Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44012
• EU PAS number:
  EUPAS32716
• Study ID:
  44012
• Official title and acronym:
  Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a multi-centre, non-interventional, and prospective study. This study will review the medical records of patients to evaluate the effectiveness of treatment with vedolizumab in patients with Crohn’s disease (CD), who are administered vedolizumab in Drug program (DP) 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. All participants will be enrolled in one Cohort, where participants will receive vedolizumab as per standard clinical practice and DP requirements at Visit 1 (Week 0), Visit 2 (Week 14), Visit 3 (Week 54), Visit 4 (Week 78), and Visit 5 (Week 102). 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 data collection in this study is approximately 3 years.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 14/11/2019

Actual: 14/11/2019

Study start date

Planned: 07/02/2020

Actual: 03/03/2020

Data analysis start date

Planned: 01/02/2023

Date of interim report, if expected

Planned: 30/04/2021

Date of final study report

Planned: 01/06/2024

Actual: 24/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

Vedolizumab-5056-clinical-study-protocol-redact.pdf

Regulatory

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