A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland

NCT05384080 | Completed

• 1 other identifier: VedolizumabSC-4004
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 11

Brief Summary

The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].

Conditions

Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Persisting on Treatment With Vedolizumab IV Compared to Participants With Treatment Change up to 24 Months

  Baseline up to 24 months

• Time to any Treatment Change

  Baseline up to 24 months

• Number of Participants Who Discontinued Vedolizumab Treatment

  Baseline up to 24 months

• Number of Participants With Reason for Treatment Change

  Baseline up to 24 months

• Number of Participants With Change in Vedolizumab Dosing Frequency

  Baseline up to 24 months

• Number of Participants Who Changed to Another Treatment

  Baseline up to 24 months

Study Arms (1)

Participants With IBD

Participants diagnosed with moderately to severely active IBD (UC or CD) who are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) and National Drug Program (NDP) at baseline or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for 24 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC and NDP.

You may qualify if:

• Participants with moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC and National Drug Program (NDP) at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

You may not qualify if:

• Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
• Current or planned participation in an interventional clinical trial for CD or UC.
• Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

Uniwersytecki Szpital Kliniczny

Wroclaw, Dolnoslskie, 50-556, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Miedzychodzie

Międzychód, Greater Poland Voivodeship, 64-400, Poland

Location

Szpital Kliniczny Im. Heliodora Swiecickiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu

Poznan, Greater Poland Voivodeship, 60-335, Poland

Location

Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Masovian Voivodeship, 04-141, Poland

Location

HT Centrum Medyczne

Tychy, Slskie, 43-100, Poland

Location

Spzoz Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego

Lodz, Łódź Voivodeship, 90-153, Poland

Location

Related Links

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: August 8, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PL (11)