NCT04885920Completed
A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)
Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
Inflammatory bowel disease consists of either ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include the administration choices which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC). Treatment will be determined by the study doctor according to routine clinical practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 12 May 2021
- Start date
- 22 Feb 2022
- Primary completion date
- 12 Mar 2024
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04885920
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 22 Feb 2022 to the primary completion date, 12 Mar 2024
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Current or planned participation in an interventional clinical trial for CD or UC.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 1\. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinicki bolnicki centar Osijek (University medical centre Osijek) Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
| Klinicki bolnicki centar Rijeka (University medical centre Rijeka) Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
| Klinicki bolnicki centar Split (University medical centre Split) Coordinator of this site? Confirm its status | Split | Croatia | Unknown status |
| Klinicki bolnicki centar Zagreb (University medical centre Zagreb) Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice) Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Splosna bolnisnica Celje (General hospital Celje) Coordinator of this site? Confirm its status | Celje | Slovenia | Unknown status |
| Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana) Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| Univerzitetni klinicni center Maribor (University medical centre Maribor) Coordinator of this site? Confirm its status | Maribor | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.