Clinical trial NCT05428345: A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease (IBD)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll participant with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions

Exclusion Criteria:

1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
3. For whom vedolizumab SC is contraindicated as per product label

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
measure: Percentage of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to Week 52
measure: Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
timeFrame: Up to Week 52
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Up to Week 52
measure: Percentage of Participants With Unexpected Adverse Events (AEs)
timeFrame: Up to Week 52
measure: Percentage of Participants With Unexpected ADRs
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants With UC and CD Who Achieved Clinical Response
timeFrame: Up to Week 52
measure: Percentage of Participants With UC and CD Who Achieved Clinical Remission
timeFrame: Up to Week 52
measure: Percentage of Participants With UC and CD Who Achieved Mucosal Healing
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Donggguk University Ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: