 
Fax number (incl. country code) 
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