A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease (IBD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
Overview
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.
Detailed description
This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:
• Participants with UC or CD
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
Primary outcome measures
- Percentage of Participants With Serious Adverse Events (SAEs) [Time frame: Up to Week 52]
- Percentage of Participants With Adverse Drug Reactions (ADRs) [Time frame: Up to Week 52]
- Percentage of Participants With Serious Adverse Drug Reactions (SADRs) [Time frame: Up to Week 52]
- Percentage of Participants With Adverse Events of Special Interest (AESIs) [Time frame: Up to Week 52]
- Percentage of Participants With Unexpected Adverse Events (AEs) [Time frame: Up to Week 52]
- Percentage of Participants With Unexpected ADRs [Time frame: Up to Week 52]
Secondary outcome measures (3)
- Percentage of Participants With UC and CD Who Achieved Clinical Response [Time frame: Up to Week 52]
- Percentage of Participants With UC and CD Who Achieved Clinical Remission [Time frame: Up to Week 52]
- Percentage of Participants With UC and CD Who Achieved Mucosal Healing [Time frame: Up to Week 52]
Eligibility criteria
Inclusion criteria
- With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions
Exclusion criteria
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
- With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
- For whom vedolizumab SC is contraindicated as per product label
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Donggguk University Ilsan Hospital — Goyang-si
Identifiers
NCT: NCT05428345 · VedolizumabSC-4003