An 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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/45589
• EU PAS number:
  EUPAS36129
• Study ID:
  45589
• Official title and acronym:
  An 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
• DARWIN EU® study:
  No
• Study countries:
  France
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 14/04/2020

Study start date

Planned: 31/12/2022

Actual: 31/12/2022

Date of interim report, if expected

Planned: 30/11/2025

Date of final study report

Planned: 31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag International, NV

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)