Non-Interventional Study to Review the Changes of Depression after First-Year of Tofacitinib Treatment in Rheumatoid Arthritis (XELJANZ®)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48626
• EU PAS number:
  EUPAS40263
• Study ID:
  48626
• Official title and acronym:
  Non-Interventional Study to Review the Changes of Depression after First-Year of Tofacitinib Treatment in Rheumatoid Arthritis (XELJANZ®)
• DARWIN EU® study:
  No
• Study countries:
  Czechia
• Study description:
  This study is to describe and evaluate the changes of depression level within 12 months from the start of Tofacitinib therapy in patients with Rheumatoid arthritis
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

MEDICAL PLUS, s.r.o. Uherské Hradiště, Revmatologická ambulance Ostrava, Thomayerova nemocnice Prague, Revmatologický ústav Prague, RHEUMA s.r.o. Břeclav, BORMED, spol. s r.o. Ostrava-Třebovice, Revmatologie s.r.o. Brno, Value Outcomes s.r.o

Study timelines

Date when funding contract was signed

Planned: 01/09/2019

Actual: 19/09/2019

Study start date

Planned: 01/06/2020

Actual: 23/07/2020

Data analysis start date

Planned: 29/02/2024

Actual: 07/02/2024

Date of final study report

Planned: 07/01/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921330 Final Protocol 02 April 2019

Updated protocol

A3921330 Non Interventional Study Protocol_Amendment 1 V2_clean_18Jun2021 (2)

Regulatory

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