REal Life Safety and effectiveness of tofAcitinib in comparison to TNF InhibitOrs using the French National Healthcare Database (RELATION)

Study identification

• EU PAS number:
  EUPAS41054
• Study ID:
  46290
• Official title and acronym:
  REal Life Safety and effectiveness of tofAcitinib in comparison to TNF InhibitOrs using the French National Healthcare Database (RELATION)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The objectives of this study are mainly to assess tofacitinib safety compared to TNF inhibitors or vedolizumab through French national healthcare database. This study will be performed separately for the rheumatology (RA, and PsA), and for the gastroenterology patients (UC).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Networks

HEVA

Study timelines

Date when funding contract was signed

Planned:01/10/2020

Actual:12/10/2020

Study start date

Planned:31/01/2022

Actual:03/03/2022

Date of final study report

Planned:28/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable