Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants with Adverse Events (AEs), Serious Adverse events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs) and Unexpected ADRs |
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a drug; it does not necessarily have to have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. AESIs occurs during the treatment or follow-up period, are recorded in the special interest such as opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections, malignancies, infusion-related reactions and hypersensitivity, and hepatic injury. ADRs are defined as AEs which are in the investigator's opinion of causal relationship to the study treatment. An Unexpected ADR is an ADR with the nature, severity, or outcome which is not consistent with summary of product characteristics. |
From first dose of study drug up to 6 months after the last dose of study drug (Up to approximately 70 weeks) |
|
| Secondary |
Percentage of Participants with Ulcerative Colitis (UC) and Crohn's Disease (CD) Who Achieved Clinical Response |
Clinical response is defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of =3 from baseline or by physician assessment of clinical response (UC participants) or decrease in Harvey Bradshaw Index (HBI) of =3 points from baseline (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and =5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. |
Weeks 14, 30 and 46 |
|
| Secondary |
Percentage of Participants with UC and CD Who Achieved Clinical Remission |
Clinical remission is defined as SCCAI of =2 from baseline (UC participants) or a HBI =4 (CD participants). SCCAI is composed of six domains: bowel frequency (during day) ranges 0 to >9; bowel frequency (during night) ranges 0 to 6; urgency of defecation ranges none to incontinence; blood in stool ranges none to usually frank (>50% of defecation); general well-being ranges very well to terrible (0-10); and a number of defined extracolonic features of UC (i.e. arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The score of <5 is considered as inactive and =5 is active disease. HBI is composed of five clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. The score <5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. |
Weeks 14, 30 and 46 |
|
| Secondary |
Percentage of Participants with UC and CD Who Had Vedolizumab Discontinuation |
Vedolizumab discontinuation is defined as ceasing vedolizumab, or a treatment gap =90 days between consecutive doses. |
Up to 46 weeks |
|
| Secondary |
Percentage of Participants with UC and CD Who Achieved Mucosal Healing |
Mucosal healing is based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic subscore of =1 point or Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD =4 and at least a 2 point reduction from baseline with no sub-score >1. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60. |
Week 46 |
|
| Secondary |
Percentage of Participants with UC and CD Who Achieved Endoscopic Response |
Endoscopic response is defined as decrease in Mayo endoscopic subscore of =1 point in UC and >50% decrease in SES-CD in CD. Full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic subscore) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe. SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables is scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60. |
Week 46 |
|
| Secondary |
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) |
The SIBDQ is a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It is a 10-item questionnaire that includes questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score is calculated by summing the scores from each domain; the total SIBDQ score ranges from 10 (poor HRQoL) to 70 (optimum HRQoL). |
From Baseline and Weeks 14, 30 and 46 |
|
