Real world evidence of the usage of tofacitinib in Ulcerative Colitis patients in Lebanon

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48631
• EU PAS number:
  EUPAS38515
• Study ID:
  48631
• Official title and acronym:
  Real world evidence of the usage of tofacitinib in Ulcerative Colitis patients in Lebanon
• DARWIN EU® study:
  No
• Study countries:
  Lebanon
• Study description:
  A retrospective cohort study that describes the effectiveness of tofacitinib for the treatment of patients with ulcerative colitis in Lebanon.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

American University of Beirut

Study timelines

Date when funding contract was signed

Planned: 08/11/2021

Actual: 08/11/2021

Study start date

Planned: 30/11/2021

Actual: 30/11/2021

Date of final study report

Planned: 30/03/2023

Actual: 23/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921393 Non_interventional Study Protocol 19 May 2021

Updated protocol

A3921393 Non_interventional Study Protocol amendment 1 V2 29 Apr 2022_clean_Redacted

Regulatory

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