Colitis, Ulcerative, Crohn Disease
Conditions
Keywords
Drug Therapy
Brief summary
Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease. In this study, adults with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. The main aim of the study is to check if participants have side effects from vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Detailed description
This is a non-interventional, prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time. This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions. The study will enroll approximately 500 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (eDC). All participants will be enrolled in a single observational group: • Participants with UC or CD This multi-center trial will be conducted in China. The overall duration of the study will be approximately 72 weeks.
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. Diagnosed with UC or CD 2. Firstly prescribed with vedolizumab
Exclusion criteria
1. Currently enrolled in or plan to participate in any other clinical trials (that is, interventional study) 2. Contraindicated for vedolizumab according to product package insert
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to Week 72 |
| Percentage of Participants With Serious Adverse Events (SAEs) | Up to Week 72 |
| Percentage of Participants With Adverse Events of Special Interests (AESIs) | Up to Week 72 |
| Percentage of Participants With Adverse Drug Reactions (ADRs) | Up to Week 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With UC Achieving Endoscopic Remission | Week 54 | Endoscopic remission in UC is defined as mayo endoscopic sub-score \<=1. Mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 where 0 = Normal mucosa or inactive disease, 1 = Mild activity (erythema, decreased vascular pattern, mild friability), 2 = Moderate activity (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe activity (spontaneous bleeding, large ulcerations). Higher scores indicating more severe disease. |
| Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score | Week 14 | Clinical response in UC is defined as greater than or equal to (\>=) 2 points reduction in partial mayo clinic score and \>=25 percent (%) decrease from baseline score accompanied with \>=1 point decrease in rectal bleeding sub-score or absolute rectal bleeding sub-score less than or equal to (\<=) 1 point. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 sub-scores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. |
| Percentage of Participants With CD Achieving Endoscopic Remission | Week 54 | Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers. |
| Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) | Week 14 | Clinical response in CD is defined as \>=3-point decrease in the HBI score. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 equal to \[=\] very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub-scores, where score less than (\<) 5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (\>) 16 = severe disease activity. |
| Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score | Week 54 | Clinical remission in UC is defined as partial mayo clinic score \<=2 with no sub-score \>1. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 sub-scores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. |
| Percentage of Participants With CD Achieving Clinical Remission Based on HBI | Week 54 | Clinical remission in CD is defined as HBI score of \<=4 points. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 = very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub-scores, where score \<5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and \>16 = severe disease activity. |
Countries
China
Outcome results
None listed