Crohn's Disease, Inflammatory Bowel Disease (IBD), Ulcerative Colitis
Conditions
Keywords
Drug Therapy
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 \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].
Detailed description
This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting. The study will enroll approximately 160 participants: 100 participants with UC and 60 participants with CD. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: •Participants with IBD This single center study will be conducted in Poland at public hospitals and institutions that treat UC and CD. The overall duration of the study will be at least 24 months. Data will be collected at baseline, every 3 months within the first year and every 6 months within the second year, and at the time of switch, discontinuation and/or at routine follow-up visits.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.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.
Exclusion criteria
1. 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. 2. Current or planned participation in an interventional clinical trial for CD or UC. 3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Poland
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed