A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic National Health Registries (MK-8259-013)

Study identification

• EU PAS number:
  EUPAS11484
• Study ID:
  50508
• Official title and acronym:
  A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic National Health Registries (MK-8259-013)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Sweden
• Study description:
  Simponi received European marketing authorization for treatment of moderately to severely active ulcerative colitis (UC) on 19-Sep-2013. This registry-based study is being established as a post-marketing commitment to provide additional information on colorectal cancer (CRC), colectomy, and hepatosplenic T-cell lymphoma (HSTCL), as outlined in the Risk Management Plan for SIMPONI® that was approved with authorization of the UC indication.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute of Applied Economics and Health Research (ApHER)

The Institute for Public Health at University of Southern Denmark 1353 Copenhagen, Denmark
Centre for Health Economics at Gothenburg University Vasagatan 1, Gothenburg, Sweden

Study timelines

Date when funding contract was signed

Planned:16/11/2015

Actual:09/12/2015

Study start date

Planned:01/12/2015

Actual:07/02/2017

Data analysis start date

Planned:31/03/2022

Actual:15/02/2022

Date of final study report

Planned:30/09/2023

Actual:26/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD, Janssen

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)