A Study of Vedolizumab in Adults With Crohn's Disease (CD)

Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission.Corticosteroid-free defined as no usage of any systemic or locally acting steroid.Corticosteroid-free clinical remission defined as Harvey Bradshaw Index (HBI) less than (<) 5 points and no concomitant corticosteroids.HBI score measures disease activity of CD. Clinical parameters:general well-being (0-4,higher score lower well being),abdominal pain(0-3,higher score more severe pain),number of liquid stools/day, abdominal mass (0-3),higher score presence of swelling in abdomen),complications (score 1/item).Total is sum of individual parameters.Score:minimum 0-no pre-specified maximum score,depends on number of liquid stools, higher scores indicating more severe disease.Biochemical remission defined as C-reactive protein(CRP) and fecal calprotectin (FCal) normalization.Transmural remission defined as bowel wall thickness(BWT) of <3 millimeter (mm) for all bowel segments upon IUS.

Complete remission will be measured by corticosteroid-free clinical, biochemical and transmural remission. Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score is used to measure disease activity of CD. Biochemical remission defined as CRP and FCal normalization. Transmural remission defined as BWT of <3 mm for all bowel segments upon Intestinal Ultrasonography (IUS).

Corticosteroid-free defined as no usage of any systemic or locally acting steroid. Corticosteroid-free clinical remission defined as HBI <5 points and no concomitant corticosteroids. HBI score is used to measure disease activity of CD.

Biochemical remission defined as CRP and FCal normalization.

Transmural remission defined as BWT of <3 mm for all bowel segments upon IUS.

Clinical response is defined as a reduction of greater than or equal to (>=) 3 points from the baseline HBI score. HBI score is used to measure the disease activity of CD.

Transmural response is defined as a minimum reduction of 25 percent (%) of BWT from baseline or absolute BWT less than or equal to (<=) 3 mm upon IUS.

Concomitant therapies for CD including introduction and discontinuation of systemic steroids; any changes and reasons for changing including dosing regimen changes, discontinuation, initiation etc.

IUS is a 6 item questionnaire visual analogue scale (VAS). Out of 6 items, 2 items has score range 1 (completely unacceptable) to 10 (completely acceptable): Item 1-Acceptability as monitoring tool in IBD; and Item 2-Acceptability of other monitoring tools in IBD including 6 sub items with score range 1 to 10. Item 3- IUS examination leading to improvement of knowledge of their illness with score range 1 (totally useless) to 10 (very useful). Item 4: Tolerability of IUS with score range 1 (no discomfort) to 10 (much discomfort). Item 5: Choice of monitoring modality with score range 1 (most preferred) to 5 (least preferred). Item 6: IUS examination leading to improvement of knowledge/understanding of illness including 5 sub-items with score range of 1 (completely disagree) to 10 (strongly agree). Responses to these 6 questions will be summed to maximum score of 145. The total score range represents participant's experience of IUS and their acceptability to this assessment.

The SIBDQ is an instrument used to assess quality of life and is a disease-specific HRQoL questionnaire, that consists of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic, each question is scored on a scale from 1 (a severe problem) to 7 (not a problem at all). The total score will be reported and will range from 10 to 70 with a higher score indicates a better health-related QoL.

Health Care Resources Utilization (HCRU) will be calculated as available in the medical record and captured in the eCRF.