Vedolizumab-5050: Clinical Perspective of Vedolizumab (Entyvio) use in the Drug Program "Vedolizumab in the Treatment of Ulcerative Colitis" (POLONEZ)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47738
• EU PAS number:
  EUPAS34119
• Study ID:
  47738
• Official title and acronym:
  Vedolizumab-5050: Clinical Perspective of Vedolizumab (Entyvio) use in the Drug Program "Vedolizumab in the Treatment of Ulcerative Colitis" (POLONEZ)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a prospective, non-interventional, national, multi-center study. This study will assess 54-week safety and effectiveness in patients with ulcerative colitis (UC) who are eligible for Drug Program (DP) treatment with vedolizumab in Poland. DP is a reimbursement program authorized by Ministry of Health in this country to grant patients access to highly specialized therapies, example biologics, such as vedolizumab. The study is based on data collection from all patients enrolled for treatment in DP between February 2019 and April 2020. All patients will be enrolled in one Cohort, where patient will receive vedolizumab as per local prescribing information and DP inclusion and exclusion criteria at Visit 1 (Week 0), Visit 2 (Week 14) and Visit 3 (Week 54) or until termination. The follow up Visit 4 (Week 80) will be performed in patients who completed the full treatment schedule within DP. The study will enroll approximately 100 patients who initiated treatment with vedolizumab. The study is planned to be conducted in Poland. The overall duration of this study is approximately 2 years and 5 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 13 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 14/12/2017

Study start date

Actual: 28/02/2019

Data analysis start date

Actual: 06/07/2021

Date of interim report, if expected

Actual: 03/02/2020

Date of final study report

Actual: 06/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

Vedolizumab-5050_Protocol_redacted

Regulatory

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