Vedolizumab-5060: Association Between Disease Activity and QoL, Fatigue, Mood and Sleep Disorders in Patients with Moderate to Severe Ulcerative Colitis or Crohn’s Disease Treated with Vedolizumab - A Prospective, Observational Study Based on Patient Reported Outcomes (KUJAWIAK)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103396
• EU PAS number:
  EUPAS34232
• Study ID:
  103396
• Official title and acronym:
  Vedolizumab-5060: Association Between Disease Activity and QoL, Fatigue, Mood and Sleep Disorders in Patients with Moderate to Severe Ulcerative Colitis or Crohn’s Disease Treated with Vedolizumab - A Prospective, Observational Study Based on Patient Reported Outcomes (KUJAWIAK)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is an open-label, prospective, non-interventional, national, and multi-center study. This study is designed to document the management and clinical outcome of patients who are eligible for Drug Program (DP) treatment in Poland with ulcerative colitis (UC) and Crohn’s disease (CD) based on real-world data. 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 September 2020 and March 2022. All patients will be enrolled in one Cohort, where patient will receive vedolizumab intravenous in accordance to Summary of Product Characteristics (SmPC) and DP. Data collection will be scheduled in line with DP visits at Visit 1 (Week 0), Visit 2 (Week 2), Visit 3 (Week 6), and Visit 4 (Week 14). The follow up will be performed after Week 14 in patients who completed the full treatment schedule within DP. The study will enroll approximately 300 patients who initiated treatment with vedolizumab. The study is planned to be conducted in Poland. The overall duration of this study is approximately 25 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Szymon Drygala

Study timelines

Date when funding contract was signed

Planned: 17/02/2020

Actual: 17/02/2020

Study start date

Planned: 01/09/2020

Actual: 04/09/2020

Data analysis start date

Planned: 30/09/2022

Date of final study report

Planned: 31/08/2023

Actual: 30/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

KUJAWIAK_NIS Protocol_V 2.0_FINAL-amended (V 2.0) updated_Redacted

Regulatory

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