Vedolizumab-5055: Long Term Outcomes of Drug Program for Biological Treatment in Adult Patients With Ulcerative Colitis in Poland (MAZUREK Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48425
• EU PAS number:
  EUPAS32684
• Study ID:
  48425
• Official title and acronym:
  Vedolizumab-5055: Long Term Outcomes of Drug Program for Biological Treatment in Adult Patients With Ulcerative Colitis in Poland (MAZUREK Study)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a multicenter, non-interventional study including retrospective data collection with prospective follow-up. This study will assess outcomes of the treatment introduced in the scope of Drug Program (DP) addressed to adult patients with ulcerative colitis (UC) in Poland after biological treatment caseation describing relapse rate in this cohort in consecutive periods. DP is a reimbursement program authorized by Ministry of Health in this country to grant patients access to highly specialized therapies, e.g. biologics, such as VDZ. The study is based on data collection from all patients enrolled to treatment in DP between January 2019 and July 2019. The study will have two cohorts based on the treatment received: Infliximab and vedolizumab. The Investigators will invite eligible patients for Visit 1 for data collection (Week 26 after last dose in DP). Retrospective data will be collected from medical charts of the patients who did not complete the treatment and agreed to participate in the study on Visit 1. Prospective follow-ups will be conducted only for patients who completed treatment in DP with response or remission. Prospective follow-ups with patients will be conducted through patient’s interview and data will be collected using electronic case report forms (eCRFs) on remote Visit 2 (Week 52 after last dose in DP), Visit 3 (Week 78 after last dose in DP), and Visit 4 (Week 104 after last dose in DP). It is planned that 70 patients who completed DP with response/remission will be prospectively followed-up in MAZUREK study, however, total number of enrolled patients will be higher due to fact that data will also be collected from patients who lost response before treatment completion in the DP. The overall duration to collect the data in this study is approximately 2 years and 2 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 23/10/2019

Actual: 23/10/2019

Study start date

Planned: 07/02/2020

Actual: 02/03/2020

Date of final study report

Planned: 31/10/2024

Actual: 26/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Updated protocol

Vedolizumab-5055-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