Vedolizumab-4024: A Multi-center, Longitudinal, Observational Study of the Effectiveness of Vedolizumab on Clinical Outcomes and Health-Related Quality if Life in Biologic Naive Patients with Inflammatory Bowel Diseases in Serbia Over a 2-year Period

Study identification

• EU PAS number:
  EUPAS32913
• Study ID:
  45090
• Official title and acronym:
  Vedolizumab-4024: A Multi-center, Longitudinal, Observational Study of the Effectiveness of Vedolizumab on Clinical Outcomes and Health-Related Quality if Life in Biologic Naive Patients with Inflammatory Bowel Diseases in Serbia Over a 2-year Period
• DARWIN EU® study:
  No
• Study countries:
  Montenegro

  Serbia
• Study description:
  This is a non-interventional, longitudinal, prospective, and multi-centre study. This study will assess the long-term benefit in bio-naive patients who are initiating the treatment with vedolizumab for ulcerative colitis (UC) and Crohn’s disease (CD). Patients will receive treatment with vedolizumab under standard clinical practice and will be observed prospectively for 2 years, or until discontinuation of vedolizumab treatment, whichever occurs earlier. The study will review the medical charts of patients to evaluate the effectiveness of treatment with vedolizumab. The study will enroll approximately 140 patients (70 patients with moderately to severely active UC and 70 patients with moderately to severely active CD) who initiated treatment with vedolizumab. The study is planned to be conducted in Serbia. The overall duration of data collection in this study is approximately 2 years after enrollment in the study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Aleksandar Biljic Erski

Clinical Center of Serbia Belgrade, Clinical Hospital Center Zvezdara Belgrade, Clinical Hospital Center Dragisa Misovic Belgrade, Clinical Hospital Center Zemun Belgrade, Clinical Hospital Center Bezanijska Kosa Belgrade, Clinical Center of Vojvodina Novi Sad, Clinical Center of Kragujevac Kragujevac, Clinical Center of Nis Nis, Clinical centre of Montenegro Podgorica

Study timelines

Date when funding contract was signed

Planned: 01/04/2020

Study start date

Planned: 01/04/2021

Actual: 19/04/2021

Data analysis start date

Planned: 01/08/2022

Date of final study report

Planned: 01/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

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